Medtronic Archives - Page 15 of 59 - Medical Design Sourcing

Medtronic wins CE mark for extravascular defibrillator system

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system.

The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it avoid certain risk with its lead placed outside the heart and veins.

Aurora remains investigational in the U.S. Medtronic plans to make it commercially available in select European countries in autumn 2023.

Patients who receive the Aurora EV-ICD system have defibrillation, anti-tachycardia pacing (ATP) and back-up pacing therapies available through a single implanted device. The device offers similar size, shape and longevity to traditional ICDs, Medtronic said. It also features proprietary procedure implant …

Medtronic faces antitrust lawsuit over surgical devices

The Voyant advanced bipolar system [Image courtesy of Applied Medical Resources]Applied Medical Resources is accusing Medtronic (NYSE:MDT) of using its size to shut down competition in the U.S. market for advanced bipolar devices used to cut tissue and seal blood vessels.

Rancho Santa Margarita, California–based Applied Medical filed an antitrust complaint yesterday in Central California’s U.S. District Court.

“We are proud to be a leader in this competitive and growing space,” a Medtronic spokesperson said in a statement shared with MassDevice. “The claims are baseless and Medtronic will defend against the lawsuit filed by Applied Medical.”

In its lawsuit, Applied Medical said Medtronic has a dominant 78% share of the advanced bipolar device market with its Ligasure device — and it has dominance when it comes to a host of other surgical devices.

The privately held company accused the publicly traded medtech giant of usi…

Apple hires Medtronic Chief Human Resources Officer Carol Surface

Medtronic EVP and Chief Human Resources Officer Carol Surface [Photo courtesy of Medtronic]Medtronic (NYSE:MDT) EVP and Chief Human Resources Officer Carol Surface will become the first chief people officer at Apple (Nasdaq:APPL) in March.

That’s according to Bloomberg, which reported that Apple CEO Tim Cook disclosed the new hire in a memo to employees.

Surface joined Medtronic — the world’s largest medical device company — in 2013 after C-level HR roles at Best Buy and Pepsi.

Related: The biggest medtech personnel moves in 2022

Surface “brings an incredible depth of experience, which will be invaluable in supporting our teams around the world and building on everything that makes Apple so special,” Apple said in a statement.

It’s not clear whether Medtronic has identified a successor for Surface. MassDevice has reached out to the company for more information and will update this story when more details are avail…

Medtronic hit with $106.5M verdict in CoreValve TAVI patent case

Medtronic’s CoreValve Evolut TAVR [Image from Medtronic]Medtronic (NYSE:MDT) must pay $106.5 million in a TAVI patent infringement lawsuit, a federal jury and California ruled this week.

Colibri Heart Valve claimed in 2019 that Medtronic violated its patents for replacement heart valves. The lawsuit alleged infringement of two patents with the Medtronic CoreValve, CoreValve Evolut R, CoreValve Evolut Pro, and CoreValve Evolut Pro+.

CoreValve Evolut transcatheter aortic valve implant (TAVI) products first received FDA approval in 2014. They rival Edwards Lifesciences’ (NYSE:EW) implants, which had the market to themselves for two years before the CoreValve products received the FDA nod.

Edwards and Medtronic reached a $750 million settlement over heart valve implant patents in 2014. Medtronic agreed to pay royalties through April 2022 of at least $40 million annually. Neither company admitted to any infringement as part of the settlement.

…

Medtronic: Linq monitor boosts AFib detection 10-fold among stroke patients

The Reveal Linq implantable cardiac monitor (ICM). [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced clinical data demonstrating significant improvements in AFib detection using the Reveal Linq.

The study compared the Reveal Linq insertable cardiac monitor (ICM) to patients randomized to standard of care. Those patients did not receive continuous long-term monitoring. Medtronic presented the three-year data at the American Stroke Association’s International Stroke Conference (ISC) 2023.

According to a news release, it builds on the 12-month Stroke AF study data published in JAMA in June 2021. The data includes about a 10-fold increase in AFib detection with the Reveal Linq technology.

Reveal Linq detected AFib in 12.5% of patients compared to 1.8% of patients randomized to standard of care. The standard of care techniques included 12-lead ECGs, Holter monitoring, telemetry or event recorders. At three years, the rate of AFib detection …

Biopharma company Chiesi appoints former Medtronic exec as CEO

New Chiesi CEO Giuseppe Accogli. [Image from Baxter India website]

Chiesi announced today that it appointed former Baxter and Medtronic executive Giuseppe Accogli as its new group CEO.

Parma, Italy–based Chiesi said Accogli’s appointment becomes effective April 3, 2023. The R&D-focused pharmaceutical company develops and commercializes products for the hospital, rare disease and adjacent specialty care settings.

Accogli brings 25 years of international experience to Chiesi. The longtime executive leader’s experience includes medtech companies such as Baxter and Medtronic. In addition, his background includes work across multiple disciplines, like sales, marketing, R&D, M&A, strategy and product innovation. In past roles, he focused on the U.S. and EMEA markets.

“I am honored to lead Chiesi into its new stages of growth and I thank the board of directors for their tr…

What to expect in diabetes care in 2023

[Image courtesy of Walmart]

After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, and rumored spinouts and acquisitions.

You can read all about the biggest diabetes stories of 2022 here.

There’s plenty to look forward to in the diabetes space in the months ahead. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time …

The year ahead in diabetes care: what to expect in 2023

[Image courtesy of Walmart] After a banner year for diabetes technology in 2022, there’s still plenty to look forward to in 2023.

Throughout 2022, we saw a wide range of advancements in diabetes technology. We saw launches for next-generation technologies, exciting clinical trial results, rumored spinouts and acquisitions and more.

You can read all about the biggest diabetes stories of 2022 here.

As we embark on a new year in 2023, there’s still plenty to look forward to in the diabetes space. Here are a few things worth keeping an eye on.

CMS decision could benefit CGMs

In October, The Centers for Medicare and Medicaid Services (CMS) published a new local coverage determination (LCD). That LCD modified coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Analysts suggested at the time that the decision marked a win for …

Fresenius Medical Care joins health equity pledge

Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland.

As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective vision of “Zero Health Gaps,” making improvements in health equity.

In total, 39 organizations joined the pledge. Medtronic announced yesterday that it took part. Other medtech companies joining include Henry Schein, Hologic and Philips, according to the World Economic Forum.

Fresenius said its involvement marks a commitment to “meaningful action and collaboration toward health equity.”

“We believe that access to equitable and high-quality health care is a fundamental human right, and we are committed to working with global leaders and organizations to improve the lives of millions of…

January 2023 Issue: The Leadership In Medical Technology Issue

Outset Medical CEO Leslie Trigg and the beginner’s mindset

Move over baby boomers, former Medtronic CEO Bill George says

The biggest medtech personnel moves in 2022

5 tips from medtech leaders for the next generation

How this medtech molder is navigating challenging times

Assurea’s co-founder is on a mission to elevate women in pharma

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Titan Medical shows off Enos surgical robot’s next-gen design

Courage to lead – and leap

It’s been a privilege to edit the latest edition of Medical Design & Outsourcing, kicking off 2023 with our annual Leadership in Medical Technology Issue.

Executive Chris Newmarker had the honor last year, as I was on paternity leave with my newborn son. Baby James is now a fearless 1-year-old on the move, scrambling his way to new heights …

January 2023 Issue: The Leadership In Medical Technology Issue

Outset Medical CEO Leslie Trigg and the beginner’s mindset

Move over baby boomers, former Medtronic CEO Bill George says

The biggest medtech personnel moves in 2022

5 tips from medtech leaders for the next generation

How this medtech molder is navigating challenging times

Assurea’s co-founder is on a mission to elevate women in pharma

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Titan Medical shows off Enos surgical robot’s next-gen design

Courage to lead – and leap

It’s been a privilege to edit the latest edition of Medical Design & Outsourcing, kicking off 2023 with our annual Leadership in Medical Technology Issue.

Executive Chris Newmarker had the honor last year, as I was on paternity leave with my newborn son. Baby James is now a fearless 1-year-old on the move, scrambling his way to new heights …

Medtronic signs pledge to advance health equity

Medtronic (NYSE:MDT) today announced that it joined the Global Health Equity Network (GHEN) to drive change in health equity.

GHEN, a World Economic Forum, brings together the private and public sectors to address health equity issues. CEOs and business leaders comprise the forum focused on prioritizing action in organizational strategy and purpose.

“Addressing health equity is critical because more than half the world’s population lacks access to essential healthcare,” Medtronic said in a news release. “And the most challenging health issues disproportionately impact marginalized populations. But we recognize that no one solution or organization can achieve health equity alone; strategic partnerships are essential to accelerating this critical work.”

As part of the GHEN agenda, Medtronic signed the Zero Health Gaps Pledge. This pledge addresses progress in health equity across 10 areas. Committed organizations agreed to help driv…