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Medtronic HeartWare instructions recall is serious

Medtronic’s HVAD [Image courtesy of Medtronic]Medtronic (NYSE:MDT) is recalling its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal.

FDA today designated the recall as Class I, its most serious level of recall.

The HeartWare ventricular assist device (HVAD) is used as a bridge to heart transplants in patients who are at risk of death from end-stage left ventricular heart failure, to give the heart tissue time to recover, or as a therapy for patients for whom new transplants are not planned.

The reasons for the recall, issued by Medtronic on Feb. 26, are:

A drop of the carrying case, caused by damage to the case or improper wear, can disconnect the driveline and then interrupt pump power. A patient who removes the driveline cover during a controller exchange may put the cover back on backwards. In that position, the fit of the cover causes the dr…

Medtronic Talks Podcast : Mazor, Hugo. What’s next in surgical robotics?

What are Medtronic’s plans in surgical robotics?

In this episode, two of the executives leading Medtronic’s push into robotics surgery update listeners on the progress and potential of Medtronic’s MAZOR X Stealth and Hugo RAS system platforms.

Megan Rosengarten, president of surgical robotics, says HUGO is poised to deliver surgeons newfound capabilities and options. The company hopes to begin selling the system later this year after filing for a CE Mark in Europe and an IDE with the US Food and Drug Administration.

We also speak with Linnea Burman, vice president and general manager, enabling technologies, about Medtronic’s cranial and spinal offerings including the spine surgical robot, Mazor.

Subscribe on all major podcast channels to hear future episodes.

MedtronicTalks · From Mazor to Hugo and beyond: Where does Medtronic see opportunities in robotic surgery

Spine surgeon settles with DOJ for $4.4M in whistleblower case

The U.S. Department of Justice today announced a $4.4 million settlement with spine surgeon Wilson Asfora in a whistleblower case.

According to a news release from the Joseph Greenwald & Laake law firm, which represented the whistleblowers, Asfora settled for the $4.4 million sum and a six-year exclusion from all federal payer programs, effectively precluding him from practicing medicine over that period.

Asfora, a South Dakota neurosurgeon, was alleged to have violated the False Claims Act by two fellow surgeons who filed the complaint as whistleblowers in 2016. The whistleblowers alleged that Asfora sold his own medical devices for surgeries he performed, creating an unlawful economic incentive for him to use (and overuse) his own devices on unsuspecting patients.

Included in the allegations was the claim that Asfora performed medically unnecessary spinal fusion surgeries on a number of patients, leading to the whistleblowers attempting to persuade…

Medtronic wins CE mark approval for Evolut Pro+ TAVI system

Medtronic (NYSE:MDT) announced today that it received CE mark approval for its next-generation Evolut Pro+ TAVI system.

Fridley, Minn.-based Medtronic’s Evolut Pro+ transcatheter aortic valve implantation (TAVI) system is the newest version of the company’s self-expanding, supra-annular Evolut Tavi platform.

The latest edition of the platform includes four valve sizes with an external pericardial tissue wrap for advanced sealing with the largest annular range, according to a news release.

Medtronic said the approval follows an indication expansion for Evolut in Europe that extends to patients with severe aortic stenosis who are at low risk for surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

Evolut Pro+ TAVI’s valve sizes are 23 mm, 26 mm and 29 mm for accessing vessels down to 5 mm, along with the 34 mm system for accessing vessels down to 6 mm. The…

DTW Podcast: Can Proximie bring safer surgery to the wider world? How is Getinge answering call for ventilators?

How did Getinge and Proximie respond to the challenges of the pandemic?

In this week’s podcast senior executives from Getinge and Proximie – two very different sized companies – explain how the COVID-19 pandemic accelerated their business.

In the opening keynote conversation, Eric Honroth, president, Getinge North America, explained how the company more than doubled its production of ventilators in 2020. He also discusses recent FDA clearances for two lines of critical devices.

In our closing keynote, Dr. Nadine Hachach-Haram, CEO and founder of Proximie, says the start-up reached its 2023-24 projected size in just a few months as hospitals and medical device companies sought the ability to collect surgeons to the outside world.

Dr. Hachach-Haram, a reconstructive surgeon, gives a detailed account of how a growing shortage of surgeons convinced her to start a technology company.

She also shares how the technology ultimately restored the life of so…

Hear Episode 1 of the new MedtronicTalks podcast

A year ago, the emerging pandemic brought Medtronic’s respiratory business front-and-center as demands for ventilators shot up to save the lives of thousands of people hit with COVID-19.

In this interview, the first of the MedtronicTalks Podcast Series, Medtronic’s Ariel Mactavish and Dr. John de Csepel detail how Medtronic answered the call in many ways. MacTavish, president of the company’s Respiratory Interventions Operating Unit at Medtronic, said Medtronic quickly realize they couldn’t work alone.

“We scaled as rapidly as possible internally with our own manufacturing facilities, but we also worked with partners to try to expand different areas of by sharing our ventilation IP, allowing others to manufacture it, giving good advice to others, to try to ramp that up,” she says in this interview.

Meanwhile, Dr. Csepel, chief medical officer and vice president of medical affairs of Medtronic’s Americas region, recalled his own experiences in the New Y…

Hear Episode 1 of the new MedtronicTalks Podcast

Hear episode 1 of the MedtronicTalks podcast

A year ago, the emerging pandemic brought Medtronic’s respiratory business front-and-center as demands for ventilators shot up to save the lives of thousands of people hit with COVID-19.

In this interview, the first of the MedtronicTalks Podcast Series, Medtronic’s Ariel Mactavish and Dr. John de Csepel detail how Medtronic answered the call in many ways.

MacTavish, president of the company’s Respiratory Interventions Operating Unit at Medtronic, said Medtronic quickly realize they couldn’t work alone.

“We scaled as rapidly as possible internally with our own manufacturing facilities, but we also worked with partners to try to expand different areas of by sharing our ventilation IP, allowing others to manufacture it, giving good advice to others, to try to ramp that up,” she says in this interview.

Meanwhile, Dr. Csepel, chief medical officer and vice president of medical affairs of Medtronic’s Americas…

Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit

Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit.

Fridley, Minn.-based Medtronic’s catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of malignant lesions in the lung, according to a news release. It can also be used together with the standard of care therapy when indicated.

Get the full story at our sister site, Medical Tubing & Extrusion.

Medtronic, Surgical Theater partner on augmented reality platform for cranial procedures

Medtronic (NYSE:MDT) announced today that it partnered with Surgical Theater to offer an augmented reality platform for cranial procedures.

Fridley, Minn.-based Medtronic will interface its StealthStation S8 surgical navigation system with Surgical Theater’s SyncAR technology in an effort to enable neurosurgeons to use AR in real-time to enhance their visualization during complex cranial procedures, according to a news release.

SyncAR is designed to allow surgeons to visualize brian structures, test virtual surgical tools and plan surgeries before entering the operating room through fighter-jet simulation technology. StealthStation S8 is designed to track surgical instruments and guide the user during procedures through hardware and clinical software with tracking and image dataset merging algorithms.

Integration of SyncAR into the StealthStation S8 cranial solution is set to give surgeons the opportunity to expand the benefits of AR and see a 360°…

DeviceTalks Weekly Podcast – iRhythm CEO Mike Coyle, New Podcast!

In this podcast, iRhythm CEO Mike Coyle discusses his decision to join the digital health leader in January.

Coyle’s had to hit the ground running as iRhythm manages some challenging decisions from regional Medicare payors but he also sees great opportunity for the company’s ZIO platform across the healthcare spectrum.

In this conversation, Coyle discusses

How he came to join the Medtech industry. The potential for its ZIO cardiac monitoring technology How the company is dealing with a disappointing reimbursement How the company will pursue the large asymptomatic market What’s expected to come from the company’s partnership with Verily

We also introduce the newest member of our DeviceTalks Podcast family! Catch an excerpt of the first episode in this week’s podcast. Subscribe to hear future episodes.

Caffeine-fueled Chris Newmarker, executive editor of life sciences at Mass Device, takes a break from earnings week to roll out a powerful #newmark…

The 10 largest orthopedic device companies in the world

[Image from Pixaby]Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

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The 10 largest orthopedic device companies in the world

[Image from Pixaby]

Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the w…