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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Abbott releases cybersecurity, battery update for high-voltage implantable cardiac devices

Abbott (NYSE:ABT) today announced a firmware upgrade for its high-voltage implantable cardiac devices looking to shore up cybersecurity and improve battery performance.

The company stated that while the update is intended to improve cybersecurity through an additional layer of protection against unauthorized device access, it has not received any reports that any of its devices have been exploited remotely. Abbott also said that it has not identified any new vulnerabilities in its cardiac device portfolio.

The newly released firmware upgrade includes an enhanced device-based battery performance alert, Abbott said, which aims to improve battery performance management with certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

The battery update will allow for the monitoring of abnormal battery behavior and will vibrate to alert patients if abnormal behavior is detected. Abbott said the capability was previously limited to its Merlin.net remote monitoring systems.

Abbott began the series of updates last year with a focus on pacemaker devices it acquired when it paid $25 billion for St. Jude Medical.

The initial improvements came after St. Jude warned in late 2016 of battery issues that could disable high-voltage cardiac rhythm management devices, with two deaths reported in relation to the issue. Those warnings followed a short-seller-fueled scandal about alleged cybersecurity vulnerabilities in the St. Jude devices.

Short-selling firm Muddy Waters and a cybersecurity firm in August 2016 alleged that major flaws in the CRM devices exposed them to a cybersecurity risk, but only after taking short positions on STJ’s stock. St. Jude later sued Muddy Waters and the hacking shop behind the report, after the sides traded accusations about its accuracy (which independent researchers found had “major flaws” – but not before STJ shares lost about 5% of their value).


Abbott said it is communicating with regulatory authorities to implement the upgrades, which will be available over the next several weeks. The company went on to recommend that all eligible patients should pursue the upgrades.

The cybersecurity update applies to the company’s Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse systems, while the battery update applies to Fortfiy, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices manufactured between January 2010 and May 2015.

“Technology and its security are always evolving, and this firmware upgrade is part of our commitment to ensuring our products include the latest advancements and protections for patients,” Abbott medical devices exec VP Robert Ford said in a press release.

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Medtronic’s HeartWare can’t slip investors class action over failed MVAD trial

A federal judge in New York City last week shot down a bid by Medtronic subsidiary HeartWare to dismiss a class-action lawsuit brought over a failed trial of its MVAD implantable heart pump.

Framingham, Mass.-based HeartWare in July 2015 launched a clinical trial aimed at winning CE Mark approval in the European Union for the next-generation MVAD pump, but hit the pause button in September 2015 after running into an issue with the manufacturing process for the device’s controller. The problems persisted into January of the following year, when the company said it couldn’t predict when it would be able to get the MVAD program back on line.

That prompted the class-action suit by lead plaintiff the St. Paul Teachers’ Retirement Fund Assn., alleging that HeartWare and then-CEO Douglas Godshall “failed to heed directives by the U.S. Food & Drug Administration to remedy dangerous deficiencies in its processes for manufacturing and testing its devices,” according to the amended complaint.

“Instead, HeartWare disregarded serious defects in MVAD and implanted the flawed device in patients enrolled in a pivotal clinical trial. Defendants nevertheless stated that the company fixed the defects found by the FDA and repeatedly emphasized MVAD’s purported commercial value, superior safety profile and cutting edge technological enhancements. None of these statements were true. As a direct result of this misconduct, HeartWare’s clinical trial of MVAD ended in disaster, with nearly half the patients experiencing serious adverse side effects, and the company’s stock price losing more than two-thirds of its value.”

HeartWare, which was acquired for $1.1 billion by Medtronic in August 2016, moved to dismiss the case, arguing that “optimism does not become securities fraud when the hope wanes” after a failed clinical trial.

The lawsuit, “brought in the wake of a disappointing development in a clinical trial for a new medical technology” is based “entirely on implausible and impermissible hindsight inferences that plaintiff asks the court to draw from the trial results,” according to the motion to dismiss.

“Plaintiff asks the court to infer, for example, that HeartWare and its CEO, Douglas Godshall, were misleading investors when, throughout the class period, they updated investors on when they expected to complete remediation of certain documentation issues identified by the FDA, when they expected initiation of clinical trials for their development-stage medical technology, and how well the new technology was performing in lab and in animal testing. Plaintiff also asks the court to infer that the company and Godshall rushed the new technology into a clinical trial that they supposedly knew was doomed to fail, all the while allegedly misleading investors about the prospects for success. These hindsight inferences make no sense,” the company alleged in the motion.

But Judge Ronnie Abrams of the U.S. District Court for Southern New York ruled from the bench last week that evidence from six former HeartWare employees, who said the problems with the MVAD device were know to the company, was plausible enough to warrant a trial.

Abrams gave the defendants until May 16 to respond to the lawsuit, according to court documents.

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


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.

7 medtech stories we missed this week: Jan. 19, 2018

missed medtech aug 4

[Image from unsplash.com]

From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Privi Medical wins FDA nod for hemorrhoid device

Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news release. The device is disposable and uses an advanced instant cold compression technology to treat hemorrhoids.

2. Centric Medical gets FDA 510(k) clearance for foot & ankle screws

Centric Medical announced in a Jan. 16 news release that it has received FDA 510(k) marketing clearance for its Cannulated Screw Internal Fixation System. The system features foot and ankle screws that can be used in foot and ankle reconstruction procedures. It is a multi-component system made of titanium alloy that comes in a variety of diameters and lengths.

3. BioPoly receives CE Mark for knee implants

BioPoly has received CE Mark for its RS Partial Resurfacing Trochlea system, according to a Jan. 16 news release. The partial resurfacing knee portfolio can treat focal cartilage defects in femoral condyles, trochlear facts, trochlear groove and patella. The company plans to launch the system in the next few months.

4. Avacen launches dry-heat therapy autism device in India

Avacen announced in a Jan. 17 press release that it has launched its Avacen 100 dry-heat therapy autism device in India. The device is an FDA-cleared, CE Mark Class II therapy device designed to provide relief of autistic behavior. Avancen 100 safely and non invasively warms the body by infusing heat into the circulatory system. The device has been shown to improve speech impediments, increase classroom participation and an improvement of school grades.

5. FDA approves Zoll Medical’s full AED line

Zoll Medical has received premarket approval from the FDA to market and distribute its full line of defibrillators in the U.S., according to a Jan. 9 press release. The company’s R Series, X Series, AED Pro and AED Plus have all received premarket approval. Each device uses Zoll’s rectilinear biphasic waveform to deliver maximum current to high-impedance patients.

6. Sealantis wins CE Mark for surgical sealant

Sealantis announced that it has received CE Mark for its Seal-G surgical sealant, according to a Jan. 12 press release. The sealant is designed to reduce leaks after gastrointestinal procedures. Seal-G stops anastomotic leaks by reinforcing suture or staple lines during post-surgery. The sealant will be available in Europe as it has not yet received FDA approval.

7. OrthoXel wins FDA nod, CE Mark for Apex tibial nailing device

OrthoXel announced in a Jan. 16 press release that it has received FDA 510(k) clearance and CE Mark approval for its Apex Tibial Nailing System. The company can now commercialize the system in the U.S. and Europe. The device allows surgeons to have a wide range of locking options of intramedullary nail. Its micromotion locking mode allows for controlled axial movement with torsional stability.

Medical device companies: These 15 performed the best in 2017

[Image from Unsplash]

Updated Jan. 5, 2018

Among the most successful medical device companies of 2017, there were two themes: innovation and breadth of services.

That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world.

What does innovation mean? Think Align Technologies (Nasdaq:ALGN) and how it brought 3D printing to bear on a dental product screaming for better customization: braces. Or there’s Abiomed (Nasdaq:ABMD) and its tiny Impella heart pump, which is meant to help restore blood flow and allow the heart to rest after a heart attack.

For breadth of services, look no farther than Integer (NYSE: ITGR). Created out of the 2015 merger of Greatbatch and Lake Region Medical, Integer is a giant medical device contract manufacturer that could theoretically do almost anything for an OEM.

Most – about four-fifths – of the world’s 100 largest medical device companies saw their stock price increase this year. But Align, Abiomed, Integer and other top companies enjoyed an especially exceptional performance.

Here are the 15 best-performing medical device stocks of 2017, ranked by their stock growth percentage.


And click here to download a performance spreadsheet of the 100 stocks>>

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Maquet opens a new front in patent war with Abiomed


Abiomed, MaquetGetinge (PINK:GETI B) subsidiary Maquet opened a new front last week in its patent war with Abiomed (NSDQ:ABMD), alleging infringement of a patent granted earlier this year.

Danvers, Mass.-based Abiomed sued Maquet in May 2016, asking Judge Dennis Saylor of the U.S. District Court for Massachusetts for a judgment of non-infringement of a trio of patents; counter-suits later brought the number of disputed patents to six.

Last week Maquet added the latest piece of intellectual property to the case, alleging that Abiomed infringes U.S. patent no. 9,597,437, covering a  “Guidable Intravascular Blood Pump and Related Methods.” Maquet alleged that Abiomed’s Impella 2.5, the Impella 5.0, and the Impella CP infringe at least two claims of the patent, which was granted March 21, according to court documents.

Abiomed asked the patent office for a quartet of inter partes reviews of the ‘437 patent, according to the documents, but the Patent Trial & Appeals Board denied two of the petitions Oct. 18.

Maquet is seeking judgments of basic, induced, contributory and willful infringement, plus preliminary and permanent injunctions barring further alleged infringement, basic and triple willfulness damages and royalties. The company also wants Saylor to force Abiomed to cover its legal costs and to grant pre- and post-judgment interest, according to a Nov. 20 court filing.

Medtronic wins FDA nod for Azure remote monitoring equipped pacers


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.

Physio-Control recalls Cardinal Health-made pediatric AED electrodes


Physio-Control, Cardinal Health

Physio-Control said today it launched a voluntary recall of pediatric defibrillation electrodes, made by Cardinal Health (NYSE:CAH), which are components in a number of the company’s Lifepak automated external defibrillators over issues with incorrect art that could lead to misuse.

Redmond, Wash.-based Physio-Control said that artwork on the recalled defibrillation electrodes shows incorrect electrode placement for an infant that could lead to ineffective energy delivery to the patient and serious injury or death.

The recall affects approximately 14,200 electrodes used with the company’s Lifepak Express AED, Lifepak CR Plus AED, Lifepak 1000 defibrillator and Lifepak 500 Biphasic AEDs with pink connectors. Adult defibrillation leads were not affected by the recall, according to a press release.

Physio-Control said it is reaching out to customers to inform them of the issue and is providing correct instructions to be used with the affected AEDs until corrected electrodes are distributed. The company said that if customers decide not to use the electrodes, they can “consider the use of adult defibrillation electrodes until they receive their replacement set of infant/child defibrillation electrodes.”

The company advised customers to report any malfunctions or adverse events to it and the FDA.

In April, Physio-Control won a $28.3 million contract with the US Dept. of Defense for “medical equipment, maintenance of medical equipment, and/or spare parts for medical equipment.”