Medtronic Archives - Medical Design Sourcing

New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

Sterilization startup Phiex adds ex-Medtronic chief medical and scientific officer as advisor

Phiex advisor Dr. Rick Kuntz was formerly Medtronic’s chief medical and scientific officer. [Photo courtesy o Kuntz]

Retired Medtronic Chief Medical and Scientific Officer Dr. Rick Kuntz has joined Phiex as an advisor as the medical device sterilization startup works toward commercialization.

Phiex is developing a new method for medical device sterilization using dry powder that generates chlorine dioxide gas inside product packaging.

The company sees a big opportunity to offer an alternative to ethylene oxide (EtO) sterilization, which is the most commonly used method in medtech but faces new safety regulations over health risk concerns.

“It’s clear that EtO’s going to have to go away. It’s just not going to be tolerated … and I just think this is the best alternative,” Kuntz said today in an interview with Medical Design & Outsourcing.

Kuntz j…

Medtronic names former Amazon consumer robotics VP as chief technology and innovation officer

Medtronic (NYSE: MDT) + today announced it appointed former Amazon executive Ken Washington as chief technology and innovation officer.

In this newly created role, Washington will leverage his extensive experience leading technology development and execution across industries, including robotics, consumer products, automotive and space. He will also become a member of the Medtronic Executive Committee.

“This new leadership role will help Medtronic to harness the innovative spirit of our founders and ensure we are capitalizing on our scientific and technological knowledge to invent, innovate and disrupt the healthcare technology market of the future,” Chair and CEO Geoff Martha said in a news release. “Dr. Washington will help Medtronic expand use of our technology platforms across our portfolio – including robotics, sensors, implantables and AI – improving our returns on investments in innovation and …

A veteran Medtronic executive takes a new role at Baxter

Julie Brewer, president of Patient Support Systems, Global Surgical Solutions and Care Communications at Baxter [Image from Brewer’s LinkedIn profile]Medtronic Cardiovascular Diagnostics and Services President Julie Brewer has left for a new position at Baxter.

Brewer announced on LinkedIn near the end of last week that she has joined Baxter (NYSE: BAX) + as President of the Patient Support Systems, Global Surgical Solutions and Care Communications team.

“Baxter is a great company with a wonderful purpose of saving and sustaining lives,” Brewer said. “I spent the last couple of days meeting many on the team and came away energized and excited about the road ahead.”

Brewer also had positive words about Medtronic (NYSE: MDT) + , where she started as an area VP and rose through the ranks.

“After almost 17 years with Medtronic, I am mov…

Medtronic faces a wait-and-see attitude from analysts

Medtronic (NYSE: MDT) + stock continues to decline today — a day after it underwhelmed The Street with its growth projection for its new fiscal year.

MDT shares were down more than 2% to $81.58 apiece by midday today — a day after the stock fell another 2% in value. Meanwhile, MassDevice’s MedTech 100 Index — as well as the S&P 500 — were up on hopes that President Joe Biden and House Speaker Kevin McCarthy are close to striking a debt ceiling deal.

For the fiscal year ending in April 2024, Medtronic expects 4–4.5% revenue growth. One analyst described the guidance as “worse (more conservative?) than we expected.” Company officials told analysts during yesterday’s earnings call that they wanted to be prudent. They said they’re seeking durable revenue growth.

Even as it divests some businesses and engages in significant cost reductions including layoffs, Medtronic is also boosting R&D sp…

The top cardiac care innovation news at Heart Rhythm 2023

The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.

Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.

Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.

The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.

Get the full story on o…

Analysts still high on Insulet despite Medtronic’s EOFlow buy, stock market reaction

The Insulet Omnipod 5 (left) and the EOFlow EOPatch (right), just acquired by Medtronic.

Despite a negative reaction from investors following a major buy in the insulin delivery space, analysts still back Insulet (Nasdaq:PODD) stock to perform.

Shares of PODD fell throughout today after Medtronic (NYSE:MDT) announced a $738 million acquisition of EOFlow. Korea-based EOFlow develops the EOPatch, a tubless, wearable and fully disposable insulin delivery device. Insulet represents a market leader in that space with its own Omnipod patch pump platform. Omnipod 5 became the first available tubeless, wearable, automated insulin delivery system after the FDA cleared it in January 2022.

By mid-afternoon, shares of PODD fell 7.3% to $272.24 apiece. Tandem Diabetes Care, another competitor in the space, saw its shares go down 5.5% to $26.62 apiece..

In spite of the negative reaction by the markets, BTIG analysts Marie Thibault and Sam Eiber expect Insulet to maint…

The top cardiac care innovation news at Heart Rhythm 2023

The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.

Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.

Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.

The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.

Here’s a roundup of Associate Editor Se…

Medtronic to acquire wearable insulin patch maker EOFlow for $738M

[Image from the EOFlow website]Medtronic (NYSE:MDT) announced today that it entered into a set of agreements to acquire insulin delivery technology developer EOFlow.

Seongnam, South Korea-based EOFlow develops the EOPatch, a tubless, wearable and fully disposable insulin delivery device.

EOFlow already launched its EOPatch insulin delivery system in Korea and Europe. The company submitted the insulin delivery device for U.S. FDA clearance in January. EOFlow already has FDA breakthrough device designation on a wearable, integrated artificial pancreas. The disposable device features a glucose monitoring sensor, insulin pump and automated insulin delivery algorithm.

Medtronic plans to add EOFlow’s offerings to its existing diabetes portfolio. That includes its Meal Detection Technology algorithm and next-generation continuous glucose monitor (CGM). The medtech giant just one month ago received FDA approval for its own insulin delivery technology, the Min…

Medtronic says its annual revenue could grow up to 4.5%

Medtronic (NYSE: MDT) + today reported fourth-quarter results that beat the consensus forecast on Wall Street amid accelerating revenue growth.

The world’s largest medical device company also announced an acquisition: roughly $738 million for South Korea–based EOFlow and its EOFlow insulin delivery patch that a user can control using their smartphone.

Medtronic forecast that it will grow revenue up to 4.5% in the new fiscal year — a turnaround from the 1.4% revenue decline it saw in its fiscal year 2022–23. However, its earnings forecast for the new fiscal year appeared to come up a bit short of The Street’s expectations.

The initial earnings release and presentation included no additional details about the layoffs taking place amid significant cost reductions as the company seeks to refocus and drive growth.

Investors appeared to be initially positive about the results. MDT shares were up sli…

Medtronic reports positive Harmony transcatheter pulmonary valve data

The Harmony transcatheter pulmonary valve. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced positive two-year results for a study of its Harmony transcatheter pulmonary valve (TPV) system.

Harmony treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The Medtronic analysis demonstrates strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT. The current standard of care is either open-heart surgery or other interventions early in life to address malformations. Harmony TVP provides a minimally invasive treatment alternative.

Medtronic presented results at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.

“Sharing these longer-term outcomes for the Harmony transcatheter valve is an important milestone to help offer more streamlined treatment options for patients living with congenital heart disease…

Study supports extravascular ICD from Medtronic

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced positive long-term follow-up results for its investigational implantable cardioverter defibrillator (ICD).

The medtech giant designed its extravascular (EV) ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Medtronic’s EV ICD pivotal study followed patients through an average of 17.1 months. The company presented data as late-breaking science at Heart Rhythm Society’s (HRS) 2023 meeting in New Orleans.

Medtronic’s first-of-its-kind implantable defibrillator aims to avoid certain risks of traditional, transvenous ICDs. It designed the system with a lead placed outside the heart and veins, under the sternum. Using a minimally invasive approach, the implant goes below the left armpit in the left mid-axillary region.

The ICD offers anti-tachycardia pacing (ATP) and pause prevention pacing. The device is similar …