Medtronic Archives - Page 20 of 59 - Medical Design Sourcing

FDA clears Medtronic’s Linq II for kids 2 and up

Medtronic Linq II insertable cardiac monitor [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for pediatric use of its Linq II insertable cardiac monitor (ICM) system.

The Linq II ICM initially received FDA clearance in 2020 for patients aged 21 or older. The clearance announced today allows for use in pediatric patients over 2 years old who have heart rhythm abnormalities and require long-term, continuous monitoring.

Medtronic said in a news release that Linq II is the first and only ICM to receive such clearance.

“For pediatric cardiologists who see many young patients needing continuous, long-term monitoring for infrequent or unknown heart rhythm conditions, this expanded indication for the LINQ II ICM is critically important,” said Dr. Jennifer Silva, director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital. “The …

4 major cardiology trends you need to know from TCT 2022

Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive.

The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations.

Medtronic, Abbott, Edwards and Boston Scientific represent a few of the companies revealing new data for their cardiovascular offerings. ReCor Medical, Abiomed and more got involved, too.

Plenty of the study outcomes represented positive steps forward, while other companies hit speed bumps in their efforts. Here are some of the biggest takeaways from the conference:

1. Renal denervation innovations plug along

Medtronic (NYSE:MDT) announced study data that demonstrates significant blood pressure reduction with the Symplicity renal denervation system.

The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the …

Medtech relief efforts begin after Hurricane Fiona hits Puerto Rico

Hurricane Fiona is still dropping rain on Puerto Rico as it moves toward the Dominican Republic, as seen in this Sept. 19, 2022 satellite imagery. [Image courtesy of the National Oceanic and Atmospheric Administration]

Power crews are restoring electricity in Puerto Rico after Hurricane Fiona struck with heavy rains and winds five years after Hurricane Maria made landfall.

Many large medtech companies have manufacturing operations in the U.S. island territory.

Medtronic (NYSE: MDT) has not received any reports of significant damage to its five facilities in Puerto Rico and planned to restart operations today if employees are safe and can report to work, the company told Medical Design & Outsourcing. The company also has a manufacturing facility in the Dominican Republic.

“Given the path of Hurricane Fiona, our teams have been monitoring and are continuing to monitor both Puerto Rico and …

Medtronic presents positive data on TAVR, TMVR devices

Medtronic Evolut TAVR. [Image from Medtronic]Medtronic (NYSE:MDT) announced data from multiple trials supporting its transcatheter heart valve replacement devices.

Data were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston. Results covered the company’s self-expanding transcatheter aortic valve replacement (TAVR) devices and its transapical transcatheter mitral valve replacement (TMVR) system.

Medtronic kicked off TCT by announcing the full U.S. launch of its next-generation Evolut FX TAVR system.

Examining HALT in Medtronic CoreValve and Evolut program

The Pathological Study of Hypo-Attenuated Leaflet Thickening (HALT) represents part of the CoreValve and Evolut program. It compares microCT and histology findings of valve leaflet thickening. Medtronic said in a news release that the trial is the first to compare such things. It may provide clinical insights into the long-term durability of transcatheter aorti…

Medtronic fully launches its next-gen TAVR in U.S.

The Evolut FX TAVR [Image courtesy of Medtronic]Medtronic (NYSE: MDT) marked the start of the TCT 2022 conference today by announcing the full U.S. launch of its Evolut FX TAVR system.

The medtech giant’s next-generation TAVR won FDA approval in 2021, followed by a limited roll out earlier this year. Edwards Lifesciences —Medtronic’s major U.S. competitor in the transcatheter aortic valve replacement space — announced the launch of its next-gen Sapien 3 Ultra Resilia heart valve earlier in the week.

The Evolut FX system incorporates design changes. For example, it includes gold markers built into the frame to provide implanters with direct visualization of commissure alignment.

There’s also a redesigned catheter tip for a smoother insertion profile. Delivery system flexibility features include an optimized stability layer for a more stable, predictable deployment. As with its Evolut Pro+ predecessor, there are four valve sizes — a large in…

Medtronic prices $3.5B of senior notes

Medtronic (NYSE:MDT) announced that it priced an offering of senior notes totaling approximately $3.4986 billion (€3.5 billion).

The offering includes $500 million principal amount of 2.625% senior notes due 2025. It then features $1 billion in 3% senior notes due 2028, $ billion in 3.125% senior notes due 2031 and $1 billion in 3.375% senior notes due 2034.

All of Medtronic’s obligations under the notes will be fully and unconditionally granted by the company, according to a news release.

The medtech giant expects to use proceeds to repay at maturity its outstanding 0% senior notes due 2023, 0.375% notes due 2023 and 0% notes due 2023. Other uses include general corporate purposes. The company may elect to repay, redeem or repurchase the notes prior to maturity but currently has no intention of doing so.

Medtronic expects the offering to close on Sept. 21, 2022. The joint book-running managers for the Offering are Barclays Bank PLC, BofA Se…

Ex-Medtronic VC leader David Neustaedter starts his new job

David Neustaedter was formerly Medtronic’s VP of venture investments. [Photo courtesy of Medtronic]

David Neustaedter, the former VP of venture capital at Medtronic (NYSE: MDT), said today that he is now a venture partner at Deerfield Management Co.

Neustaedter said on LinkedIn that he started in his new role in the New York-based investment firm’s medical technologies practice this week.

August was his last month with Medtronic after a 14-year career, including seven years at Covidien before Medtronic bought it. It’s not clear who will replace him at Medtronic; the company has not responded to messages seeking more information.

PREVIOUSLY: Medtronic’s VC leader discusses risk, returns, strategy and an ‘ugly truth’

Deerfield reported more than $16.2 billion worth of assets under management for 10 clients identified as pooled investment vehicles in its latest disclosure wit…

The 10 largest medtech employers — and what their employees really think

Employees of the 10 largest medtech employers are happy to be a part of a company that is having a positive impact on patient populations.

That was one major takeaway as MassDevice compiled some current and former employee reviews posted on Glassdoor.

Medtronic, Philips and Johnson & Johnson MedTech top the list of largest medtech employers. The 10 companies we looked at were the largest employers in Medical Design & Outsourcing‘s newest Big 100 report on the largest medical device companies.

Company Employees Medtronic 95,000 Philips 78,189 Johnson & Johnson MedTech 75,000

As with most companies, there are some qualms with corporate bureaucracy and reorganizations creating frustration for employees.

Employment in the medtech industry is on the rise, according to a recent analysis of our Medtech Big 100 data. There were 1,268,924 employees among the 100 largest companies that report human capital in their annual repor…

Investors sue Medtronic over insulin pump problems

An FDA warning letter for Medtronic’s Diabetes business cast uncertainty over approval of the company’s next-gen MiniMed 780G system. [Image from Medtronic]Add a potential class action shareholder lawsuit to the challenges Medtronic (NYSE: MDT) is facing over its Diabetes business.

The law firm of Kessler Topaz Meltzer & Check announced last week that it has sued the medtech giant in U.S. District in Minnesota, claiming securities fraud over how it disclosed insulin pump problems.

The initial plaintiffs in the suit are the Trustees of the Welfare and Pension Funds of Local 464A – Pension Fund, the trustees of the Local 464A United Food & Commercial Workers’ Union Welfare Service Benefit Fund, and the trustees of the New York-New Jersey Amalgamated Pension Plan for Acme Employees.

The complaint, filed September 8, is also against present and former top Medtronic executives. It claims that they repeatedly assured investors from 2019 onward that FDA a…

Titan Medical, Medtronic strike development deal on surgical robots

Titan Medical (TSX:TMD;OTC:TITFX) today announced the signing of a definitive agreement with medtech giant Medtronic (NYSE:MDT).

Under the definitive agreement, the two companies will build upon a development and license deal agreed in June 2020. Titan achieved all three milestones laid out in the agreement, including raising $18 million in capital in October 2020.

It also received a $10 million payment for the second milestone and an additional $11 million for the completion of the third technical milestone. Titan received the final milestone payment from Medtronic in January. In May, Titan signed a $2.6 million purchase order from Medtronic.

The latest deal between the two companies comprises a limited development program. It also includes a preclinical collaboration to evaluate instruments and cameras in gynecological procedures. The agreement also includes the potential for future activities associated with the commercial supply of instruments and ca…

Medtronic VC leader David Neustaedter leaves the company

David Neustaedter was formerly Medtronic’s VP of venture investments. [Photo courtesy of Medtronic]

David Neustaedter, VP of venture capital at Medtronic (NYSE: MDT), has left the world’s largest medical device maker for a private investment firm.

Neustaedter said on LinkedIn that August was his last month with Medtronic after a 14-year career, including seven years at Covidien before Medtronic bought it.

He did not name his next company, but said he is “looking forward to learning from a new group of talented professionals, and continuing to [support] some of the most promising companies in medtech.”

PREVIOUSLY: Medtronic’s VC leader discusses risk, returns, strategy and an ‘ugly truth’

The finance executive said he has served as director or observer on the boards of more than 25 venture-backed companies during his time at Medtronic. He estimated 1 million to 2 mill…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers top the Big 100 list of largest medical device companies by revenue.

The 2022 edition of MassDevice and Medical Design & Outsourcing‘s Big 100 report also holds surprises. Big conglomerates are spinning out medtech businesses as stand-alone companies, and that means changes to the list of 100 largest medical device companies.

Colfax, for example, engaged in business moves that turned DJO’s parent into Enovis, a large, stand-alone orthopedic device company that is No. 56 in 2022’s Big 100. ZimVie, formerly Zimmer Biomet’s spine and dental business, is 69th. And after decades under larger corporate umbrellas, Cordis debuts at No. 76 on the list.

We collected thousands of data points to size up the industry’s publicly traded companies and privately held firms. The Big 100 includes annual revenue, R&D spending, employee counts, key leaders, headquarters locatio…