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Bos Sci Thinks Outside the Box to Gain Market Share

Bos Sci Thinks Outside the Box to Gain Market Share

On the first quarter earnings call, Boston Scientific’s CEO discussed the company’s strategy of signing distribution agreements to drive market leadership.

Marie Thibault

Boston Scientific’s Vercise DBS System is part of the company’s collaboration agreement with Brainlab AG.

While much of the medical device industry has traditionally focused on mergers and acquisitions to gain stronger market positions, Boston Scientific has also been employing distribution agreements and sales collaborations to extend its market reach.

The company has partnerships with C.R. Bard, Frankenman, and most recently, Brainlab AG. Under a collaboration announced on April 27, Boston Scientific will distribute Brainlab’s deep brain stimulation (DBS) surgical planning portfolio along with Boston Scientific’s own Vercise DBS System, which has CE Mark.

The Marlborough, MA-based company has signed a slew of agreements over the past few months, including a deal in February with C.R. Bard Inc. to distribute Bard’s Lutonix 035 Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty Catheter in the United Sates, and a strategic alliance in mid-April with Frankenman Medical Equipment Company. The agreement with Frankenman, a Chinese company, will mean Boston Scientific becomes a company shareholder and the two companies will cooperatively develop, manufacture, and sell products in China.

Mike Mahoney, president and chief executive officer of Boston Scientific, explained the company’s strategy on the April 28 earnings call. According to a Seeking Alpha transcript, Mahoney said, “So we want to grow faster than the market and expand our margin throughout, double-digit EPS [earnings per share] growth. And I think when you look at the rationale for many of those deals, it’s really about driving category of leadership and being the preferred clinical partner to our physicians…And so we really use these JVs [joint ventures] to help fill in potential areas in the portfolio that may be gaps as we continue to drive category of leadership.”

Mahoney noted that Brainlab’s strong relationships with neurosurgeons provides Boston Scientific with an advantage in selling its DBS system and the Bard agreement complements Boston Scientific’s peripheral vascular portfolio.

As for the Frankenman agreement, Mahoney said, “We’re excited about it. It’s our first JV into China. That business has been growing plus 25% and gives us stronger local capabilities that will build on our R&D and manufacturing capabilities, and we think it will accelerate the growth in endoscopy.”

Besides these agreements, Boston Scientific remains active in the M&A space. In recent months, the company has announced acquisitions of Xlumena Inc. and American Medical Systems' urology portfolio.

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

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

[Image courtesy of Boston Scientific Corp.]

FDA Files Consent Decree Against Medtronic and its CEO

FDA Files Consent Decree Against Medtronic and its CEO

Arundhati Parmar

Medtronic's SynchroMed II Implantable Infusion Pump

A new report from Lifescience Alley, a Minnesota life sciences association, describes how Medtronic, Boston Scientific and St. Jude Medical account for 91% of worldwide neuromodulation sales.

And yet it is this neuromodulation unit of Medtronic that has landed the Irish medtech company in hot water with the FDA. On Monday, the federal agency announced that it has filed a consent decree against Medtronic, it's CEO Omar Ishrak, and the president of the neuromodulation unit, Thomas Tefft, for repeatedly failing to correct violations.

The agency charges that the violations relate to the manufacturing of the SynchroMed II Implantable Infusion Pump Systems that deliver drugs via a programmable implantable device to treat primary or metastatic cancer, chronic pain and severe spasticity. The devices are manufactured at the company's neuromodulation facilities located in Columbia Heights, Minnesota.

Until the matter is resolved, Medtronic cannot legally manufacture and sell the new SynchroMed II Implantable Infusion Pump Systems unless a physician determines that it is medically necessary for a patient, the FDA announcement states. 

The agency first approved the Synchromed II Implantable Infusion Pump Systems in 2004. Two years later FDA first identified problems with how they were being manufactured. Such problems can lead to over- or under-infusion, or a delay in patient therapy.

Between 2006 and 2013, FDA conducted five inspections that generated three warning letters, according to the FDA news release. The violations include "inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications" FDA notes.

"Medtronic has been working under a Warning Letter for some time now in Neuromodulation (issued August 2012), and it seems that things were just taking too long for the FDA," wrote Joanne Wuensch, an analyst with BMO Capital Markets in a research note on Monday. 

The company will be required to hire an independent expert who can help to develop and submit plans for correcting the problems. Wuensch noted that Medtronic has already agreed with FDA on design changes to the SynchroMed device, improvements to its quality system, and ways to keep the device available to physicians should they deem it necessary.

For instance, if patients need a replacement drug infusion pump, Medtronic will need to collect a physician certification before providing a SynchroMed drug infusion pump. The company is required to inform both the physician and the patient about the consent decree with FDA, explained Cindy Resman, a Medtronic spokeswoman, in an email. For new patients, Medtronic has to collect documents from the physician showing that the SynchroMed drug infusion pump is medically necessary.

"Efforts are well underway to address issues included in the consent decree and we will continue our work to implement design changes to the SynchroMed drug infusion pump and enhance the Neuromodulation quality system," Resman wrote. "We are committed to working collaboratively with the FDA to address their expectations in a timely and thorough manner."

The SynchroMed device accounts for less than 1% of Medtronic's overall sales, according to Wuensch, the analyst with BMO Capital Markets. In fiscal 2015, which will end on April 30, sales of the device are estimated to be $306 million worldwide with $204 million expected to come from U.S. sales.

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

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center

FDA Looks to Downclassify Some PMA Devices

FDA Looks to Downclassify Some PMA Devices

Marie Thibault

Since February 2014, CDRH has been reviewing PMAs that were approved prior to 2010 as part of its priority to "Strike the Right Balance Between Premarket and Postmarket Data Collection." As a result, some of these products have been determined to be candidated for reclassification to Class II, instead of their current, more stringent Class III classification.

By the end of 2014, CDRH had reviewed 69% of the product codes for actively-market PMA products and has categorized each of these codes into one of four lists:

  • Devices that are candidates for Class II reclassification
  • Devices that are candidates for a shift to postmarket controls or postmarket data collection
  • Devices that experience a reduction or shift in data collection and/or reclassification in 2014, during the review
  • Devices that should remain Class III with no changes in data collection

The list of devices considered candidates for Class II reclassification is 21 items long, including product codes for artificial saliva, bone growth stimulator, single-use female condom, and a medical image analyzer. There are also 21 devices on the list of those that could be candidates for a shift to postmarket controls or postmarket data collection. These include toric intraocular lens, an inflatable penis prosthesis, and a percutaneous cardiac ablation catheter for the treatment of atrial flutter.

Three device product codes already underwent a reduction or shift in data collection or reclassification in 2014, including a stair climbing wheelchair, an endovascular graft system for treatment of aortic aneurysm, and a nucleic acid amplification system for detection of mycobacterium tuberculosis complex.

Most of the reviewed devices will remain Class III, including pacemaker pulse-generators and electrodes, replacement heart valves, cochlear implants, carotid stents, and many more.

On April 23, Senators Richard Burr (R–NC), Michael Bennet (D–CO), and Orrin Hatch (R–UT) introduced the Advancing Breakthrough Devices for Patients Act to create a priority review process for cutting-edge medical devices. Industry group AdvaMed praised the legislation, but patient activist and physician Hooman Noorchashm MD, PhD, who has campaigned to ban electric morcellators and is also advocating for CDRH reform blasted the bill. In an April 28 e-mail to legislators and journalists, Noorchashm called the bill "a serious danger to patient safety in the United States and abroad." He continued, "it is simply unacceptable for the United States Congress to be 'streamlining industry' any further when patient safety stands demonstrably compromised in the United States."

CDRH has been focused on shortening device approval timelines with initiatives like the recently-commenced Expedited Access Pathway Program for innovative devices addressing severe diseases. At an April 28 Senate Committee on Health, Education, Labor, and Pensions hearing on America's medical innovation, Jeffrey Shuren MD, JD, director of CDRH, pointed out that device approval times have gotten shorter in recent years. He said that since 2010, the approval time for 510(k) submissions have been cut by 10% with a 30% reduction in pending applications, while PMA approval times have been cut by 26% with a 43% reduction in pending applications. As for de novo applications, Shuren said the agency has taken two years off the review process timeline for those submissions.     

Despite faster approvals, Shuren admitted that CDRH has been struggling with high turnover and difficulty competing against industry for top talent because of factors like a heavy workload and lower pay.

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

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

[Top image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Controversy Escalates around Birth Control Device

Several women treated with the Essure device have died although the manufacturer insists that the product is safe.

Qmed Staff

EssureThe Essure permanent birth control device from Bayer Healthcare (Leverkusen, Germany) has won considerable negative attention in recent memory. FDA is launching an investigation into the device after five women died after being treated with it. To date, more than 4500 adverse events related to the device have been filed with the agency.

The Law Offices of Koch Parafinczuk & Wolf, PA filed a petition with FDA that convinced the agency to launch the investigation into the device, which is marketed as an alternative to tubal ligation. The petition asks the FDA commissioner to acknowledge that the PMA that granted for the device "has been violated," explaining that the clinical study mentioned in the PMA application was "replete with fraud." The petition claims that patients involved had their answers on clinical trial paperwork crossed out by applicants to downplay the incidence of pain and adverse events associated with the device. It points to the sworn testimony of the clinical trial participants to support this claim.

In 2013, famed consumer advocate Erin Brokovich launched an online campaign to have the device removed from the market. Brokovich maintains that the device is not an effective birth control method, despite its manufacturer's claim that it is 99% effective. She also states that the device is unsafe. She launched a petition to have the device pulled from the market, which has attracted nearly 13,000 signatures to date.

Roughly 750,000 women have been treated with the device.

Earlier this month, Bayer responded to sister publication MD+DI by stating, in part, that it "stands behind the safety and efficacy of Essure and will aggressively defend itself in Court. FDA has closed the petition and forwarded it to the Office of Compliance. We are cooperating with the FDA, and we will respond to any questions that the agency may have related to the allegations."

Complaints claiming that the device is unsafe state the the metal coils of the device can occasionally come dislodged from the fallopian tubes, cutting other organs.

After the most recent death associated with the device, Bayer stated: "Death is not a known failure mode related to Essure."

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

FDA Comes Down on Medtronic over Infusion Pump Faults

The agency has filed a consent decree against the company and two of its two executives.

Qmed Staff

SyncroMed II
The Syncrhomed II device has been cited in a number of Class I recalls in recent years.

An FDA consent decree alleges that Medtronic has repeatedly failed to address manufacturing problems related to its Synchromed II implantable infusion pump.

First approved in 2004, the device can sometimes inaccurately deliver medication or delay its delivery.

FDA inspections of the company's facilities in Columbia Heights, MN have reported major violations. Carried out from 2006 and 2013, FDA's inspections of those facilities resulted in three warning letters, which stated that the firm did not follow good manufacturing processes for corrective and preventive action (CAPA), design controls, and complaint handling. In particular, the warning letters state that the company did not have an adequate process for identifying quality problems, failing to document design changes, and failing to ensure that the finished product complied with design specifications. The problems were said to be unresolved for years.

Used for patients suffering from cancer, chronic pain and severe muscle spasms, the Synchromed II device has also been mentioned in several Class I recalls in recent years, which have cited battery, labelling, and electrical problems related to the device.

The consent decree, which named the company's CEO, Omar Ishrak, and senior vice president, Thomas Tefft, requires Medtronic to halt the manufacture and distribution of Synchromed II pumps except for limited exceptions. It was filed in the U.S. District Court of Minnesota.

The decree also stipulates that Medtronic hire a third-party expert to correct manufacturing violations. Once such problems are resolved, the company can resume manufacturing and distribution of the devices, but is required to submit audit reports to the agency.

In a statement, Medtronic noted that "[p]atients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement."

In addition, Medtronic has also set up a dedicated website related to the consent decree with FDA, located at http://facts.synchromed.com.

Medtronic's stock ticked down $1.40, or 1.8%, on Monday to $76.21.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

2 Major Minneapolis Medtech Shows to Be Staged Together

LifeScience Alley's partnership with UBM Canon brings two major Twin Cities medtech shows under one roof.

Chris Newmarker

Minnesota-based trade group LifeScience Alley will produce a medical technology conference in conjunction with UBM Canon's MD&M Minneapolis under a new partnership formally announced Monday.

The deal brings together two of the largest medical device events held in one of the largest medical device hubs in the United States. (Qmed and Medical Product Manufacturing News are UBM Canon media brands.)

MD&M Minneapolis is slated for November 4-5. The combined Minneapolis event is expected to bring in more than 7500 manufacturers, suppliers, and business leaders under one roof as part of a new Minnesota Medtech Week.

Conference attendees will receive complimentary access to the entire show floor, which includes exhibits from a host of medical device suppliers ranging from manufacturing robotics to tubing suppliers to polymers to electrical components--and much more.

"By leveraging the strengths and industry partnerships of LifeScience Alley and MD&M Minneapolis, we plan to bring the Minnesota medical device community the best thought-leading content and supply chain access possible," Shaye Mandle, president and CEO of LifeScience Alley, said in a news release.

Stephen Corrick, senior vice president and portfolio director for UBM Canon, added, "This partnership with LifeScience Alley demonstrates our mutual dedication to world renowned medtech innovation in the region."

Major medtech companies in the region are also applauding the move. "This event will continue to emphasize the dominant role Minnesota's Medical Alley plays in transforming health care for patients, physicians and hospitals around the world," said Rachel Ellingson, vice president of global communications for St. Jude Medical.

UBM Canon is a major events and community-building company in the medtech industry. Upcoming conferences include BIOMEDevice Boston, May 6-7, 2015, and MD&M East in New York City, June 9-11, 2015.

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

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Bright Ideas from the Latest Startups

Bright Ideas from the Latest Startups

The newest class of startups from NYC-based Blueprint Health debuted at the accelerator's Demo Day on April 24. These young companies are focused on improving patient care, speeding personalized therapies, and increasing revenue for physicians and hospitals.  

Marie Thibault

The latest healthcare startups are fixated on giving physicians and hospitals the tools to offer better patient care in a faster, more convenient way. Oh, and they're making sure these stakeholders can bring in more revenue or save money at the same time. 

Hundreds of healthcare-savvy folks crowded into the City Winery in NYC's SoHo neighborhood on April 24, eager to hear from the new graduates of Blueprint Health's Winter 2015 accelerator program. Seven entrepreneurs pitched their startups—and investment opportunities—to an audience that included venture capitalists.

Here, we highlight four device- and diagnostic-related startups from the Demo Day:

GlucoIQ capitalizes on the fact that Medicare began paying physicians $40 per patient per month for putting in place a diabetes care management program. According to founder Adithya Ganesh, that payment is contingent on the program allowing doctors to review glucose data each month, including 20 minutes of phone conversation between the patient and a nurse, and enabling a 24/7 messaging capability. GlucoIQ makes it easier for physicians to implement such a program, with software that allows for real-time, HIPAA compliant data collection from patients' insulin pumps. Ganesh, a Thiel fellow, explained that the company's business model allows for roughly $120 of Medicare's annual payment per patient to go to the physician, potentially adding tens of thousands in revenue for the practice. This also gives GlucoIQ a market opportunity of more than $1 billion. GlucoIQ can be reached at glucoiq@blueprinthealth.org

GlucoIQ's Ganesh presents during Blueprint Health's Demo Day.

Moving Analytics also builds upon the idea of remote patient care, but focuses on cardiac rehabilitation programs. Co-founder Harsh Vathsangam noted that heart attack patients who participate in cardiac rehab programs reduce their risk of having a second heart attack by half, but that only 20% of patients take part in rehab, often because of the required burden of in-person sessions. Patients had to go to 36 rehab sessions and potentially pay as much as $1800 out-of-pocket for the therapy, Vathsangam explained. Until recently, billing for cardiac rehab was only allowed for in-person visits. Now, Moving Analytics has made it possible for patients to go through the cardiac rehab program remotely, by providing a digitized version of the MULTIFIT standard-of-care program. As explained during the pitch, patients get a personalized plan from a nurse, who checks in with patients weekly on the phone. Patients complete the various goals of the rehab program and can chat with caregivers using the platform as well. This satisfied all of Medicare's requirements for payment, Vathsangam said. The company has already signed three hospital contracts and is aiming to bring in $600,000 in revenue from 10 hospitals in 12 months. Moving Analytics can be reached at movinganalytics@blueprinthealth.org

Limestone Labs is tackling hospital-acquired infections (HAI) with its CleanSlate device. This is a santifizing system that uses ultraviolet technology to disinfect healthcare workers' smartphones and other portable electronics. According to co-founder Taylor Mann, one in four portable devices are contaminated with pathogenic bacteria, and one in 20 patients will contract an infection. This has become a financial issue for hospitals as well, since Medicare can refuse payment to hospitals for the cost of care associated with HAIs. The CleanSlate system, in tandem with software, can also allow for automatic tracking and measure compliance with sanitization rules. Mann explained that the company charges hospitals $175 per month for each CleanSlate system. He noted that CleanSlate can benefit hospital finances, save nurses time, and give infection prevention and control professionals data that can be used to make improvements. According to Mann, CleanSlate is already being used in three pilot hospitals and the company has just recently signed its first purchase order. Limestone Labs can be reached at LimestoneLabs@blueprinthealth.org

Signifikance came out of co-founder Iker Huerga's frustration with the 12 weeks it took for his dad, who was diagnosed with prostate cancer, to receive lab results telling him more about his disease. Huerga, who was previously a senior data scientist at Memorial Sloan Kettering Cancer Center, had first-hand experience with the manual process of matching a patient's genomic data with personalized therapies culled from medical literature. Signifikance's platform can cut this manual undertaking down to a one-hour turnaround. At just $100 per report, this could add up to $1 million in revenue for each genetic lab, Huerga posits. And, with 3500 labs, this equates to a $3.5 billion market opportunity. Huerga said the company has three signed customers and has been growing revenue 50% month over month, from ~$5000 in January to ~$35,000 in April. The goal is to reach a run rate of $1 million by the end of 2015. Signifikance can be reached at signifikance@blueprinthealth.org      

To read more about these and the other startups who presented at Blueprint Health's Demo Day, check out the Winter 2015 Alumni page

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

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

[Top image courtesy of NOKHOOG_BUCHACHON/FREEDIGITALPHOTOS.NET]

Is Apple Watch Giving a Tantalizing Clue of Firm's Interest in Medtech?

Is Apple Watch Giving a Tantalizing Clue of Firm's Interest in Medtech?

Tech experts have done a teardown of the Apple Watch to reveal an unactivated pulse oximeter. What could this mean?

Arundhati Parmar

Last year, Apple met with FDA and hired several medtech talent including biomedical engineers from Vital Connect, Masimo Corp, Sano Intelligence and O2 MedTech.

Those were reported well before the launch of the Apple Watch late last year. Given that context some were disappointed that the Apple Watch, it's heart rate monitor functions aside, would provide simple fitness tracking capabilities as opposed to more robust medical-grade capabilities.

But now comes the revelation that the Apple Watch contains an unactivated pulse oximeter. Here's what the experts at iFixit found:

Apple’s heart rate monitor is actually a plethysmograph that looks and acts like a pulse oximeter, but Apple isn’t claiming it can measure your blood oxygen level. Why? Beats us. But it’s probably FDA regulation related.

Apple is not commenting of course. As a result there are more questions than answers. 

Was the regulatory hurdle too difficult to navigate? Would adding sophisticated sensors to the Apple Watch be a technical challenge?

And indeed a Wall Street Journal article earlier this year noted that Apple abandoned the effort to include medical sensors into its Apple Watch because of the potential for regulatory headaches as well as questions of whether they would drain battery life too quickly.

All of that sounds reasonable, but then why insert an unactivated sensor on a launched device?

The website 9-to5mac.com raises the possibility that Apple is perhaps awaiting FDA approval for its pulse oximetry capabilities. 

"If that turns out to be true, then it’s possible that a software update could later enable the feature for existing first-gen Apple Watch owners," the website posits.

The same website also speculates that the unactivated sensor may not be robust enough yet, which means that future generations of the Apple Watch could have that capability.

This latest revelation comes on the back of the news that besides meeting with FDA, Apple executives have also been talking to insurance companies.

A tableau is beginning to take shape, even though the full picture has yet to materialize. And it is suggesting that Apple wants to play a bigger role in healthcare.

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

[Image Courtesy of Apple] 

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center

10 Causes of Medical Device Failure

1. Insufficient TestingGoing about electrostatic discharge testing (ESD) in the wrong way can be perilous, as a popular YouTube video titled “Don't worry, it's just ESD!” points out.  Not doing any kind of requisite testing for that matter can be problematic, of course.Evidently, HeartWare (Framingham, MA) made that mistake when developing controllers for a clinical trial of its implantable heart pumps. The older controllers, used by about 120 U.S. patients, exhibit a higher susceptibility to electrostatic discharge (ESD) than the company’s newer, commercial controllers.Such an ESD could cause the pump to stop, leading to serious injury or death, the company said. Since a voluntary Field Safety Corrective Action in 2013, HeartWare has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to a pump stop.Continue >>

10 Causes of Medical Device Failure

April 2015

When medical devices fail, the consequences can be tragic. Here are 10 common reasons they do.

Learn more about cutting-edge medical devices at MD&M East, June 14–15, 2016 in New York City.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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Image above inspired by figure from an FDA guidance document.

Could This New Heat Shrink Simplify Catheter Manufacturing?

Zeus claims its new FluoroPEELZ removes some major headaches when it comes to producing catheters.

Nancy Crotti

Zeus FluoroPEELZ
FluoroPEELZ (Image courtesy of Zeus)

A South Carolina company is touting a new heat-shrinkable assembly aid that decreases damage to catheters during manufacturing, reducing waste and the necessity of specialized operator training.

FluoroPEELZ is a fluoropolymer heat shrink from Zeus (Orangeburg, SC) that operators can easily peel rather than cut off from the catheter shaft after the reflow heating process in which the inner layers of the catheter are combined.

Other heat shrinks may have score lines, perforations, or thinned out walls, all of which may increase the likelihood that an operator will damage the catheter assembly under the heat shrink, according to Irina Roof, Ph.D., a material scientist at Zeus.  Nicked or damaged catheters must be discarded, leading to waste, longer production times, and added cost, according to Roof.

The longer the catheter and the smaller the diameter, the greater the risk that damage will occur. The new assembly aid allows for long, continuous lengths of the heat shrink and an easier subsequent removal after the reflow is complete. The material is clear, allowing manufacturers to monitor the reflow process in position, Roof added.

The process also requires sufficient hoop strength to properly reflow and bond materials below the heat shrink, Roof explained.

FluoroPEELZ' compression strength is comparable to traditional fluoropolymer heat shrinks that have been on the market for years, so manufacturers need not vary their process much, she added.

Operator training also becomes more streamlined with the new heat shrink.  Operators can make a small cut in the end of the tube and pull it apart, allowing it to evenly peel from the catheter surface. FluoroPEELZ will benefit makers of neurologic and pediatric catheters, whose small size makes them more prone to damage, according to Roof.

"Removing the heat shrink has become very easy," she said.

Zeus is presently offering the new heat shrink in standard 3-to-18 Fr. sizes, and is in the process of developing smaller and larger ones.

Zeus worked for years to develop a peelable catheter assembly aid, but attacked the problem more intensely in the past year-and-a-half. Identifying the material proved one of the biggest challenges, as well as achieving clarity and compression strength.

"The combination of the material selection as well as processing development is what led us to a successful product," Roof said.

The product, which has Class VI approval,debuted at MD&M West in Anaheim, CA, in February. (Visit Zeus' exhibitor booth at BIOMEDevice Boston, May 6-7, 2015, or MD&M East in New York City, June 9-11, 2015.)

Roof declined to identify competitors in the heat-shrink tubing sector, and which catheter manufacturers have ordered FluoroPEELZ.

"The customers' yields have increased tremendously," she allowed. "You don't have to throw away the entire construction because of a nick."

Nancy Crotti is a contributor to Qmed and MPMN.

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