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10-year data shows durable outcomes with Medtronic Endurant stent graft system

The Endurant stent graft system. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced positive results from its 10-year post-market registry for the Endurant stent graft.

The Endurant stent graft system offers Endovascular aneurysm repair (EVAR) to treat patients with abdominal aortic aneurysm (AAA). Medtronic posted the real-world data at the 2023 Charing Cross Symposium in London, marking the completion of the study.

Dr. Hence Verhagen, ENGAGE investigator, called the data “strong and robust evidence” demonstrating long-term durable outcomes. Verhagen serves as chief of vascular surgery at Erasmus University Medical Center in Rotterdam, The Netherlands. He also presented the data in London.

The ENGAGE registry evaluated more than 1,200 patients. Ten-year data included follow-up from approximately 400 of these patients and showed a 94.7% freedom from aneurysm-related mortality. It also demonstrated a 64.1% sac regression (or decrea…

The pizza box problem — and why it might kill everything from Teflon to drugs

By Mark Jones

It looks innocuous in my hand, yet there are growing calls to ban it. It may use technology created for the Manhattan Project, but, in my hand, it doesn’t feel like a weapon. It feels natural, in spite of the very unnatural materials it may contain. I’m not at all cautious as I open it. Reaching in, I grab a slice. I do love pizza.

Pizza predates the Manhattan Project. Although pizza technically isn’t the problem, it’s the box. Cardboard for pizza boxes have been made resistant to both grease and steam using fluorocarbons. Five years ago, almost certainly, per- or polyfluorinated alkyl substances, PFAS, would have been used. Some states have now banned PFAS in things like pizza boxes. I’m not in one of those states. I can’t be sure whether the box in my hand uses PFAS or not.

PFASes were initially identified as a health concern at hotspots. There are many maps with marke…

The pizza box problem — and why it might kill everything from Teflon to drugs

By Mark Jones

It looks innocuous in my hand, yet there are growing calls to ban it. It may use technology created for the Manhattan Project, but, in my hand, it doesn’t feel like a weapon. It feels natural, in spite of the very unnatural materials it may contain. I’m not at all cautious as I open it. Reaching in, I grab a slice. I do love pizza.

Pizza predates the Manhattan Project. Although pizza technically isn’t the problem, it’s the box. Cardboard for pizza boxes have been made resistant to both grease and steam using fluorocarbons. Five years ago, almost certainly, per- or polyfluorinated alkyl substances, PFAS, would have been used. Some states have now banned PFAS in things like pizza boxes. I’m not in one of those states. I can’t be sure whether the box in my hand uses PFAS or not.

PFASes were initially identified as a health concern at hotspots. There are many maps with markers locating these hotspots contaminated most commonly by some intense u…

Spotlight on the top 10 pharma employers of 2023

[Image courtesy of kwanchaift/Adobe Stock]

This roundup explores the top 10 pharma employers of 2023, highlighting their strengths and areas for improvement based on employee reviews and industry trends. In our ranking of top employers, we combined data from multiple sources using a weighted approach, emphasizing employee satisfaction, company benefits and industry recognition. Topping the list are Recursion Pharmaceuticals and Ultragenyx. Both won employee support for their strong culture, supportive leadership and commitment to employee well-being.

Criteria for ranking the top 10 pharma employers of 2023

Before diving into the top 10 pharma employers of 2023, it’s important to note the factors contributing to their success. We considered multiple metrics in this listing. To rank the companies, we used a weighted approach, assigning 0.7 weight to Glassdoor ratings and 0.3 weight to Comparably ratings. On…

FDA clears vascular biometric monitor from CardieX

The Conneqt Pulse system. [Image courtesy of CardieX]CardieX announced today that it received FDA 510(k) clearance for its Conneqt Pulse vital signs monitor system.

Irvine, California-based CardieX designed Pulse for vital signs monitoring for use at home, by clinicians and in clinical trials. It provides measurements of both brachial blood pressure and central blood pressure, plus other vascular health biomarkers.

Pulse uses CardieX’s patented SphygmoCor technology for central blood pressure and non-invasive arterial waveform analysis. The system provides heart health insights previously only available in hospitals, research institutions and clinical trials, CardieX says. It uses the same pulse wave analysis technology used by cardiologists to predict arterial pressure in the aorta.

FDA clearance means CardieX can expand its SphygmoCor technology to use in decentralized clinical trials, remote patient monitoring and at-home self-monitoring. Its vascu…

GE HealthCare launches next-gen intraoperative ultrasound tech

The bkActiv system. [Image from GE HealthCare/BK Medical]GE HealthCare (Nasdaq: GEHC) announced today that it made its bkActiv system available for guiding urology, colorectal and pelvic floor procedures.

BK Medical, a subsidiary of GE HealthCare, developed the flagship intraoperative ultrasound imaging system. It designed bkActiv to deliver high-performance ultrasound guidance with a simplified, intuitive user experience for surgeons.

GE HealthCare acquired BK Medical for $1.45 billion in December 2021.

The system features an automatic, no-touch autogain and advanced algorithms to provide high-level image quality. This enables confident decision-making during surgical procedures, according to a news release. GE HealthCare says the system allows for minimal user interaction so surgeons can focus on their patients.

According to the company, bkActiv allows for detailed, real-time surgical visualization. The latest addition enables enhanced image qualit…

Boston Scientific profits nearly triple in Q1

Boston Scientific (Nasdaq:BSX) + today announced Q1 results that beat the overall consensus forecast on Wall Street.

The Marlborough, Massachusetts-based company reported profits of $314 million, or 21¢ per share, on sales of $3.4 billion for the three months ended March 31, 2023, for a bottom-line gain of 185.5% on sales growth of 12% compared with Q1 2022.

Adjusted to exclude one-time items, earnings per share were 47¢, 4¢ ahead of The Street, where analysts were looking for $3.16 billion in sales.

“I’m pleased with our excellent results this quarter, which highlight our team’s strong performance across each business and region,” CEO Mike Mahoney said in a news release. “With a robust pipeline in 2023 and beyond, I’m optimistic about our ability to continue to deliver differentiated financial performance and the opportunity to reach more patients with life-changing therapies.”

In…

Integra LifeSciences stock takes a hit despite Street-beating Q1

Integra LifeSciences (Nasdaq:IART) + shares dipped today despite first-quarter results that beat the consensus revenue forecast.

Shares of IART slid 8.5% to $53.84 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 1.4%.

BTIG analyst Ryan Zimmerman said an implied set-up for the remainder of the year may be viewed as “challenging” by investors. Any reservations over Integra’s ability to hit its goals this year could be responsible for the stock dip.

The Princeton, New Jersey-based surgical and medical instrument maker posted profits of $24.2 million. That amounts to 29¢ per share on sales of $380.8 million for the three months ended March 31, 2023.

Integra posted a 26.4% bottom-line slide on sales growth of 1.1%. Codman specialty surgical segment sales grew by 0.3% while tissue techn…

MiniMed 780G a ‘monumental improvement,’ Medtronic Diabetes head says

The MiniMed 780G with Guardian 4 and a 7-day infusion set. [Image courtesy of Medtronic]It’s been a long road for the Medtronic (NYSE:MDT) Diabetes unit to get its next-generation technology to market.

For years, clinical data backed up the MiniMed 780G insulin pump with Guardian 4 sensor technology. Over the last year alone,

The company hit an initial hiccup with an FDA warning letter related to its California Diabetes facility in 2021. CEO Geoff Martha said early in 2022 that the letter was likely to impact the regulatory timelines for next-generation technology. Meanwhile, analysts were suggesting that the unit was on the spinoff block.

For now, those issues are in the past, though. Medtronic yesterday said it fully resolved the warning letter with the FDA.

Just a few days earlier, Medtronic announced that it received FDA approval for MiniMed 780G with Guardian 4.

The system offers meal detection technology and provides automatic adjustment…

Fast Five: 3M lays off thousands of workers, another major insulin pump maker wins FDA nod

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, April 26, 2023.

Fast Five by MassDevice · 3M lays off thousands of workers, another major insulin pump maker wins FDA nod

Layoffs are becoming a common occurrence in the medical device industry, and they can be a result of various factors. Fast Five hosts Danielle Kirsh and Sean Whooley explore 3M’s latest layoff and what the company hopes to do in its restructuring efforts.

Insulin pumps are a crucial medical device for people living with diabetes. Insulet, one of the major diabetes device companies in the industry, recently won FDA clearance for its Omnipod GO. Whooley discusses what that means for diabetes patients and when they can expect to see the device on the market.

Proprio recently won FDA clearance for its orthopedic surgical navigatio…

Discover the 25 top pharma employers of 2023

[tilialucida/Adobe Stock]

The pharma and biotech sectors continue to face rapid change. On one hand, top pharma employers have continued to face talent shortages as demand increases for experienced workers. But on the other, the pharma sector has not been immune to layoffs. One factor driving the trend is the increased clip of mergers and acquisitions (M&A) activity, which can result in restructuring but also new job opportunities as companies sharpen their focus on pipeline gaps and developing novel therapeutics. The pharma industry is in the process of reassessing long-term strategies in domains such as sourcing, manufacturing and supply chain management, according to McKinsey. These trends have gained steam in recent years as a result of factors such as inflation, the ongoing pandemic, the shifting geopolitical climate and the development of novel therapeutic methods and new ways of working. The rapid evolution …

Lithium Ion Cycling Charge and Discharge

In this new report, we explore the cycling and performance characteristics of various-sized batteries under different conditions and highlight the performance of Resonetics lithium ion cells manufactured for implantable medical applications.

Read now via the form below.

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