Medtronic Archives - Page 22 of 59 - Medical Design Sourcing

Medtronic has Class I recall for low-shock risk in ICDs

Medtronic Cobalt and Crome ICDs [Image from Medtronic]Medtronic (NYSE: MDT) is recalling 22,110 Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in the U.S.

The Class I recall — the most serious classification from the FDA — is due to the potential for reduced shock energy during high-voltage therapy for Cobalt and Crome ICDs and CRT-Ds, according to FDA data.

Some devices have been found to deliver only around 79% of the programmed energy, which Medtronic estimates has a 1% reduction on efficacy.

Medtronic said there have been no reports of permanent harm or deaths due to the issue.

In June, Medtronic issued an urgent field safety notice in Europe warning of the same problem.

Medtronic is not recommending replacement of implanted devices. A software update is expected to fix the problem in new and existing implantations. Medtronic is asking hospitals to return certai…

FDA reports sterilization challenge progress as EPA takes aim at EtO emissions

Ethylene oxide (EtO) gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. [Photo courtesy of the FDA]

The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities.

The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.

Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.

“In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news…

EPA flags high-cancer-risk EtO sterilization facilities across the country

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices — and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cance…

Medtronic’s Design for Reliability and Manufacturability after the reorganization

Mike Hess is VP of corporate technology and innovation at Medtronic. [Photo courtesy of Medtronic]

“Play small and play big” was one of CEO Geoff Martha’s mantras as he and his team reorganized Medtronic (NYSE:MDT), the biggest corporation in medtech.

The multi-year effort decentralized Medtronic’s three big groups — cardiology, neuroscience and medical surgical — into 20 narrowly focused operating units (OUs).

“The OUs can maintain focus and accountability, execute faster and make quicker decisions, while retaining the advantages of size and scale. … Play small and play big,” Martha said in an October 2020 communique.

Fast forward to today. Mike Hess, VP of corporate technology and innovation, calls Medtronic’s Design for Reliability and Manufacturability (DRM) program a “great example of the play big, play small mindset.”

“The DRM team…

How Medtronic aims to address health inequities in diabetes

Fueled by personal experience, Maribel Baker leads Medtronic’s diabetes business toward improving health equity.

At 15 years old, Maribel Baker’s life was in the balance.

While growing up in Panama, Baker had to undergo leg surgery because she was born with one leg shorter than the other. Following the surgery, she learned that she had a staph infection. Doctors wanted to amputate the infected leg, but Baker’s parents fought for an opportunity in front of the Medical Board of Panama to bring their daughter to the U.S. for surgery, earning a grant to have the operation in Miami.

After her first surgery in Miami, Baker told Drug Delivery Business News that she was “so weak” as her mother attempted to tell the nurse something was wrong. English was the second language of Baker and her family and there was some miscommunication, but the nurse at the time denied anything was amiss. Overnight, Baker’s mother did not sleep, waiting for a new nurse shift to beg…

The 10 largest orthopedic device companies in the world

Stryker, Johnson & Johnson’s DePuy Synthes and Zimmer Biomet top the list of largest orthopedic device companies. [Adobe Stock image]With elective procedure numbers rebounded after the darkest days of the COVID-19 pandemic, most of the world’s largest orthopedic device companies saw their revenues increase by double-digit percentages during their most recent fiscal years.

Here are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports:

Largest orthopedic device companies Annual revenue (% change) Headquarters 1 Stryker $17.1 billion (+19.2%) Kalamazoo, Michigan 2 Johnson & Johnson – DePuy Synthes $8.6 billion (+10.6%) Locations: Raynham, Massachusetts.; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida 3 Zimmer Biomet (minus ZimVie spinoff) $6.8 billion (+11.6%) Warsaw, Indiana 4 Medtronic – Cranial & Spinal Technologies $4.5 billion (+3.9%) Locat…

6 drug delivery innovations you need to know

From wearable insulin delivery devices to drug-eluting implants and everything in between, drug delivery innovation never stops.

Vaccines, life-saving therapeutics, vision-correcting drugs and more are being developed and marketed for delivery with all kinds of technologies.

More than a year ago, we compiled a list of eight drug delivery innovations you need to know. With some updates on some of those technologies, plus introductions to others, here are some more impressive developments you should keep an eye on:

1. Needle-free delivery

Vaccines have become a major talking point over the past couple of years amid the COVID-19 pandemic and a number of companies are working on ways to deliver them, as well as other forms of medication, through different avenues.

A major speed bump in vaccine hesitancy can be fear of needles, so the introduction of needle-free drug delivery could make big waves in the space.

Two companies pushing forward with …

The biggest medtech personnel moves so far in 2022

In the ever-changing world of medtech, those who are leading the companies are bound to move around a bit.

At the end of last year, we compiled a list of medtech’s biggest personnel changes in 2021. Throughout just over half of 2022, we’ve already seen a slew of major moves around some of the space’s most powerful players.

Here is a list of some of the biggest personnel changes in medtech so far in 2022:

3M’s healthcare president retires 3M Health Care Business Group President Mojdeh Poul [Image courtesy of 3M]Mojdeh Poul, the president of 3M’s healthcare business, announced in May that she would retire from the position and her retirement was made effective on July 1.

Poul joined 3M in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions, including infection prevention, 3M Canada, and sa…

Design challenges to overcome when developing cardiac ablation devices

Acutus Medical’s AcQBlate Force sensing ablation catheter. Image courtesy of Acutus Medical

It’s about figuring out how and where to go with the cardiac ablation and then engineering the best catheter-based delivery device, according to a top Acutus Medical scientist.

Cardiac ablation is when a physician intentionally destroys a small amount of tissue in the heart to treat and prevent heart rhythm problems. The procedure creates therapeutic scars in the heart to block the irregular electrical signals that cause an uneven heartbeat.

To perform cardiac ablation, a physician inserts a thin, flexible catheter through veins or arteries into the heart. Sensors on the tip of the catheter detect the electrical signals inside the heart, which allows a cardiologist to pinpoint which area of the heart requires ablation.

Ablation devices mostly use heat (radiofrequency energy), extreme cold (cryoablation)…

Medtronic, ASGE to expand colon screening program for underserved communities

Medtronic’s GI Genius intelligent endoscopy module [Image courtesy of Medtronic]Medtronic (NYSE:MDT) and the American Society for Gastrointestinal Endoscopy (ASGE) today announced a program expansion.

With support from Amazon Web Service’s (AWS) Health Equity Initiative, Medtronic and ASGE are expanding the Medtronic Health Equity Assistance Program for colon cancer screening in medically underserved communities across the U.S., increasing GI Genius units (provided as part of the program) from 50 to 133 systems placed at 62 facilities.

The program launched in February 2022, according to a news release, with Grady Memorial Hospital in Atlanta the first to receive its donated GI Genius units last month. Gastroenterologists at Grady Memorial Hospital perform more than 7,000 colon cancer screening procedures each year among a predominantly Black community, Medtronic said, as Black adults are disproportionately burdened by colon cancer, at greater risk of diagnos…

Report: Medtronic to add 200 jobs in Galway

Medtronic (NYSE:MDT) will reportedly be adding 200 research and development positions in Galway, Ireland.

According to a report in The Independent, the medtech giant has already filled more than half of the R&D roles, which come as part of a $30 million investment.

“These roles will support the development of products and services in the coronary artery, heart valve and peripheral vascular disease, heart arrhythmia and pacing, hypertension and spinal injury areas,” Gerard Kilcommins, Medtronic VP of global manufacturing, vascular therapies and implants and country director told The Independent.

Other jobs in the areas of chemical analysis and biocompatibility for supporting Medtronic’s global laboratory services team will also be available, the report said. The 200 new jobs add to approximately 4,000 employees already operating across Ireland, where the company’s corporate headquarters are located (Dublin).

The company is marking 4…

FDA clears Medtronic’s next-gen UNiD spine analyzer

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its UNiD spine analyzer v4.0 planning platform.

The UNiD spine analyzer v4.0 includes a new Degen algorithm for degenerative spine procedures, with the algorithm designed to leverage machine learning to help surgeons plan and personalize procedures for patients undergoing lower lumbar spine surgery and predicts spinal compensation mechanisms six months after the operation.

According to a news release, the new update includes enhancements to the pediatric and adult deformity algorithms predicting compensatory changes to the spine. The company said it is the first and only company with FDA-cleared predictive models for spine surgery.

Medtronic’s release comes with a new UNiD hub patient-centric platform that enables surgeons to track patients throughout the perioperative care pathway and assess surgical results through long-term radiographic and patient-reported outcomes d…