Medtronic Archives - Page 44 of 59 - Medical Design Sourcing

5 of the latest cardiac tech insights out of ACC.21

The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech.

Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology showed significant progress in reducing high blood pressure.

Get the full story on our sister site, Medical Design & Outsourcing.

ReCor Medical has positive renal denervation study news

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Get the full story on our sister site MassDevice.

ReCor Medical has positive renal denervation study news

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Medtronic, though, has since sought trial designs that…

DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing

In this week’s episode of the DeviceTalks Weekly Podcast, Jeff Mirviss, executive vice president of Boston Scientific’s peripheral business, explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” that his business group is addressing.

Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business.

He also shares lessons learned over his 20-plus years at Boston Scientific including the challenges presented by the Guidant acquisition and the necessary spirit infused by CEO Michael Mahoney.

Also on this week’s podcast, Eric Kolodziej, corporate vice president and global head quality and regulatory affairs at Hologic, about how clinical trial management is changing. What role will real world evidence play going forward, and how will Hologic and others follow up on the record number of EUA’s issued over the past yea…

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.