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CDRH Looks to Drugs for Inspiration

CDRH Looks to Drugs for Inspiration

By Jim Dickinson 

When FDA’s current regulatory scheme for medical devices was being invented on Capitol Hill in the 1976 Medical Device Amendments, the universal credo was “don’t emulate drug regulation—medical devices are not drugs.”

So a totally different, less prescriptive matrix came into being, the most striking feature of which was section 510(k), under which new medical devices could enter the market without any FDA action at all, simply on the manufacturer’s notification of intent and sufficient documentation to show “substantial equivalence” to an already marketed, and thus grandfathered, pre-1976 device. FDA could disagree for good reason and prevent marketing, but the new matrix assumed this would be a rarity.

Like any new invention, the new regulatory scheme had its teething troubles. Adjusting interpretations were made in the courts and in Congress over the ensuing years, and there were numerous and typically unconfessed administrative abuses.

But always the 1976 Amendments’ defenders kept up the conceptual mantra: “Devices are not drugs.” Whenever CDRH was asked to look over the wall to its sister Center for Drug Evaluation and Research (CDER) for ideas, a negative chorus arose.

Until now. In what some may see as a tacit admission that “regulation lite” has not been a runaway success, FDA commissioner Margaret Hamburg openly acknowledged before a March hearing of the Senate Health, Education, Labor, and Pensions Committee that CDRH is now looking at approval pathways CDER provides to pharmaceutical companies as a means to build new mechanisms to help speed devices to market.

CDRH, Hamburg said, can learn from CDER and “real-world use with postmarket surveillance and collection of data and additional postapproval studies” that could speed devices that meet an unmet medical need to market.

“That has been a theme of the drug side, and it is part of CDRH’s strategic plan as an approach to integrating postmarket studies into the overall assessment and an ongoing understanding,” she said. “We will be eager to work with stakeholders to shape this pathway as we go forward.”

Relying on postmarketing data to speed device approvals is part of CDRH’s proposed Innovation Pathway, a program intended to put pioneering medical devices on the fast-track to review.

“We put out our Innovation Pathway as a way for engaging with the innovators far earlier in the device development in a shared, collaborative way for us to better understand newer technology,” CDRH director Jeffrey Shuren told a recent industry conference.

“When we don’t have a regulatory pathway in place, then let’s try to figure out that pathway together,” he urged. “What we did with the artificial pancreas is a nice example, and you will see more of that coming out in the future... Another innovative move is to also look at the circumstances where we might be able to shift some of the established premarket data needs into the postmarket setting, either through a more formal data collection process or by leveraging the national medical device surveillance system as we start to get that off the ground.”

A draft guidance is planned and CDRH is looking to obtain more stakeholder input on the proposal.

Newly appointed CDRH associate director for technology and innovation Murray Sheldon told a separate conference that the initial approach to implementing the new pathway involves practicing new review concepts without dismantling CDRH’s core review procedures, including the 510(k), IDE and Premarket Application (PMA).

If proven successful, Sheldon said, new review concepts applied to the more innovative products will be expanded to other existing review programs. He noted that experimentation is now underway with innovative reviews of three products intended to treat end-stage renal disease, chosen from among 32 device applicants.

Other Innovation Pathway projects for 2014 include study of ways to streamline clinical trials, ways to streamline approval to reimbursement (in collaboration with Medicare and CMS), and striking the “right” balance between pre- and postmarket evidentiary requirements.

According to Sheldon, an essential aspect of the Innovation Pathway will be to create a “shared view” of what constitutes program—and product—success. He indicated that reviewers must begin to understand the time-cost of different regulatory choices and work with sponsors to create a more collaborative environment.

The use of FDA’s IT Conference Center, which allows conference participants—sponsors and CDRH staff—to meet via Skype for exchange of views, will help foster and maintain “forward momentum” on innovative projects as they move through the development process.

Jim Dickinson is MD+DI's contributing editor.


Intuitive Stock Surges 13% As It Readies New Surgical Robot

Intuitive Surgical has announced FDA clearance and the U.S. launch of its new da Vinci Xi Surgical System. The company, in a Tuesday news release, described the Xi as a "technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach." The company plans to market the da Vinci Xi System around the world. News of U.S. approval of its latest robotic-assisted minimally invasive surgery system caused Intuitive's stock to rise nearly 13% in value, to nearly $494 per share, at the close of trading Tuesday. It's now up more than 28% year-to-date. "The da Vinci Xi System's new overhead architecture means that multi-quadrant surgery can be performed without repositioning the system, an innovation long sought by surgeons who perform complex procedures," Gary Guthart, Intuitive Surgical's president and CEO, said in a news release. Intuitive needs the boost, because Guthart and other executives in the company have been engaged in damage control in the discourse regarding the safety of Da Vinci robotic surgery. Guthart has complained that despite reported adverse events and ongoing FDA issues, surgery with the Da Vinci system is still far safer than conventional open surgery. Medgadget is also reporting on new competition for Intuitive Surgical from SOFAR, an Italian pharmaceutical firm, that has its own surgical robotics platform: "The Telelap ALF-X features haptic feedback, allowing the surgeon to indirectly 'feel' the tissues that are being manipulated. This can lead to improved safety and allow certain maneuvers to be performed with greater confidence."

da Vinci Xi Surgical System
The arms of Intuitive Surgical's da Vinci Xi Surgical System, as shown on its website.
When it comes to its stock price, Intuitive Surgical is one of the best performing medical device companies of early 2014. But it is also worth noting that it was trading at more than $500 a share a year ago. The da Vinci Xi System expands upon core da Vinci System features, including wristed instruments, 3D-HD visualization, intuitive motion, and an ergonomic design. Improvements upon older models include a new overhead instrument arm architecture designed to facilitate access to a patient from virtually any position; a new endoscope digital architecture that creates a simpler, more compact design; an ability to attach the endoscope to any arm, improving visualization; and smaller, thinner arms with newly designed joints to improve range of motion.
Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
Intuitive Surgical also plans to seek regulatory clearance to make the da Vinci Xi System compatible with Intuitive Surgical's Firefly Fluorescence Imaging System.

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

MDEA 2014 Finalists: General Hospital Devices and Therapeutic Products

General Hospital Devices and Therapeutic Products 

IsoGel AIR | LuViva | MetaNeb | MuV | RENASYS Soft PortSmartSite VialShield

IsoGel AIR therapeutic support surface. Manufactured and submitted by Stryker Medical (Portage, MI). IsoGel AIR assists in managing pressure, shear, and microclimate through its unique cover and open-column design that results in low air loss through its proprietary gel. Supply and design credit to Hilco Technologies (Grand Rapids, MI), Dartex Coatings Ltd. (Acton Close Nottingham, Nottingham, UK), and Tridien Medical (Corona, CA).

LuViva Advanced Cervical Scan point-of-care, noninvasive cervical disease detection device. Manufactured by Guided Therapeutics Inc. (Norcross, GA). Entry submitted by Big Bang (Decatur, GA). LuViva is a test for early detection of the disease that leads to cervical cancer. It does not require a tissue sample. The test provides an immediate and objective result at the point of care, reducing false-positive and false-negative results. Supply and design credit to Big Bang (Decatur, GA), Seaway Plastics Engineering (Port Richie, FL), Gupta Permold Corp. (Pittsburgh, PA), and Herman Miller Inc. (Zeeland, MI)
MetaNeb system. Manufactured and submitted by Hill-Rom Services Pte. Ltd. (Singapore). MetaNeb is indicated for mobilization of secretions, lung expansion therapy, and treatment and prevention of pulmonary atelectasis. It can also provide supplemental oxygen when used with compressed oxygen.


MuV patient transfer system. Manufactured by CEGA Innovations LLC (Sioux Falls, SD). The MuV system is lightweight and ergonomically designed to reduce patient stress and the physical toll on hospital workers during patient transfer, reducing workplace injuries and increasing efficiencies and reimbursement criteria. Entry submitted by and supply and design credit to Kablooe Design (Blaine, MN).


RENASYS Soft Port. Manufactured and submitted by Smith & Nephew Inc. (St. Petersburg, FL). RENASYS Soft Port offers patient comfort and increased placement versatility (for difficult wound locations), and functions when folded or kinked. Due to the soft construction, the risk of pressure sores may be reduced. Supply and design credit to Ximedica (Providence, RI).

SmartSite VialShield closed-vial access device. Manufactured and submitted by Yukon Medical LLC (Research Triangle Park, NC). The SmartSite VialShield is a needle-free closed system transfer device that protects clinicians from exposure to hazardous drugs during drug preparation and administration. It is designed to optimize safety, simplify care, and minimize costs. Supply and design credit to Gilero Biomedical Research (Triangle Park, NC), and Industrie BORLA S.p.A. (Moncalieri, Torino, Italy). 

Drug-Delivery Devices and Combination Products Implant and Tissue-Replacement Products

MDEA 2014 Finalists: Drug-Delivery Devices and Combination Products

Drug-Delivery Devices and Combination Products 

Auvi-Q | Debioject | FOX Handheld Nebulizer | MedCenter | PROPEL

Auvi-Q epinephrine auto-injector. Manufactured by Sanofi (Bridgewater, NJ). Entry submitted by Kaléo Pharma (Richmond, VA). Auvi-Q is a single-use epinephrine autoinjector used to treat life-threatening allergic reactions (anaphylaxis). It is the size and shape of a credit card, the thickness of a cell phone, and includes a unique voice instruction system. Supply and design credit to Kaléo Pharma (Richmond, VA) and Medivative Technologies (Indianapolis). 

DebioJect intradermal drug-delivery device. Manufactured and submitted by Debiotech SA (Lausanne, Switzerland). The DebioJect was conceived to overcome the problems encountered with classical intradermal delivery techniques. The innovative microneedle allows both pain-free and precise injection of up to 500 μL in a few seconds. Supply and design credit to CEA-LETI (Grenoble, France), Mecaplast SA (Botterens, Switzerland), and the Royal Institute of Technology (KTH) (Stockholm, Sweden).


FOX Handheld Nebulizer. Manufactured by and submitted by Vectura GmbH (Germany). The FOX inhaler is a fast and efficient handheld nebulizer for treatment of respiratory diseases. Its breathing control enables highly accurate drug delivery to the small airways, ensuring optimal therapeutic results of the inhaled liquid medications. Supply and design credit to Ian Mahaffy Industrial Design Ltd. (London, UK).


MedCenter pharmacy kiosk. Manufactured and submitted by MedAvail Technologies Inc. (Mississauga, Canada). The MedAvail MedCenter enables a remote pharmacist in a call center to provide confidential, real-time professional advice and verify the automated dispense of prescription medications to patients at the kiosk. Supply and design credit to Squint Innovation & Branding Inc. (Toronto, Canada).


PROPEL mometasone furoate implant and PROPEL mini mometasone furoate implant. Manufactured and submitted by Intersect ENT (Menlo Park, CA). PROPEL and PROPEL mini dissolvable steroid-releasing implants reduce the need for additional surgical procedures and for oral steroids, which can have serious side effects, for patients suffering from chronic sinusitis.
Dental Instruments, Equipment, and Supplies General Hospital and Therapeutic Devices

MDEA 2014 Finalists: Dental Instruments, Equipment, and Supplies

Dental Instruments, Equipment, and Supplies 

Bluephase Style | Digit Power dispenser | Solea | Zoom!

Bluephase Style curing light featuring Polywave LED. Manufactured and submitted by Ivoclar Vivadent AG (Schaan, Liechtenstein). Bluephase Style is a cordless high-performance LED curing light that polymerizes all light-curing dental materials. Its ergonomic and compact design enables it to fit comfortably into the user’s hand. Supply and design credit to Rigami Design (Diepoldsau, Switzerland).
Digit Power dispenser for Aquasil Ultra Cordless tissue managing impression system. Manufactured and submitted by Dentsply International, LD Caulk Division (Milford, DE). The Digit Power dispenser enables dentists to precisely place Aquasil Ultra Cordless impression material directly into the sulcus. This system minimizes work time violations and the use of retraction cord while providing significant time savings. Supply and design credit to Nordson EFD LLC (East Providence, RI) and Key Tech (Baltimore). 
Solea CO? dental laser system for hard and soft tissue. Manufactured by Convergent Dental Inc. (Natick, MA). Entry submitted by HERNETICS (Chelsea, MA). At 9.3 μm, Solea is the first CO? laser system ever cleared by the FDA for hard and soft tissue ablation. Solea is fast, precise, virtually noiseless, and anesthesia-free for the vast majority of procedures. Supply and design credit to HERNETICS (Chelsea, MA), Tischler Resources (Acton, MA), and Sachem Engineering, R&D (Arlington, MA). 
Zoom! Teeth Whitening System. Manufactured by Discus Dental Philips Oral Healthcare (Culver City, CA). Entry submitted by DeviceLab Inc. (Tustin, CA). Zoom! will change teeth color up to eight shades within 45 minutes. It has settings to avoid unpleasant feelings during and after the process. Supply and design credit to DeviceLab Inc. (Tustin, CA) and Solid Concepts (Valencia, CA). 
Critical-Care and Emergency Medicine Products Drug-Delivery Devices and Combination Products

Which MedTech Companies Raised The Most Money in March?

 Which MedTech Companies Raised The Most Money in March?

Fundraising these days is similar to a Herculean task that involves competing with other medical device companies who are courting investors, courting investors who are increasingly skittish about medtech. The five below, which tapped the private and public markets, are an exception to the general medtech fundraising narrative. Notably, two of them are based outside the U.S.

The top five deals were:

Name of Company: Domain Surgical
Location: Salt Lake City, Utah
Amount Raised: $35 million in equity and debt
Investors: unnamed medtech company, OrbiMed, BioStar Ventures, as well as existing investors, board members and         management.
Domain Surgical has developed the FMwand Ferromagnetic Surgical System is a hemostatic dissection device that uses pure thermal energy to cut and coagulate tissue. The device doesn’t pass any electrical current through the patient.

Name of Company: Axonics Modulation Technologies
Location: Irvine, California
Amount Raised: $32.6 million
Investors: Edmond de Rothschild Investment Partners (EdRIP) was the lead investor with participation from NeoMed Management, Legend Capital, and angels.
Product: Axonics is developing an implantable neuromodulation device to treat chronic pain and overactive bladder

Name of Company: Invendo Medical
Location: Kissing, Germany and Garden City, New York
Amount Raised: 22.5 million euros ($28 million)
Investors: Xeraya Capital, a German Family Office, TVM Capital, Wellington Partner, 360° Capital and the founders invested.
Product: FDA-cleared single-use colonoscope - Invendoscope- operated using a hand-held device

Name of Company: Neovasc
Location: Vancouver, Canada
Amount Raised: C$25 million ($22.5 million)
Investors: Public markets in Canada
Product: It makes various products including the Neovasc Reducer(TM) for the treatment of refractory angina and the Tiara(TM) transcatheter mitral valve replacement device in development for the treatment of mitral regurgitation.

Name of Company: Oculeve
Location: San Francisco
Amount Raised: $16.7 million
Investors: Unknown in this round. Previous investors include Kleiner Perkins Caufield Byers, Versant Ventures and NEA among others.
Product: The company reportedly has developed a small implantable device that can stimulate tear secretion and is aimed at patients suffering from dry-eye symptoms.

-- By Arundhati Parmar, Senior Editor, MD+DI

MDEA 2014 Finalists: Critical-Care and Emergency Medicine Products

 Critical-Care and Emergency Medicine Products

ARKON | Hemolung RASIsolibriumRP-VITATrueCPR

ARKON anesthesia delivery system. Manufactured by Spacelabs Healthcare (Snoqualmie, WA). ARKON allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow. Entry submitted by and supply and design credit to Design Concepts Inc. (Madison, WI).
Hemolung RAS extracorporeal carbon dioxide removal system. Manufactured and submitted by ALung Technologies Inc. (Pittsburgh). Hemolung RAS provides respiratory dialysis, a simple, minimally-invasive form of extracorporeal carbon dioxide removal (ECCO?R) that acts as an alternative or supplement to mechanical ventilation in cases of acute respiratory failure.
Isolibrium critical-care air support surface. Manufactured and submitted by Stryker Medical (Portage, MI). Isolibrium aims to provide tools for nurses to care for patients while its advanced pressure redistribution system helps prevent pressure ulcers in patients. Supply and design credit to Humphrey Products Co. (Kalamazoo, MI), Grand Rapids Foam Technologies (Grand Rapids, MI), Les Produits Plastitel Inc. (Laval, Quebec, Canada), Twisthink (Holland, MI), and Derby (South Bend, IN).
RP-Vita remote presence telemedicine robot. Manufactured and submitted by InTouch Health Inc. (Santa Barbara, CA). RP-VITA enables increased access to specialist care through high-acuity telemedicine consults. It eliminates the need for telemedicine-specific staffing. RP-VITA’s intuitiveness, ease-of-use, and safety features encourage physician adoption and clinical use. Supply and design credit to iRobot (Bedford, MA).
TrueCPR coaching device. Manufactured and submitted by Physio-Control (Redmond, WA). TrueCPR helps improve CPR performance by giving rescuers real-time feedback on the quality of chest compressions in accordance with current guidelines. It also provides instant postevent review, allowing rescue teams to debrief more efficiently. Supply and design credit to Plexus (Neenah, WI).
Back to Introduction   Dental Instruments, Equipment, and Supplies  

Thoratec LVAD Recall Gets Class I Status

The FDA on Tuesday issued a Class I recall designation over Thoratec's advisory involving four patient deaths related to its HeartMate II left ventricular assist device (LVAD).

HeartMate II
HeartMate II, as shown on Thoratec's website
The issue actually has nothing to do with the LVAD itself, but rather is related to patients and caregivers who were unable to understand instructions and lacked the training needed to hook up a back-up system controller in cases of device alarm or malfunction. Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, according to Pleasanton, CA-based Thoratec and the FDA. The FDA elaborates on what happened:
"All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller."
Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
Thoratec sent an "Urgent Medical Device Correction" letter by email to all affected customers in early March. The company is updating labeling and training materials for the HeartMate II LVAS Pocket System Controller and has been urging physicians, caregivers and patients to get up to speed on the new instructions and training. Thoratec isn't the only company experiencing potentially deadly issues around device instructions. The FDA has also been warning that a Greatbatch Medical Orthopedic surgical tool could cause serious injury or death because it came with inadequate sterilization recommendations.

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9 Ways Medical Devices Fail 7 Recent Medical Device Failures Catching FDA's Eye Medical Device Recalls Growing at Slower Pace Than Industry Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

CoreValve Beats Traditional Valve Replacement in Trial


Medtronic's CoreValve transcatheter aortic valve replacement device. (Courtesy Medtronic)

Medtronic has announced the results of two studies testing its CoreValve transcatheter aortic valve replacement product, which were presented at the American College of Cardiology's 63rd Annual Scientific Session in Washington, DC.

The High Risk Study of the CoreValve US Pivotal Trial met its primary endpoint with a low one-year, all-cause mortality rate of only 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgical aortic valve replacement (SAVR). "We're making continual progress. It's not only an alternative but may be a preferable alternative [to open heart surgery]," said David Adams, MD, a co-principal investigator in the study in an interview with Reuters.

Final four-year follow-up results from the CoreValve CE Pivotal Study, which demonstrated excellent long-term durability in patients with severe aortic stenosis who were treated with the CoreValve System, were also announced.

The CoreValve High Risk Study, simultaneously published in The New England Journal of Medicine, showed that the CoreValve System is superior to SAVR in patients with severe aortic stenosis who are considered high risk for surgery.

Medtronic says this is the first and only study to show the superiority of a transcatheter aortic valve over conventional surgery. Its CoreValve System met its primary study endpoint with higher than expected survival. All-cause mortality at one year was only 14.2% in patients receiving the CoreValve System, versus 19.1% in patients receiving SAVR. This difference calculates to be a 26% decrease in mortality risk.

Major stroke rates in patients who received the CoreValve System were 3.9% at 30 days and 5.8% at one year, versus 3.1% at 30 days and 7.0% at one year for patients who received SAVR. Medtronic says these stroke rates were low and not statistically different. This finding is said to be important because stroke is one of the complications most concerning to physicians and patients because it increases mortality and affects quality of life.

Stephen Levy is a contributor to Qmed and MPMN.