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Novel Gel Boosts Blood Flow in Patients with Arterial Disease

An injectable gel derived from the natural scaffolding in human muscle holds promise for treating arterial disease, say engineers at the University of California, San Diego.

Kristopher Sturgis


The tissue from skeletal muscle of pigs suspended in detergent eventually yields fibrous extracellular matrix remains for injection. 

A new treatment could be used to treat poor blood circulation caused by advanced peripheral artery disease, a condition that can lead to infection and limb amputation.

The idea derives from a similar approach to repairing heart muscle used on pigs, says Karen Christman, professor of bioengineering at UC San Diego and senior author of the paper describing the work.

"We had initially developed a similar material that showed significant promise for repairing the heart after a heart attack," Christman said. "This previous material was derived from the natural scaffolding, or extracellular matrix, of pig hearts. We therefore developed this new material derived from the extracellular matrix of skeletal muscle to treat the damaged muscle in peripheral artery disease patients."

Christman and her team recently tested the injection therapy procedure on rats suffering from the disease and found that the use of natural scaffolding from muscle tissue improved the blood flow and promoted muscle remodeling.

"We injected a gel that sets up into a porous and fibrous material in the damaged tissue," Christman says. "It then provides a new scaffold and appropriate cues for the body's cells to migrate into and help repair the damaged region, improving the blood vessel network, and helping to regenerate muscle tissue."

In their study, Christman found that the hydrogel actually increased the diameter of the rats' arterioles, which promptly led to improved blood flow to the limbs. Study results showed that in just 35 days, the animals treated with the injection therapy had restored healthy muscle tissue comparable to rats unaffected by arterial disease. The promising results could make the injection treatment a possible solution to a disease that doesn't offer many treatment options.

"Most people have looked at cell or growth factor therapies," Christman said. "To date, injectable biomaterials have mainly been examined for delivering these cell or growth factor therapies. To our knowledge, no one has developed an injectable material scaffold to treat both the low blood flow and muscle damage associated with peripheral artery disease."

Approximately 10 million Americans suffer from PAD, according to the National Center for Biotechnology Information. The condition can lead to a bevy complications including tissue damage decreased blood flow, and tissue necrosis --  and as these symptoms escalate, they can result in limb amputation and even death. Restoring natural blood flow for these patients is critical, however, practical therapy solutions have been difficult to come by, and as a result, amputation is required in many severe cases.

In the future, Christman hopes to continue to adapt the method to explore other disease models to see where this kind of injection therapy can have a similar impact. The group also plans to refine the safety protocols so that this treatment option can be produced on a larger scale to treat as many patients as possible.

With over 200,000 amputations performed a year in North America and Europe alone due to poor circulation and arterial disease complications, Christman believes this kind of therapy could be a promising solution for countless patients worldwide.

"If successful, this could improve blood flow in critical limb ischemia patients -- the most severe and advanced form of peripheral artery disease -- to prevent amputations and other complications, while being significantly less expensive than cell therapies."

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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FDA Panel Gives Thumbs Up to Abbott's Absorb

FDA Panel Gives Thumbs Up to Abbott's Absorb

Any doubts as to how an FDA panel would review the first fully-resorbable cardiac stent were put to rest when the panel voted to recommend approval.

Based on FDA documents, it was clear that the agency was concerned about the safety of the drug eluting stent when implanted in patients with small vessel sizes. In general adverse events were also noted when compared against Abbott's own Xience drug eluting stent although they were statistically insignificant. An analyst perusing those documents had speculated that the approval might come with a caveat about implanting in only larger-sized blood vessels.

While that may still happen, on Tuesday, the FDA Circulatory Devices Panel voted 10-0 that the Absorb GT1 Bioresorbable Vascular Scaffold is effective while in a 9-1 vote, panel  members found Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System is safe for use in patients who meet the criteria specified in the proposed indication. 

Here is the proposed indication that Abbott is seeking - The Absorb GT1 BVS is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length is less than or equal to 24 millimeters mm) with a reference vessel diameter of greater than or equal to 2.5 mm and less than or equal to 3.75 mm.

The panel was concerned about adverse events with respect to smaller vessel sizes but felt that Abbott's proposed warning is adequate. Here is the warning: If quantitative imaging determines a vessel size less than 2.5 mm, do not implant Absorb. Implantation of the device in vessels less than 2.5 mm may lead to an increased risk of adverse events such as myocardial infarction and scaffold thrombosis.

The panel voted on a third question of whether the benefits of Absorb outweigh its risks, the panel voted 9-0 in favor of the device, with one abstention. The market adoption of the device post approval will be where this question will fully be answered.

European physicians, where the device is available, have lauded the concept of a drug eluting cardiac stent that leaves nothing behind but candidly admitted that the device is too expensive. Some even mention that the benefits may be felt several years after the procedure.

In the U.S. it used to be that once the FDA hurdle is overcome, medical reimbursement from the Centers for Medicare and Medicaid Services would be a no brainer. Those days appear to be changing. Previously, a reimbursement consultant described the difference in the philosophy between FDA and CMS.

"FDA operates under the mantra of 'safe and effective' but not everything that is 'safe and effective' is considered 'reasonable and necessary' by Medicare for coverage," said Edward Black says.

An Abbott spokesman didn't immediately respond to a question about the prospects for reimbursement for Absorb.

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

Investigators Incentivized to Go after Device Execs?

Investigators Incentivized to Go after Device Execs?

A recently-acquitted medtech executive has angrily aired objections to how federal prosecutors handled his case. Could a recent memorandum from the deputy attorney general have motivated the government’s approach?

Jim Dickinson

Could the loss of revenue from the now-suspended medical device excise tax in Obamacare be offset by a new revenue stream from the industry through fiscally-motivated federal civil and criminal prosecutions launched against individual device executives for alleged “corporate wrongdoing”?

Recent guidance issued to federal law enforcement by deputy attorney general Sally Yates has, in the eyes of one medical device executive, unleashed bullying tactics among ambitious Department of Justice trial attorneys and local U.S. Attorney’s Office investigators.

Feasibly, they’re incentivized by the seven-page Yates memorandum issued on September 9, 2015 to go after high-dollar coerced settlements of cases that previously might have been dealt with differently, triaged according to degrees of public harm, or not brought forward at all due to substantive triviality.

Get inspired to innovate during Massachusetts Medtech Week—register for BIOMEDevice Boston 2016, April 13-14.

Significantly, the six-step strategy in the memo departs from previous DoJ policy in numerous ways, but perhaps most pointedly in Step 6, where it advises focusing on “considerations beyond [the] individual’s ability to pay.” In other words, previous policy might let the individual off in favor of going after his or her corporation’s deeper pockets instead.

Now, the individual is not to be bypassed in a new scheme that fuses the efforts of DoJ’s criminal and civil prosecutors through better and ongoing communications with each other on every case.

One of the first medical device executives to feel the full bite of the new approach was Minneapolis-based Vascular Solutions CEO Howard Root, who in November was indicted on factually deficient felony counts for allegedly selling unapproved lasers to treat varicose veins and for “conspiring to defraud the United States by concealing the illegal sales activity.”

Strangely, this was not an FDA prosecution, but was brought on its own initiative by the U.S. Attorney’s office in San Antonio, Texas on the basis of a former Vascular Solutions salesman’s $20 million whistleblower complaint to that office. Root says FDA had no complaints about his sales practices because the device use at issue did have 510(k) clearance.

Although the San Antonio U.S. Attorney’s office consulted with the DoJ Civil Division’s Consumer Protection Branch in Washington, which is the branch that usually handles FDA prosecutions, FDA provided only one witness to testify when the case came to trial—CDRH Division of Surgical Devices supervisory biologist Neil R. Ogden.

He testified that the language in the devices’ 510(k) clearance could indeed be read as covering the allegedly “unapproved” use in the San Antonio U.S. Attorney’s Office’s initiating complaint.

With that, and other weaknesses in the prosecution’s case, Vascular Solutions elected not to bring any of its 20 defense witnesses to the stand, and the jury threw out all the charges.

Root and his company walked out unscathed, except for the estimated $25 million in legal expenses their defense and the preceding investigation had cost them.

Unlike most industry CEOs who win in court against the government and keep quiet, Root wasn’t ready to let the acquittal be the end of the matter.

In a March 3 Minneapolis Star Tribune commentary piece, he blasted the prosecutors for the “malicious” way they went after him and his company.

Early on, he wrote, he had offered to meet with the prosecutors and “correct their misinformation, but two days before that scheduled meeting, they called my lawyer and canceled it. And they never would reschedule. So before deciding to bring criminal charges, these prosecutors never heard my side of the story.”

As they pushed ahead, Root’s commentary said, the prosecutors subpoenaed over 2 million pages of company documents and interviewed over 60 customers and employees, receiving evidence that conflicted with the whistleblower’s story.

“But instead of changing their conclusions to fit the evidence, these prosecutors engaged in obscene tactics to try to change the evidence,” Root wrote.

“In conversation with our lawyers,” he continued, “they called conflicting statements by witnesses ‘a line of [expletive].’ They referred to one employee as ‘a poor [expletive]’ who needed to return ‘on bended knee’ to ‘fix’ his testimony. They told a female employee to think about what would happen to her firstborn son if she were indicted because she refused to ‘cooperate. And by ‘fix’ and ‘cooperate,’ I mean retract their prior testimony and support the government’s case.

“Why would prosecutors act this way? The answer is pretty simple. They started with bad information, jumped to a conclusion, and then, in these prosecutors’ own words, they had ‘invested their blood, sweat and tears’ in this case and ‘needed a body’ in return.”

Asked why he had paid $520,000 in 2014 to settle a civil DoJ action alleging he had caused false claims to be submitted to the federal government for the same devices, Root told me the investigation was then costing him that much every quarter and if he mounted a court defense he would have ended up paying $2-3 million in legal costs.

If the potential for crass revenue-sharing of settlements is not a sufficient incentive for zealous prosecutors to bring poorly researched cases like this against medical device companies, Root (who is himself a lawyer) points to professional advancement incentives through copious merit awards handed out annually by DoJ to its lawyers.

Then factor in the new scheme established by the Yates memo, which lists its six strategy steps as:

"(l) in order to qualify for any cooperation credit, corporations must provide to the Department all relevant facts relating to the individuals responsible for the misconduct; (2) criminal and civil corporate investigations should focus on individuals from the inception of the investigation; (3) criminal and civil attorneys handling corporate investigations should be in routine communication with one another; (4) absent extraordinary circumstances or approved departmental policy, the Department will not release culpable individuals from civil or criminal liability when resolving a matter with a corporation; (5) Department attorneys should not resolve matters with a corporation without a clear plan to resolve related individual cases, and should memorialize any declinations as to individuals in such cases; and (6) civil attorneys should consistently focus on individuals as well as the company and evaluate whether to bring suit against an individual based on considerations beyond that individual's ability to pay."

Meanwhile, two other medical device executives are to go to trial under the Yates memo in Boston in May on charges of conspiracy, securities fraud, wire fraud, aiding and abetting, and distributing adulterated and misbranded devices when they were leading their 2004 startup ENT device company Acclarent, Inc., now owned by Johnson & Johnson’s Ethicon.

They are former CEO and president William Facteau, of Atherton, California, and former vice president of sales Patrick Fabian, of Lake Elmo, Minnesota.

Their indictments allege they misled FDA in a 510(k) that their Stratus device was a nasal sinus spacer substantially equivalent to an approved spacer for a maximum 14 days post-surgical use when it was really designed to provide sustained release “over an extended period” in the sinuses of the steroid Kenalog-40 (triamcinolone acetonide injection in suspension).

They allegedly drove up the selling price of Acclarent through off-label sales of Stratus, according to the indictment.

If DoJ’s evidence in this case is as poorly researched as it was in the Vascular Solutions case, another government defeat might be in the offing.

Jim Dickinson is MD+DI's contributing editor. 

[Image courtesy of SIMON HOWDEN/FREEDIGITALPHOTOS.NET]

Meet the BIOMEDevice Boston Innovation Prize Finalists

An affordable professional-grade 3-D printer and easily customized medical device motors are among the exhibitor innovations that will compete at the April 13-14 show in Boston.

Chris Newmarker

Visit BIOMEDevice Boston and help us pick the BIOMEDevice Boston Innovation Prize winner among these five finalists, gleaned out of a group of 10 semifinalists. (The Innovation Tour to pick the winner will depart from Center Stage at 1 p.m. on Wednesday, April 13.) 

Formlabs Form 2 3-D Printer
The Form 2 (Image courtesy of Formlabs)

Formlabs (Booth #1113)

An Affordable Professional-grade 3-D Printer

Formlabs (Somerville, MA), which has a professional grade 3-D printer called the Form 2 that costs $3,499, won the Minnesota Medtech Week Innovation Prize in November after impressing a tour group of attendees at the Minneapolis show. They're hoping to repeat the same feat in Boston.

The Form 2 uses a precisely guided laser to cure a photopolymer resin. The company boasts that the technology allows for unprecedented accuracy and precision at an affordable price point. Such stereolithography 3-D printing technology has run into the tens of thousands of dollars in the past.

"The Form 2 keeps production in-house. In a few hours, you can create multiple high-resolution prints at a low cost. This process is much cheaper, faster, and easier," the company boasts in its entry.

Maxon Precision Motors Inc. (Booth #412)

Easy and Fast Motor Customization

In November 2015, Maxon (Fall River, MA) introduced its ECX program, which is built around a line of high speed, sterilizable motors for medical device applications such as hand held tools, respirators, and instrumentation.

The company says in its entry: "Maxon's X program offers design engineers the ability to customize their micro drive online quickly and easily. The configurator provides a step by step assembly of the DC drive based on the design engineers' specifications. They can configure the gear stages, the motor bearings, the shafts, the encoder, and much more. Mechanical and electrical data, dimensional drawings, and CAD files can be downloaded immediately after the configuration has been completed. Maxon's lean automated process ensures that all drive versions are ready for shipment within 11 days."

Proto Labs (Booth #304)

An Automatic Interactive Quoting System for Prototyping

Quick-turn manufacturer Proto Labs (Maple Plain, MN) was runner-up for the MD&M West Innovation Prize with its automatic interactive quoting system for prototyping.

ProtoQuote is an automated interactive quoting system. It had its latest software version released last year. Using ProtoQuote, medical device engineers can upload their 3-D CAD model and receive free design for manufacturability analysis and real-time pricing information within hours. ProtoQuote enables OEM engineers to make needed prototype modifications early and often, according to Proto Labs.

Proto Labs says in its entry: "The software has been continuously enhanced to now offer a very detailed design analysis including an interactive three-dimensional image, which allows developers to review their part geometry and assess any potential design issues that are highlighted. The process is so automated that these interactive quotes are provided within hours."

RTP Co. (Booth #333)

RTP 2000 HC plastics
 
Image courtesy of RTP Co.

Thermoplastics to Stand Up Against Hospital Disinfectants

RTP Co. (Winona, MN) in May 2015 announced the development of its RTP 2000 HC series of thermoplastic compounds. The RTP 2000 HC series is meant to stay tough when it comes to hospital disinfectants, maintaining strength, functionality, and integrity after repeated exposure. Based on a proprietary alloy technology that combines resins and additives, the RTP 2000 HC plastics open up new possibilities, according to RTP. "The RTP 2000 HC series provides a viable solution to a widespread problem: the damage and premature, catastrophic failure of plastic devices, equipment, and housings caused by harsh cleaners and disinfectants used in medical settings," the company says in its entry.

The plastics could enable better design of devices such as mobile ultrasound and x-ray machines, enteral feeding devices, drug infusion pumps, blood filtration equipment, and more.

The RTP 2000 HC series allowed RTP to become a semifinalist for the Minnesota Medtech Week Innovation Prize last year.

SUSE (Booth #405)

Live Operating System Patching

Enterprise Linux company SUSE (Cambridge, MA) has pioneered technology to perform "live patching" that does not require a reboot of kernel. SUSE says in its entry: "Using live patching, you can easily apply a kernel patch when you need to and not wait for a system shutdown." The live patching technology was part of the SUSE Linux Enterprise 12 Service Pack 1 introduced in recent months.

The live patching is beneficial for medical device OEMs because it increases service availability, reduces planned or unplanned downtime, and maintains security and stability, according to SUSE. The company was an MD&M West Innovation Prize for innovations related to the SUSE Linux Enterprise 12 Service Pack 1.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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New Shapeshifting 3-D Material Could Make for Better Stents

Harvard University researchers developed a new, flexible, versatile material, which can be fine tuned to change its size and shape to adapt to different environments.

Kristopher Sturgis

via GIPHY

The new material is a structure made of thin walls that can be folded, molded, and reshaped. The result is objects whose size, volume, and shape can be altered to form any number of architectural structures or objects.\

Harvard researchers and engineers created the material with a composition that can be continuously reshaped and controlled, and can even be embedded with a programmed actuator so that it can take shape on its own.

The group's work could represent a new class of versatile, bendable materials that can vary in size from the nanoscale to the meter-scale--making the material useful in a variety of different ways from portable architectural structures to surgical stents. Johannes T.B. Overvelde, a graduate student from Harvard and first author on the paper describing the work, says that origami principles inspired the design. The structure is is made from extruded cubes with 24 faces and 36 edges.

"Like origami, the cube can be folded along its edges to change shape," Overvelde says. "In our paper, we demonstrate (both theoretically and experimentally with a centimeter-scale prototype) that the cube can be deformed into many different shapes by folding certain edges, which act like hinges. We furthermore embedded pneumatic actuators (air pockets) into the structure, which can be programmed to deform specific hinges--changing the cube's shape and size, and removing the need for external force."

These pneumatic actuators are what enable the cubed device to fold its edges, altering its size and shape on its own. Overvelde says the material can be fitted with any kind of actuator, including electric, thermal, and even water mechanisms. WIth similar technologies relying on standard mechanics, this new material offers the unique ability to self integrate its surface and shape to form a desired structure, including potential medical applications.

"I certainly think the metamaterial can be used to build medical stents," Overvelde said. "Depending on the design, the volume and shape of the metamaterial, it can be changed considerably. Another interesting feature could be to include heat actuation in the stent, so that it automatically deploys when bringing it into contact with an environment that is above room temperature."

The latest prototype is a cube comprised of 64 connected individual cells that can grow, shrink, bend, and fold to form different shapes with varying degrees of stiffness. Enacting these actuated changes in material properties actually adds a fourth dimension to the material, enabling users to simply know what they need to actuate in order to get the material to form the desired shape.

"By using various types of actuation, this material can be programmed to interact with its environment in different ways as it changes shape," Overvelde says. "If one were to make a wall from this material, for example, it could be folded in different ways to manipulate sound or light. Or it could be used to form a roof that autonomously opens on a hot day to allow fresh air to come in, or close when it starts to rain." 

Overvelde says the material could even be used in the arena of drug delivery, in which the shape of the metamaterial can change over time to increase or decrease the exposed surface area. For now, the group is focused on exploring all the different possibilities for this uniquely versatile material.

"This structural system has fascinating implications for dynamic architecture," Overvelde says. "Depending on the characteristic size of the structure, it could be applied today in many ways. The main challenges lie in reducing the size of the structure down to the micro or even nano-scale. We are currently working on generalization of the extruded cube design, to create a database of metamaterials, all with their own unique properties."

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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Surgeon Accused of Human Experimentation in Lawsuit Trial

The lawsuit in Chicago is against the chief of cardiac surgery at Northwestern University. Patrick McCarthy, MD, is accused of improperly experimenting on patients with Edwards Lifesciences' Myxo Ring--a device he invented. Northwestern Medicine says McCarthy was merely doing what doctors are supposed to do: provide the best care possible for his patients.


Patrick McCarthy Northwestern
Patrick McCarthy, MD

Qmed Staff

Updated March 21, 2016

A jury trial is underway this week over a malpractice lawsuit against Patrick McCarthy, MD, a surgeon and inventor accused of experimenting with an uncleared cardiovascular device on his patients.

Plaintiff Maureen Obermeier claims that McCarthy about 10 years ago inserted a Myxo Ring mitral valve device into her heart without her consent, and that the device resulted in a 2006 heart attack and other complications. McCarthy is the top cardiac surgeon at Northwestern University's teaching hospital. He also happens to be the Myxo Ring's inventor.

"He was putting it into patients, seeing how it worked, and not telling them," Obermeier's attorney Adrwin Boyer said during opening statements, according to Fox 32 in Chicago.

The judge in Chicago previously dismissed Edwards Lifesciences, the Myxo Ring's maker, as a defendant in Obermeier's lawsuit. Besides McCarthy, Northwestern Memorial Hospital and the Northwestern Medical Faculty Foundation are being sued.

McCarthy has strenuously denied the accusations that he implanted an experimental device into roughly 100 patients without informed consent in 2006 and 2007. He told the Chicago Tribune in 2011 that both he and Northwestern Memorial Hospital had received assurances from Edwards that it was cleared for use under FDA rules.

"Dr. McCarthy used a legally marketed device because he determined that it was the best annuloplasty ring to repair the patient's diseased valve. He chose it because it was in the best interest of the patient," Northwestern Medicine says in a statement shared with Qmed. The statement said McCarthy's work was not a clinical research study, though he did publish an outcomes research paper based on the 100 patients.

The statement also notes: "In this case, the court granted summary judgment in favor of Edwards Lifesciences, the manufacturer of the ring, because the plaintiff failed to provide any evidence or testimony that the ring was unsafe or defective."

The Myxo ring--a device designed to treat degenerative myxomatous disease of the mitral valve--appears to have been one of a number of apparent disconnects over medical device indications that have taken place in the U.S. over the past 10 years.

Edwards Lifesciences claimed it could sell the device because it was substantially equivalent to other previously 510(k) cleared mitral valve replacement devices. FDA, however, disagreed. It  required Edwards to change the name of the device before granting an investigational device exemption (IDE)--all done after-the-fact. Even after all of that, FDA still issued a warning letter referencing the Myxo under its new device name "dETlogix." FDA deemed the device misbranded because the company had failed to report serious adverse events.

FDA ordered McCarthy to stop implanting the Myxo Ring until appropriate regulatory clearance was obtained, according to a 2009 letter from the FDA congressional office to then-Sen. Richard Lugar, R-IN.

In the case of the Edwards Lifesciences rings, more than 6000 adverse events are listed in FDA's MAUDE database.

Edwards ended up removing the Myxo device from the U.S. market, describing the move as a "voluntary retrieval" in its 2009 SEC 10-K filings. An identical Myxo device, though, was recently still on the market in Europe.

"Patient safety is always our top priority, and we stand by the safety and efficacy of the Myxo ring," says Edwards Lifesciences spokesperson Sarah Huoh. "As it pertains to this case, Edwards received a dismissal on motion for summary judgment, which typically occurs when the facts are insufficient to support the plaintiff's claims. The Myxo ring used in the treatment of the patient in this case has the same design as the device that is described in the 510(k) clearance provided by FDA."

"Edwards Lifesciences considered this matter concluded when the FDA provided 510(k) clearance for the Myxo ring in April 2009," Huoh adds. "The discussion as it relates to this device is one of process, not patient safety, and Edwards has been transparent on the regulatory processes we have followed. The company has focused significant efforts on future innovations for mitral valve therapy and, as part of this commitment to advancing the field of heart valve repair and replacement and our ongoing planning for the introduction of newer devices, we have retired certain products, including the Myxo ring." 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Abbott Closer to FDA Approval of Absorb Stent

The independent panel of experts convened by FDA decided that the benefits of Abbott's Absorb bioresorbable drug eluting coronary stent outweigh the risks.

Abbott Absorb
Abbott's new Absorb bioresorbable scaffold (Courtesy Abbott Laboratories)

Nancy Crotti

An FDA advisory committee has voted that the benefits of a bioabsorbable cardiac stent designed by Abbott outweigh the risks, according to the company.

FDA could issue a PMA for the Absorb fully resorbable stent in the fourth quarter of this year, a stock market analyst from RBC Capital predicted in a report in financial news outlet The Fly. The analyst added that Absorb would likely be a "niche device," pending longer-term data, the report said.

The FDA panel also voted 9 to 1 in favor of the device's safety and 10 to 0 on its efficacy, the company said. Panel members reviewed data from multiple studies of the Absorb dissolving stent.

Prospects for the technology appear uncertain after a recent clinical trial found that the technology was merely "noninferior" to Abbott's metallic Xience drug-eluting stent. Despite the fact that the Absorb did not prove itself to be superior to the Abbott Xience stent, non-inferiority was the primary endpoint of the clinical trial.

The trial found that patients who received an Absorb dissolving stent experienced comparable rates of specific adverse events--including heart disease-related death, heart attacks attributed to the stented artery, and repeat procedures--as compared to patients who received the Xience stent.

Bioabsorbable stents have been hailed as one of the most promising technologies in cardiology for the past 10 years or so. Last year, Boston Scientific beat Abbott to become the first company to market bioabsorbable polymer stents in the U.S.

In a submission to FDA, Abbott described the Absorb GT1 Bioresorbable Vascular Scaffold as "a temporary coronary scaffold comprised of a fully bioresorbable scaffold and bioresorbable polymer coating" that is "naturally resorbed by the body in two to three years." Metal stents are permanent implants that restrict arterial motion for the life of the patient.

"In multiple randomized clinical trials, the Absorb bioresorbable vascular scaffold has demonstrated comparable outcomes to the leading permanent metallic stent," said Gregg W. Stone, MD, director of cardiovascular research and education at the Center for Interventional Vascular Therapy, Columbia University Medical Center and New York-Presbyterian Hospital. "As a first-in-kind device with novel properties, including complete dissolution and natural restoration of vessel function, this is a remarkable achievement."

Stone chaired the Absorb clinical trial program.Abbott submitted its PMA application for the Absorb dissolving stent in mid-2015 to FDA, which convened the advisory committee. The company expects a decision on the PMA later this year.

The latest news about Absorb provides some good news for Abbott--especially welcome after recent problems with another cutting-edge technology out of Abbott, its MitraClip percutaneous mitral valve repair system

One month ago, FDA announced that Abbott Vascular has received nine reports of its MitraClip delivery system failing to detach from the Clip, which resulted in the death of one patient and open-heart surgery to extract the device. The problem can also cause its mandrel component to fracture.

Abbott recalled the delivery system and provided updated instructions and training for clinicians using the device.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Nancy Crotti is a contributor to Qmed and MPMN.

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The Biggest Mistake Entrepreneurs Make with FDA

The Biggest Mistake Entrepreneurs Make with FDA

Regulation can be a challenge for startups. Hear what one expert said was the biggest mistake she saw entrepreneurs make in approaching FDA during her years at the agency.

Marie Thibault

It can be tough to accommodate both disruptive innovation and regulation.

That was one main takeaway from a session this week at the 2016 South by Southwest Conference (SXSW) loaded with practical tips for the healthcare-focused entrepreneur. Experts, including a veteran of FDA, spoke candidly about the burdens—and blessings—of regulation in medtech, digital health, and other areas of healthcare.

The panel, titled "Under My Thumb: Regulation and Healthcare Disruption," was held Monday at SXSW in Austin, TX. 

Entrepreneurs should not extoll how disruptive their product will be when interacting with FDA regulators, said Heather Rosecrans, vice president of regulatory affairs at the Medical Device Manufacturers Association and executive vice president of medical devices and combination products at Greenleaf Health LLC. Rosecrans was previously director of the 510(k) pre-market notification staff at CDRH. The biggest mistake a company can make at FDA, she said, is presenting a new invention as disruptive. "The greater you say it is," she said, the more FDA "digs in." Later in the discussion, Rosecrans added, "saying this will change the practice of medicine is not the best way to approach [FDA]."

Learn more about "Out of the Box Thinking While Playing by the Regulatory Rules" at BIOMEDevice Boston 2016, April 13-14.

Instead, entrepreneurs should find ways to build bridges or highlight similarities to other devices or inventions that have already received regulatory go-ahead, said James Eadie, MD, MBA, a principal at Santé Ventures. "Don't disrupt everything," he said, urging the importance of stepping stones and the way entrepreneurs tell the product's story.

The challenge with labeling your product a "disruption" is that FDA will likely require the product to go through the PMA route to regulatory approval instead of the less-taxing 510(k) process, which the large majority of medical devices use to reach the U.S. market. The length and risks of the PMA pathway has historically meant that venture capital firms would say "no way" to funding such a product, said Eadie.

Health-related companies can't risk forging ahead without a plan of strong regulatory advice, Eadie said in response to a question about whether it is easier to ask for forgiveness or ask for permission when it comes to regulatory strategy. The wrong decision or assumption could potentially mean wasting millions of dollars and years on clinical studies that may not be what a regulator needs to see. That approach, he said, doesn’t involve just asking for forgiveness, but may mean asking for “a pink slip!”

Still, regulation doesn't have to be a threat to the entrepreneur. Eadie noted that FDA is becoming more "reasonable"—strong praise from a venture capitalist—and said the agency's initiatives, including allowing more cardiovascular early feasibility studies in the United States, have helped narrow the domestic innovation gap with Europe.

Finally, regulation can be a win for a startup, Eadie said, because successfully navigating its challenges could result in a period of market exclusivity and derisk the path forward.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET ]  

More Olympus Duodenoscopes Get Validated Reprocessing Updates

More Olympus Duodenoscopes Get Validated Reprocessing Updates

Marie Thibault

Olympus Corporation of the Americas continues to update instructions for cleaning and disinfecting its duodenoscopes. In an FDA safety communication Tuesday, the agency told users of the Olympus TJF-160F and TJF-160VF duodenoscopes that the company had released validated, new manual reprocessing protocols for those models and that those instructions had passed regulatory scrutiny. 

In a March 14 letter to customers, Laura Storms, vice president of Regulatory Affairs and Quality Assurance at Olympus America, wrote that the updated cleaning protocol involves the use of a new brush, MAJ-1534, which is reusable after sterilization in an autoclave. The company is initially sending customers one free box of the new brushes for each of scope owned. 

The protocol changes require personnel to perform additional steps in flushing, brushing, and using more flushing volume in the forceps elevator recess area, the elevator wire and channel, and endoscope channels.

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Duodenoscopes hit the headlines in 2015 because of infectious outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) associated with contaminated duodenoscopes at several U.S. hospitals. Olympus is one of three manufacturers that sells duodenoscopes in the United States—the other two, FUJIFILM Medical Systems and PENTAX Medical have also validated revised reprocessing instructions. Olympus America validated new reprocessing instructions for its TJF-Q180V scope in March 2015. More recently, FDA granted 510(k) clearance in January 2016 to a modified design of that duodenoscope that is intended to prevent contamination of the closed elevator channel on the instrument. The prior version of the TJF-Q180V scope had not received FDA clearance because the company did not believe the device required a new 510(k) application since it was a modification of a previously-cleared scope.  

Olympus America has been working on revising the reprocessing protocol for the TJF-160F/VF models for about a year, according to the FDA safety communication. The company sent test protocols and validation data to FDA in March 2015 but the agency decided "more robust testing was necessary to demonstrate an adequate safety margin." Updated protocols were accepted in the months after and in the fall, Olympus sent cleaning and disinfection reports to FDA; in January FDA told Olympus that the revised instructions were "adequate," the agency wrote. 

Customers are instructed to throw away prior versions of the TJF-160F/VF  reprocessing manual and train personnel to use and put the new protocol into practice immediately.

"The agency believes that when followed, these updated, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of Olympus 160 F/VF duodenoscope models," FDA wrote in its safety communication. 

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET ]  

The 10 Most Innovative BIOMEDevice Boston Suppliers

An affordable professional-grade 3-D printer and an automatic interactive quoting system for prototyping are but some of the innovations among the 10 BIOMEDevice Boston Innovation Prize semifinalists. Help us pick the five finalists that will compete at the April 13-14 show.

Chris Newmarker

Motors, operating systems, cables, coatings, 3-D printers, software--there are many innovations to be had on the floor of a major UBM medical device show such as BIOMEDevice Boston. Any one of them could potentially enable important medical device innovations.

What do you think are the most important types of innovations? Qmed's editors have selected 10 semifinalists for the BIOMEDevice Boston Innovation Prize. Check them out, and then answer our survey to help us pick the five finalists competing at the show.

Alpha Wire (Booth #335)

Cables for Tinier Medical Devices

Alpha Wire (Elizabeth, NJ) is touting its micro-coaxial cables, which it says are ideal for miniature video signal requirements.  The cables, available starting in April, utilize high-strength alloys. They could aid in a wide range of applications, from sensitive medical imaging to minimally invasive medical devices such as endoscopy. Standard sizes range from 32 down to 50 American wire gauge.

Alpha Wire says in its entry: "While there are other micro-coaxial cables on the market, Alpha Wire is offering standard sizes in stock from 50 to 32 AWG and custom composite designs as well. The competition focuses mostly on custom and not off-the-shelf SKUs."

Formlabs
From left to right, the Form 2 3-D printer, Jory Block of Formlabs sales, JP Shipley of Formlabs marketing, Teresa Atwood of Formlabs operations, and the sign touting their winning of the Minnesota Medtech Week Innovation Prize. (Photo by Chris Newmarker)

Formlabs (Booth #1113)

An Affordable Professional-grade 3-D Printer

Formlabs (Somerville, MA), which has a professional grade 3-D printer called the Form 2 that costs $3,499, won the Minnesota Medtech Week Innovation Prize in November after impressing a tour group of attendees at the Minneapolis show. They're hoping to repeat the same feat in Boston.

The Form 2 uses a precisely guided laser to cure a photopolymer resin. The company boasts that the technology allows for unprecedented accuracy and precision at an affordable price point. Such stereolithography 3-D printing technology has run into the tens of thousands of dollars in the past.

"The Form 2 keeps production in-house. In a few hours, you can create multiple high-resolution prints at a low cost. This process is much cheaper, faster, and easier," the company boasts in its entry.

Keyence Corp. of America (Booth #740)

An Instant Measurement System to Reduce Inspection Time

Keyence Corp. of America (Woodcliff Lake,  NJ) says its IM-6225 instant measurement system--released in September 2014--does away with the need for optical comparators, hand calipers/micrometers, measuring microscopes, and GD&T and profile measurement systems.

"The system has the ability to identify the part, pull up the correct program, and measure up to 100 dimensions per part on up to 100 parts on the stage at once," Keyence says in its entry. "The system will automatically adjust the lighting, focus, and re-positions the program to match each part on the stage. It recognizes the profile and reflective images of each part, compares it to pre-programmed tolerances, produces a pass or fail for each dimension, and saves the data locally or to a network. Finally with one more button press, it prints out a full inspection report. All of this being accomplished in 3 seconds!"

Maxon Precision Motors Inc. (Booth #412)

Easy and Fast Motor Customization

In November 2015, Maxon (Fall River, MA) introduced its ECX program, which is built around a line of high speed, sterilizable motors for medical device applications such as hand held tools, respirators, and instrumentation.

The company says in its entry: "Maxon's X program offers design engineers the ability to customize their micro drive online quickly and easily. The configurator provides a step by step assembly of the DC drive based on the design engineers' specifications. They can configure the gear stages, the motor bearings, the shafts, the encoder, and much more. Mechanical and electrical data, dimensional drawings, and CAD files can be downloaded immediately after the configuration has been completed. Maxon's lean automated process ensures that all drive versions are ready for shipment within 11 days."

MTD Micro Molding (Booth #437)

Molding Super Tiny Medical Device Parts

MTD Micro Molding (Charlton, MA) specializes in molding tiny parts for the medtech industry. The company claims it has a unique advantage because it has the tool builder, process engineer, metrologist, and automation group all under one roof. Says the company: "If we run a mold and have an issue, we can get our tooling people together with the molding engineers to compare notes and make improvements on the fly. Revisions are made instantly, and we apply that learning as we go forward, so we won't make the same mistake again."

ProPlate/Professional Plating Inc. (Booth #155)

A Coating-based Braided Catheters Innovation

After becoming an MD&M West Innovation Prize finalist last month with its Torq-Lok braided catheter coating innovation, ProPlate (Anoka, MN) is back as a finalist for the Boston competition. Torq-Lok debuted 2014. The patented process atomically bonds metal directly to each braid pic, fusing them together as one at each crossing. Preliminary testing of Torq-Lok compared to non-coated braids demonstrated a range of 30-66% greater torque response, a 66% increase in torque to failure, and a 90° twist increase, according to ProPlate. Torq-Lok could allow for more braided catheter innovation because it allows for the braid pic count to be reduced. This, in turn, reduces material costs and production time for the braid manufacturers.

ProPlate has also been innovative in other ways. Its Vizi-Band metal coating process allowed it to become a Minnesota Medtech Week Innovation Prize semifinalist last year.

Proto Labs (Booth #304)

An Automatic Interactive Quoting System for Prototyping

Quick-turn manufacturer Proto Labs (Maple Plain, MN) was runner-up for the MD&M West Innovation Prize with its automatic interactive quoting system for prototyping.

ProtoQuote is an automated interactive quoting system. It had its latest software version released last year. Using ProtoQuote, medical device engineers can upload their 3-D CAD model and receive free design for manufacturability analysis and real-time pricing information within hours. ProtoQuote enables OEM engineers to make needed prototype modifications early and often, according to Proto Labs.

Proto Labs says in its entry: "The software has been continuously enhanced to now offer a very detailed design analysis including an interactive three-dimensional image, which allows developers to review their part geometry and assess any potential design issues that are highlighted. The process is so automated that these interactive quotes are provided within hours."

RTP Co. (Booth #333)

RTP 2000 HC plastics
 
Image courtesy of RTP Co.

Thermoplastics to Stand Up Against Hospital Disinfectants

RTP Co. (Winona, MN) in May 2015 announced the development of its RTP 2000 HC series of thermoplastic compounds. The RTP 2000 HC series is meant to stay tough when it comes to hospital disinfectants, maintaining strength, functionality, and integrity after repeated exposure. Based on a proprietary alloy technology that combines resins and additives, the RTP 2000 HC plastics open up new possibilities, according to RTP. "The RTP 2000 HC series provides a viable solution to a widespread problem: the damage and premature, catastrophic failure of plastic devices, equipment, and housings caused by harsh cleaners and disinfectants used in medical settings," the company says in its entry.

The plastics could enable better design of devices such as mobile ultrasound and x-ray machines, enteral feeding devices, drug infusion pumps, blood filtration equipment, and more.

The RTP 2000 HC series allowed RTP to become a semifinalist for the Minnesota Medtech Week Innovation Prize last year.

SUSE (Booth #405)

Live Operating System Patching

Enterprise Linux company SUSE (Cambridge, MA) has pioneered technology to perform "live patching" that does not require a reboot of kernel. SUSE says in its entry: "Using live patching, you can easily apply a kernel patch when you need to and not wait for a system shutdown." The live patching technology was part of the SUSE Linux Enterprise 12 Service Pack 1 introduced in recent months.

The live patching is beneficial for medical device OEMs because it increases service availability, reduces planned or unplanned downtime, and maintains security and stability, according to SUSE. The company was an MD&M West Innovation Prize for innovations related to the SUSE Linux Enterprise 12 Service Pack 1.

Vention Medical (Booth #632)

A Universal Handle for Medical Devices

Vention Medical (Marlborough, MA) is touting its Versatility universal handle, a 0-24 Fr handle that can be incorporated into a steerable device, catheter, or sheath. Vention says in its entry: "The Versatility universal handle eliminates the need to design and tool a handle in-house, so you can test concepts faster."

The handle became available in September 2014, and the mini handle was launched in January 2016.

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Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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