CMS opens NCA to reconsider TAVR coverage

The Centers for Medicare and Medicaid have opened a National Coverage Analysis looking to reconsider its National Coverage Determination for transcatheter aortic valve replacement procedures.

Medicare’s NCD for TAVR was established in 2012 with strict criteria for reimbursement and procedure performance that limited TAVR to high-volume hospitals and medical centers.

Requirements in the 2012 decision included specific procedural volume requirements for heart teams and hospitals’ as well as mandatory participation in a registry.

In a letter requesting reconsideration of the decision, Providence Health & Services of Southern California’s Dr. Peter Pelikan, Dr. Richard Wright and Dr. John Robertson said that since 2012, TAVR procedures have become more standard and safer, and urged for reconsideration of coverage.

The doctors said that initial approval of TAVR hospital programs were based on volumes of non-TAVR procedures, and that procedural volume was used “as a surrogate for program quality,” which was understandable given the novel nature of the procedure.

“Today, TAVR has become a commonplace and safe procedure, with indications now expanded from high risk to intermediate risk patients as well. Procedural volumes across the country are increasing, with excellent outcomes. Thus, the early motivation for the NCD, insuring quality for a new and high risk procedure, is no longer relevant,” Providence Health & Services authors wrote in their letter.

Medtech dev Edwards Lifesciences (NYSE:EW), maker of the Centera and Sapien lines of TAVR devices, also showed support for the reconsideration and urged CMS to expand availability to reach more patients.

“As we move forward, our priority will be on assuring that the NCD provides all people with heart valve disease with access to all treatment options, enabling patients to choose the right treatment at the right time. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important policy, which will define the future of heart valve patients’ access to this life-saving care,” Edwards wrote in a press release.

CMS said that on July 25, it will convene a panel of its Medicare Evidence Development & Coverage Advisory Committee seeking its recommendations “regarding the evidence on procedural volume requirements for hospitals and heart team members” necessary to launch and maintain TAVR programs.

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FDA labels Medtronic Heartware recall as Class I

The FDA last Friday labeled a Medtronic (NYSE:MDT) voluntary select recall of its HeartWare HVAD systems over issues with unexpected power source switching as a Class I recall.

A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death.

The devices are being recalled over possible interruptions in the electrical connection between power sources, including batteries, adapters and the HVAD controller, which could cause disconnection and result in possible pump stoppage.

A pump stop event could cause issues including exacerbation of heart failure symptoms and other symptoms including mild weakness, dizziness, anxiety, nausea, loss of consciousness or death, according to an FDA release.

The interruption to the electrical system is caused by oxidation of the connecting surfaces between the power source connector and the controller’s power source socket, the FDA said.

The recall affects a total of 204,017 Medtronic devices, including the HeartWare device and accessories, manufactured and distributed between March 2006 and May 2018, according to an FDA notice.

The recall affects HeartWare controllers and controller kits with model numbers 1400, 1401, 1403, 1407 and 1420, HeartWare DC adapters with model numbers 1435 and 1440, AC Adapters with model numbers 1425 and 1430 and battery packs with model numbers 1650.

Medtronic said that the recall affects 16,399 implanted HeartWare HVAD devices as of May 22, and clarified that there have been no reports of serious harm related to the recall, calculating the per-patient probability of serious adverse events at approximately 0.003.

The Fridley, Minn.-based medtech giant began notifying clinicians of the issue last month, warning that the power disconnection could cause unexpected beeping which could confuse the patient or caregiver, as the unit’s controller may still display sufficient battery capacity or AC/DC connectivity while the beeping is active.

Medtronic suggested that clinicians managing HeartWare devices reiterate the importance of having two power sources connected at all times, to reinforce best practice guidance for managing power sources when going to sleep and awakening and instructing patients to report any unexpected audible tones.

Late last month, Medtronic said it made a lubricant solution designed to be applied to the HeartWare HVAD system’s power source connectors as a method for mitigating unexpected transient power switching, which will be distributed to Medtronic HearWare field reps, according to a press release.

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EuroPCR 2018 Roundup: Edwards reportedly pauses Centera valve EU launch

Edwards Lifesciences’ (NYSE:EW) European launch of its Centera valve has been temporarily paused as the company looks to modify the device’s delivery system, according to a Leerink Partner letter to investors highlighting presentations from the EuroPCR 2018 Annual Meeting.

Delivery of the unit and its use in clinical cases are slated to resume during the third quarter, according to the letter, with Edwards claiming there will be no impact on its financial guidance for the year.

The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Irvine, Calif.-based company said.

The Centera valve won CE Mark approval in the European Union with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery in February.

Leerink Partner analysts noted that despite the expected return, “our checks indicate that EU physicians are resistant to the price premium EW is seeking for Centera, which dampened enthusiasm for adoption once the launch does resume.”

“For EW, both physicians we spoke with noted that Centera was too cost prohibitive and – despite the interventional cardiologist having been part fo the trial – neither would adopt it at their centers,” Leerink analysts wrote in their letter to investors.

Edwards has not yet publicly released information on the pause outside of the EuroPCR meeting.

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Investors win class certification in lawsuit against Abbott’s Thoratec

A group of Thoratec shareholders this week won a class certification in a revived suit claiming that Thoratec, now owned by Abbott (NYSE:ABT), and some of its officers hid facts about its HeartMate II heart pump’s rate of thrombosis that would have negatively affected share prices, thereby misleading investors.

Investor Bradley Cooper originally brought the suit against the company in January 2014, on behalf of anyone who bought stock between April 29, 2010, and Nov. 27, 2013. Plaintiffs in the case argued that the company failed to warn investors about a blood clot problem with its HeartMate II implant implicated in a Class I recall.

In 2013, the FDA said an improperly connected component in the implant may result in deformation or tearing of the device’s outflow conduit, putting the patient at risk of serious injury or death. A year before that, a study published in the New England Journal of Medicine showed a sharp increase in the rate of blood clots with the HeartMate II LVAD.

The Pleasanton, Calif.-based device maker issued a correction notice in February 2012, warning physicians that a small portion of the HeartMate II devices’ sealed outflow graft bend reliefs, designed to prevent a connector between the pump and the aorta from kinking, were not properly connected.

“Thoratec hid from its investors its own internal data confirming such reports and the related financial risk, and did not correct its prior disclosures. […] Thoratec did not disclose the extent of the impact that the reported increases had on HeartMate II’s commercial viability until August 6, 2014, causing its stock to drop some twenty-five percent,” according to court documents.

The suit was revived last October by a Ninth Circuit panel which decided it was a mistake that a lower court dismissed the case, and that investors had sufficient grounds for their claims that the company misled them.

The case now includes both Bradley Cooper and Todd Labak as plaintiffs, who both purchased shares in July and August 2013. Plaintiffs in the case were found to meet the appropriate rules for class certification, US District Judge Claudia Wilken ruled this week, according to court documents.

Abbott acquired Thoratec when it bought St. Jude Medical last year. Last May, Abbott recalled nearly 29,000 controllers for the HeartMate II implantable heart pump after 26 patients died trying to change out the controllers on their own.

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Abbott warns of outflow graft twisting issues with HeartMate 3

Abbott (NYSE:ABT) last Friday warned about possible issues with its HeartMate 3 left ventricular assist device over possible twisting of the outflow graft that can occur post-implant and could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood flow or clotting.

The Abbott Park, Ill.-based company is not recalling any such devices from patients or hospitals, but said it has received 32 reports of such twisting amongst the 4,467 HeartMate 3 devices implanted worldwide.

Reports include issues related to low blood flow, clotting and three deaths that could be linked to outflow graft twisting, Abbott said.

The company reported that it has begun contacting physicians and patients implanted with the HeartMate 3 in the event that they receive reports of persistent low flow alarms that could indicate such twisting.

Abbott said it has also notified the appropriate regulatory bodies of the issue, as well as implanting physicians to try and monitor and prevent future issues related to twisting, according to a press release.

Abbott won FDA approval for the HeartMate 3 implantable heart pump last August, cleared for patients awaiting a transplant.

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Abbott wins Japanese reimbursement nod for MitraClip

Abbott (NYSE:ABT) said today that it logged a reimbursement win in Japan for its MitraClip device for treating mitral valve regurgitation.

The Chicago-area medtech giant said Japan’s Ministry of Health, Labor & Welfare granted national reimbursement for MitraClip, effective April 1. The MHLW approved the device last November for treating severe degenerative mitral regurgitation functional mitral regurgitation.

“Our mission is to develop technologies and therapies that help people return to better health and quality-of-life as quickly as possible,” structural heart VP Michael Dale said in prepared remarks. “With this reimbursement in Japan, we can help more people live better by reducing the severity of an extremely life-altering illness in a safe and predictable way.”

MitraClip won pre-market approval from the FDA in October 2013.

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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Abbott wins FDA nod for pediatric Masters Series mechanical heart valve

Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world.

The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or mitral position and consists of two semi-circular discs that open and close in response to blood pressure changes during the heart beat, according to an FDA release.

The newly approved 15mm version of the device clears the valve for use in pediatric patients who previously had no options, the FDA said.

The agency claims that more than 35,000 babies are born in the US each year with congenital heart defects, many of which will require replacement heart valves that, prior to the approval, were not available.

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said in a press release.

Approval came based off clinical data from a single-arm study of 20 pediatric patients, between the ages of 1.5 weeks and 27 months, with serious heart failure in which the device was used as a mitral valve replacement.

Data from the study showed that one year post-implant, survival rates were 69.3% while the rate of freedom from valve-related adverse events was 66.8%, according to the FDA release.

Serious adverse valve-related events noted during the study include blood clots in the device and brain bleeds. The FDA said that anticoagulation therapy may be required to help prevent device clotting.

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Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues

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Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio.

Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report.

A single patient was reported to have experienced a complication caused by a battery malfunction, which culminated in a battery advisory that was sent to doctors and the redevelopment of battery components, Healio reports.

A total of 33 patients were followed for up to 38 months in the Leadless trial, with a single patient unable to receive the Nanostim device due to a problem.

Survival at three years was reported at 74%, with no deaths reported as being related to the device, according to the report.

The rate of freedom from serious adverse events was reported at 89.9% at 40 months, with three patients experiencing device-related complications, according to Healio.

One patient had a reported procedure-related perforation leading to cardiac tamponade, another had an inadvertent placement of the device through a patent foramen oval leading to removal and re-implantation, while the last had a battery malfunction at 37 months that caused loss of communication, with the device being removed and replaced, according to the report.

No incidents of late device dislodgements, device infections or pacemaker syndrome were reported, and at three years electrical performance of the device was reported as being adequate, Healio reports.

“The overall [leadless cardiac pacemaker] complication rate of 10.1% is comparable to previous reports of transvenous pacemaker complications. Development of a new battery should resolve [the battery malfunction] issue. The adequate performance and freedom from [serious adverse device effects] at midterm follow-up in this first-in-humans patient cohort support the use of leadless pacing as an alternative to transvenous pacing, especially considering the promise of decreasing long-term pacemaker complications,” study author Dr. Fleur Tjong of Amsterdam’s AMC Heart Center said, according to the report.

Medtronic wins FDA nod for Azure remote monitoring equipped pacers

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Medtronic logoMedtronic (NYSE:MDT) said today it won FDA approval for its portfolio of Azure pacemakers with BlueSync patient monitoring technology.

The clearances cover both the Azure XT MRI and Azure S MRI pacers including single chamber and dual chamber models, the Fridley, Minn.-based company said. The newly cleared pacers have estimated lifespans of 13.7 years for dual chamber pacers, which Medtronic estimates is 27% longer than the earlier-gen devices.

The Azure portfolio of pacers feature the company’s BlueSynch technology which allows for automatic remote monitoring through the company’s CareLink network, and its Azure XT device features the Reactive ATP algorithm intended to slow the progression of atrial fibrillation.

“With the approval of Azure, clinicians managing patients with bradycardia now have pacemakers with improved longevity, and better ability to detect and reduce atrial fibrillation. BlueSync technology with Azure also enables secure and automatic wireless data transmission to clinicians. Remote monitoring with automatic data transmissions can result in earlier clinical decisions and improved patient monitoring compliance,” cardiac rhythm & heart failure division prez Dr. John Liddicoat said in a press release.

Medtronic said that in connection with the approval, its Percepta line of cardiac resynchronization therapy pacers now include BlueSync tech for remote monitoring through the CareLink network.

Earlier this month, Medtronic released its preliminary second quarter earnings, estimating the impact of Hurricane Maria at approximately $55 to $65 million, or 3¢ on its second quarter non-GAAP earnings per share.