Medtronic Archives - Page 23 of 59 - Medical Design Sourcing

Medtronic warns on some Cobalt and Chrome ICDs

Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe to warn of issues with some implantable cardioverter defibrillators (ICDs).

The medtech giant warned healthcare professionals that there is the potential for reduced shock energy — around 79% of programmed energy — during high-voltage (HV) therapy for all Cobalt and Crome ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds).

According to the notice, through June 3, 2022, Medtronic identified 27 devices (comprising 0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (SCP) alert. No reports of permanent harm or death have been reported in relation to the issue and Medtronic has submitted a device software update to address the issue. It expects the update to be available for download into implanted devices beginning in the third or fourth quarter of calendar year 2022, pending regulatory approvals.<…

Medtronic partners with CathWorks with option to acquire down the line

Medtronic (NYSE:MDT) announced today that it entered into a strategic partnership with coronary artery disease (CAD) technology developer CathWorks.

Under the agreement, Medtronic will invest up to $75 million and immediately begin co-promotion for CathWorks’ FFRangio system in the U.S. Europe and Japan, where it is commercially available. A separate agreement offers Medtronic the option to acquire CathWorks once certain undisclosed milestones are met.

According to a news release, CathWorks also has the right to compel Medtronic to acquire the company if Medtronic does not exercise the option, which expires in July of 2027 with an estimated value of up to $585 million and potential undisclosed earn-out payments post-acquisition.

Medtronic has held a minority investment in CathWorks since 2018. It expects the co-promotion agreement to be neutral to its fiscal 2023 GAAP and adjusted earnings per share and neutral-to-accretive thereafter.

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Former Mazor VP accused of insider trading around Medtronic acquisition

[Image from Unsplash]A former Mazor Robotics VP is among three businessmen facing federal insider trading charges and an SEC lawsuit over stock trades leading up to Medtronic’s $1.6 billion acquisition announcement in 2018.

Ron Tavlin was Mazor’s VP of business development from 2017 to 2019. Before that, he’d been a paid consultant for Medtronic. The U.S. Attorney’s Office in Minnesota and the SEC claim that Tavlin tipped off his friend Afshin Farahan about the impending deal in 2018, and that Farahan then bought Mazor stock and tipped off friend David Gantman to buy more Mazor stock as well as call options.

Farahan and Gantman made a profit of about $500,000 off the allegedly illegal trades, according to authorities. More than a year late, Farahan gave Tavlin a $25,000 check.

Federal prosecutors also claim that when the Financial Industry Regulatory Authority (FINRA) reached out to Tavlin after the trades with a list of people and e…

July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

FDA can’t explain drop in device recalls, but experts point to COVID disruptions

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “star…

Orchestra BioMed to go public, partner with Medtronic on cardiac neuromodulation therapy

Orchestra BioMed today announced a slew of agreements, including a strategic collaboration with Medtronic (NYSE:MDT).

The global strategic collaboration will progress the development of Orchestra BioMed’s BackBeat Cardiac Neuromodulation Therapy (CNT) as a potential treatment for hypertension in patients who are indicated for a cardiac pacemaker.

Additionally, Orchestra BioMed closed a $110 million Series D financing, which included investments from Medtronic, funds managed by RTW Investments, LP (“RTW”), Perceptive Advisors, Terumo Corporation (“Terumo”), SternAegis Ventures and other investors.

Finally, the company entered into a definitive business combination agreement with HSAC2. The deal is structured to provide a minimum of $70 million in gross proceeds to the combined company at closing and up to $160 million in the event of no redemptions by HSAC shareholders, according to a news release. The Series D financing was not contingent on the co…

Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future

Greg Smith is Medtronic’s EVP of global operations and supply chain [Photo courtesy of Medtronic]

All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers.

EVP of Global Operations and Supply Chain Greg Smith sees fewer suppliers in Medtronic’s future, he said in an interview this week.

Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published interview since joining Medtronic (NYSE:MDT) in April 2021.

Smith was previously EVP of U.S. supply chain at Walmart and SVP of global operations at Goodyear Tire & Rubber Co. His more than three decades of experience also includes time at ConAgra Foods, United Signature Foods, VDK Frozen Foods and Quaker Oats.

Around the same time that he joined Medtronic, semiconductors and resins were in short supply following the February 2021 cold s…

Acutus completes first closing in left-heart access portfolio sale to Medtronic

Acutus Medical (Nasdaq:AFIB) announced today that it completed the first of two closings in its portfolio sale to Medtronic (NYSE:MDT).

Carlsbad, California-based Acutus announced in April that it entered into a definitive agreement to sell its left-heart access portfolio to Medtronic for $50 million. The company’s left-heart access portfolio includes its AcQCross line of sheath-compatible septal crossing devices, AcQGuide Mini integrated crossing device and sheath, AcQGuide Flex steerable introducer with transseptal dilator and needle and the AcQGuide Vue steerable sheath.

According to a news release, Acutus completed the first closing of the sale yesterday, with Medtronic paying the cash consideration of $50 million at the closing. Acutus will be eligible to receive contingent consideration payments of up to $37 million associated with certain manufacturing and regulatory milestones.

In addition to those payments, Acutus is eligible to receive up…

How medical device makers companies are responding to abortion bans

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access.

Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately.

Some medtech companies are not using the word “abortion” in their statements to news media.

Here is what we’re finding out at MassDevice and Medical Design & Outsourcing:

Medtronic

“As a healthcare company, we are committed to ensuring access to quality healthcare, and that starts first and foremost with our people. We are expanding our benefits policies to enable access to critical healthcare services for our U.S. employees. The new benefit will allow for reimbursement of travel, relocation, and legal expenses and …

Medtronic appoints Pfizer EVP as independent board director

Lidia Fonseca is EVP and chief digital and technology officer at Pfizer [Image courtesy of Fonseca]

Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director.

Fonseca, who serves as EVP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee.

Get the full story on our sister site MassDevice.

Medtronic appoints Lidia Fonseca as independent board director

Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director.

Fonseca, who serves as VP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee.

“We are thrilled to welcome Lidia to Medtronic’s board of directors,” Medtronic Chair and CEO Geoff Marth said in a news release. “She has an impressive history of developing digital healthcare solutions that deliver powerful insights to improve patients’ lives. Her extensive knowledge and expertise will provide the Board with an important dimension and a tremendously valuable perspective as we drive toward our bold ambition to become the global leader in healthcare technology.”

With more than 30 years of experience in healthcare innovation, Fonseca currently holds responsibility for dev…

They said it at DeviceTalks Boston

Proximie CEO Nadine Hachach-Haram [Photo courtesy of Proximie]Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead.

Here are some of the most quotable insights from panelists and speakers at our live event.

And make sure to save the date — and save your seat — for DeviceTalks West in Santa Clara, California on Oct. 19 and 20.

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