China FDA proposes review process for high-priority medical device registration

By Stewart Eisenhart, Emergo Group

Chinese medical device regulators are seeking comment on a draft proposal for determining which devices qualify for the country’s high-priority review program, and in what order.

The China Food and Drug Administration (CFDA) has targeted domestic Class II devices and imported Class II and III devices in the proposal (link in Chinese); the regulator seeks to establish three review groups for determining which devices qualify for high-priority reviews.

Group 1 devices would include products that are part of China’s National Science and Technology Major Project or the National Key Technologies Research & Design Program. Reviews of Group 1 devices to determine whether they qualify for high-priority registration would take five business days.

Group 2 devices would include the following types of products:

• Devices that diagnose or treat rare disorders and show significant clinical advantages over existing treatments
• Devices that diagnose or treat malignant tumors and show significant clinical advantage
• Devices to diagnose or treat diseases that afflict older populations or children and for which no effective treatment or diagnosis methods currently exist
• Devices that are considered urgently needed and that have no existing predicates available on the Chinese market

The CFDA would convene expert panels on a monthly basis to determine which Group 2 devices qualify for high-priority review and which should undergo normal premarket review.

Group 3 devices would include other products that should be evaluated as high priority.

The CFDA first announced its high-priority review pathway in 2014 as a way to introduce innovative medical technologies into the Chinese market faster than through standard registration. While the high-priority pathway does not necessarily curtail any requirements of the standard CFDA registration process, it may nonetheless speed up review timeframes for qualifying manufacturers.

Emergo consultants in China will provide updates on the CFDA proposal in the near future.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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‘Donnie Brasco’ brother sues Zimmer

A former sales rep for Zimmer Biomet (NYSE:ZBH) – who is the brother of the FBI agent on whom the movie “Donnie Brasco” is based – yesterday filed a $15 million lawsuit accusing the orthopedics giant of firing him for his grand jury testimony against a doctor who was allegedly performing unnecessary knee replacements.

Dominick Pistone, the brother of former FBI legend Joseph Pistone, spent 25 years selling Zimmer products before the company fired him in June 2015, according to the lawsuit. In 2007, Dominick Pistone became aware that an unnamed physician, referred to as “Dr. X” in his complaint, was “performing numerous double knee replacements, well above the average … primarily for financial gain and not in the best interest of the patients,” using the OtisKnee implant then made by OtisMed.

But that device was never approved by the FDA and eventually led to a 2-year prison sentence for OtisMed’s former CEO and an $80 million settlement for Stryker (NYSE:SYK), which acquired OtisMed in 2009.

“Pistone was very upset with what he saw happening to a large number of patients who were being treated by Dr. X, and who were being exposed to the products of OtisMed Corporation. Upon hearing Pistone’s concerns, his brother advised him to report the violations to the FBI,” he claimed in the complaint.

Pistone then took his concerns to the FBI, but declined to pursue the matter after an agent told him his anonymity could not be assured. He then called Zimmer’s internal whistleblower hotline, established as a part of a deferred prosecution agreement reaching in 2007 over alleged off-label marketing (earlier this month, federal prosecutors accused Zimmer of breaking their deal). There was no follow-up from Zimmer, the complaint alleged.

In June 2010 Dr. X joined an unnamed company and continued his practice of allegedly unnecessary knee procedures, Pistone alleged.

“Indeed, a large number of Company Y nurses and surgeons openly discussed Dr. X’s improper practices in the operating room,” according to the suit.

After a series of anonymous letters to a trio of Pennsylvania district attorneys and a newspaper drew no response, Pistone in February 2015 was subpoenaed by 1 of the DAs, for the Keystone State’s Northampton County, to testify before a grand jury about Dr. X’s alleged malfeasance.

After his March 2015 testimony, Pistone alleged, the CEO of Company Y threatened to sue Zimmer over the anonymous letters Pistone had written. Zimmer fired him June 15, 2015, claiming he had”diminished capacity,” and offered him a $200,000 severance deal that included a clawback option if it was discovered that he broke Zimmer’s conduct code, according to the complaint.

“Zimmer fired Pistone because he did exactly what [Zimmer’s code of conduct] indicated he was supposed to do – disclose violations of applicable law and/or Zimmer’s Code of Conduct,” according to the complaint.

Pistone is seeking $5 million in compensatory damages and $10 million in punitive damages.

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MassDevice.com +5 | The top 5 medtech stories for June 28, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Sweden’s Handicare acquires mobility device developer Prism Medical

Prism Medical said today that mobility and technical aid developer Handicare agreed to acquire it for approximately $62 million.

Swedish Handicare, which supplies technical aids for the elderly and physically disabled, will pay $12.50 for each outstanding share of Prism Medical. Read more

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4. Unfazed by Brexit, PureTech launches Sonde voice diagnostics firm

Life sciences incubator PureTech Health, unfazed by the worldwide impact of the U.K.’s vote to leave the European Union, announced its latest venture today: Sonde Health, which aims to use a voice-based technology to diagnose mental and physical ailments.

Based on technology licensed from the Mass. Institute of Technology’s Lincoln Laboratory, Sonde’s device is designed to analyze short vocal samples to screen for conditions based on acoustic changes. Read more

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3. Wright Medical wants retrial in Conserve hip implant loss

Wright Medical wants a federal appeals court to overturn the verdict in the 1st bellwether trial over its Conserve metal-on-metal hip implant, arguing that a new trial is warranted because the jury had 2 bites at the apple.

An Atlanta jury last year awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages. The jury found Nov. 24 that the Conserve device was defective and that Wright failed to adequately warn patients about its risks. Read more

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2. Mannkind taps medtech reps after Sanofi deal fails

Mannkind chief commercial officer Michael Castagna is trying to resuscitate the inhaled insulin maker after its co-marketing agreement with Sanofi was cancelled at the beginning of the year due to disappointing sales. He’s fielding a team of about 70 people to sell the company’s Afrezza insulin inhaler, with about ¹⁄₃ coming from the medical device industry.

“We are looking to build a high energy nimble company that reflects the speed of the medical device industry, articulation of the science from biotech and a relentless focus on helping patients suffering from diabetes,” Castagna told Fortune. Read more

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1. Medtronic launches Beacon HF monitoring service

Medtronic said today it launched its Beacon heart failure management service in the U.S., designed to monitor data from cardiac pacing devices to improve early interventions before heart failure events.

The service, which integrates data from the company’s implantable cardioverter defibrillator and cardiac resynchronization therapy devices, will allow patients to engage in daily health checks to both educate patients about conditions and to collect symptoms and biometrics. Read more

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CorMatrix lands CE Mark for CanGaroo surgical envelope

CorMatrix Cardiovascular said today that it won CE Mark approval in the European Union for its CanGaroo ECM surgical envelope for implanted cardiac devices.

Roswell, Ga.-based CorMatrix won 510(k) clearance from the FDA in August 2014 for the CanGaroo device, which is designed to act as a scaffold to stimulate natural wound healing using CorMatrix’s extra-cellular matrix. The CanGaroo envelope is meant to be used with implanted pacemakers and ICDs.

“With data trending toward increases in the number of implants in Europe, we’re excited to make this device available to the Electrophysiology communities of Europe,” president & COO Andrew Green said in prepared remarks.

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Report: Medtronic files for FDA approval of MiniMed 670G ‘artificial pancreas’

Medtronic (NYSE:MDT) has reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas,” which is designed to automatically track and adjust blood sugar levels in patients with diabetes, and expects the federal safety watchdog to issue a decision within a year.

The device measures blood glucose every 5 minutes to keep patients within their target range, according to Bloomberg. Medtronic’s PMA bid is backed by a 124-patient trial that showed better blood glucose control than with manual testing and insulin administration. The average HbA1c blood sugar level at the start of the trial, 7.4, fell to 6.9 by the end of the study, with 58% of patients achieving that goal, the news service reported. There were no malfunctions, hyper- or hypoglycemic events or hospitalizations, lead investigator Dr. Richard Bergenstal, of Park Nicollet’s International Diabetes Center in Minneapolis, told Bloomberg.

Patients using the MiniMed 670G must still recalibrate the device every 12 hours, change out the glucose sensor weekly and refill the insulin reservoir every 3 days, but that’s still a vast improvement over hourly finger-stick tests.

“The work isn’t gone, but it seems to be a lot less,” Bergenstal said. “Patients are working 24 hours a day now. We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”

“This was them, in their homes, going about their lives,” added Medtronic diabetes chief Francine Kaufman. “There was no remote monitoring. The closed loop is running the train now.”

The device proved so popular with the trial subjects that a group asked the FDA for continued access; the study went into an extended review period with more than 100 volunteers.

“It was totally mind-blowing,” Les Hazelton, who is 1 of the patients who joined the trial extension, told the newswire. “I like being in better control of my body and my disease. The more I know about what’s happening right now, the better I can manage it.”

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Gore touts Viabahn endoprosthesis superiority over PTA in new study

W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months.

The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period.

Results from the study were published in the Journal of Vascular Surgery, Newark, Del.-based Gore said.

“Patients with failing dialysis circuits that are unresponsive to balloon angioplasty are a real problem for physicians. Historically, angioplasty has been a popular treatment option, but our study found its 6-month primary patency rates to be well below the ‘reasonable goal’ of 50% stated by the 2006 K/DOQI Guidelines for Vascular Access. The data shown in the Gore Revise clinical study manuscript makes a compelling argument for Gore Viabahn Endoprosthesis use in those challenging cases,” primary author Dr. Thomas Vesely of St. Louis, Mo.’s Vascular Access Services said in a prepared statement.

Data from the study also indicated a 47% improvement in target lesion primary patency and a 48% improvement in circuit primary patency when compared against PTA alone at 6 months. In elbow placements, data indicated a 72% target lesion primary patency at 6 months and 83% access secondary patency at 24 months.

Median time to target lesion reintervention or graft abandonment with the Viabahn was reportedly 2 times that of PTA alone, and placement of the Viabahn led to 27% fewer interventions at the target lesion and in the dialysis access circuit over 2-years, when compared to PTA.

“The Gore Revise clinical study was the clinical support used to gain the U.S. on-label indication for Gore Viabahn endoprosthesis in AV access. By expanding indications to include AV access, Gore Viabahn endoprosthesis continues to show how physicians can depend on the device for complete coverage in complex cases,” Gore peripheral interventional biz leader Ray Swinney said in a press release.

Last December, Gore said it launched a post-approval study of its Viabahn stent graft. The 108-patient Reline Max study will examine the treatment of in-stent restenosis in the superficial femoral artery using the Viabahn device, which is designed to inhibit blood clots with its heparin coating.

The Viabahn stent graft, which 1st won FDA approval in 2005, was approved by the safety watchdog for treating in-stent restenosis last year.

The Reline Max trial’s primary safety endpoint is procedure- and device-related serious adverse events at 30 days, according to ClinicalTrials.gov, and the primary efficacy endpoint is primary patency without repeat intervention after a year. The trial, estimated to be complete in November 2020, is slated for final data collection in November 2018.

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Insurer launches trial of Avinger’s Pantheris atherectomy device

Avinger (NSDQ:AVGR) said yesterday that it is collaborating with health insurers Highmark Health and Allegheny Health Network to launch a trial of its Pantheris image-guided atherectomy device designed for treating peripheral artery disease.

The Pantheris device is designed to use optical coherence tomography to allow physicians to visualize the vessel and obstruction during atherectomy procedures to treat peripheral artery disease.

“Using this technology, we now have the ability to clearly see our way through the artery. This means there is less risk of damaging the artery walls, which can lead to an aggressive healing-and-scarring process that increases the risk of restenosis, or a re-narrowing of the artery after treatment,” Allegheny Health Network vascular surgery director Dr. Satish Muluk said in prepared remarks.

The partnership, and the study, are part of Highmark Health’s “verification of innovation by testing, analysis and learning” – known as Vital – innovation program, Avinger said. The program plans to evaluate the Pantheris device in terms of benefits to patients, providers and payers through the “holistic” evaluation of patient care, the company said.

“PAD is not an isolated problem. It is part of a disease spectrum that often involves diabetes, high blood pressure, cardiac abnormalities and renal insufficiencies. Accordingly, optimal PAD therapy should aim to understand, treat and improve both local and systemic disease effects. By linking delivered care with claims data in a collaborative environment, Vital is changing the conversation about episodic care and redefining what quality means,” Avinger CMO Dr. Arjun Desai said in a press release.

The Vital study will evaluate PAD patients treated with both the Ocelot and Pantheris lumivascular catheter devices, with acute and long-term outcomes compared against a historic cohort of both endovascular and surgical therapies, Avinger said.

A follow-up study will include claims data analysis investigating the evolution of the patient and related co-morbidities during the post-treatment period, the company said.

“Vital’s mission is to support bringing safe, innovative technologies to members and patients that increase quality of care and lead to better patient outcomes without undue financial burden. As one of the largest integrated health care delivery and financing systems in the nation, we embrace our responsibility to accelerate the pace with which novel technologies and services are made available to the public,” Highmark Health CEO David Holmberg said in a prepared statement.

In March, Avinger launched a new version of its Pantheris peripheral atherectomy device and registered for the sale of up to $50 million worth of its stock.

Redwood City, Calif.-based Avinger said the deal with Cowen & Co. doesn’t oblige it to sell any shares. Earlier in March, the company said it would immediately launch an enhanced version of the Pantheris device after winning FDA clearance. Pantheris won its 1st nod from the agency in October 2015; Avinger said the new version features improved ergonomics, physician controls and manufacturability.

Avinger floated a $65 million initial public offering in January 2015. Last September the company pulled in a $55 million term loan.

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