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…

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These 10 medtech companies’ stocks performed best in 2021

(From Ishant Mishra on Unsplash)

Following a year like no other in 2020, 2021 was when many looked to rebound — including the medtech industry.

A number of medtech companies followed up a challenging, pandemic-enveloped year with impressive performances. Plenty of them had already proven in 2020 that they were capable of a quick bounce-back.

Here are 10 medtech companies that saw their stocks soar even higher in 2021:

(This list includes members of the MassDevice MedTech 100 Index of the world’s largest medical device companies. Performance is measured in stock price change from Dec. 31, 2020, to Dec. 31, 2021.)

Get the full story at our sister site, MassDevice.

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Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12 percent despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

TAVR sales outside the U.S. grew about 20 percent on an underlying basis in Q4, and Edwards Lifesciences said it continues to project that the global TAVR opportunity will double to $10 billion by 20…

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Edwards Lifesciences stock slides on Q3 financial results

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15% from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20% on a year-over-year basis.

Get the full story at our sister site, MassDevice.

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September 2021 Issue: Our latest Medical Device Handbook is out!


Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte  — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …
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3 pitfalls to consider when creating catheter delivery systems

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]

Multiple components go into a catheter delivery system, with several ways to combine them. An Edwards Lifesciences senior R&D director goes over potential pitfalls.

A catheter is a tube that can deliver devices or pharmaceuticals into the body. It is also commonly used for diagnostic purposes. A catheter has a hub or a handle on its end that can connect to a syringe or something that actuates a device.

There are a number of catheter delivery systems currently on the market that deploy devices such as heart pumps, balloons, stents and other clot-busting products.

The catheters need to be small enough to fit through the blood vessels and flexible enough to navigate the human body’s complex cardiovascular system.

Sean Chow, a senior director of R&D at Edwards Lifesciences, told Medical Design &…

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Edwards Lifesciences to spend $100M to promote racial equity

Edwards Lifesciences today announced that it established a Social Impact Investment Fund to advance racial equity in healthcare.

The $100 million fund is a portfolio of investments that are aimed at advancing racial equity through economic development in Black and underserved communities in the U.S.

“Events in 2020 prompted reflection on how we could expand Edwards’ active community engagement to provide even more support for our employees and communities, particularly as it relates to social equity and justice,” chief financial officer Scott Ullem said in a news release. “We believe that increasing the availability of capital in underserved areas can contribute to a virtuous cycle of job creation, wealth-building and other new opportunities for economic development, while also providing a return to investors. This initiative is aligned with our values and with the elements of our Credo focused on creating a community unified in its mission to improve quality o…

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The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…

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Edwards Lifesciences tricuspid valve reduced leakage in 98% of patients

Edwards Lifesciences‘s Evoque tricuspid valve replacement system reduces tricuspid heart valve leakage to non-traceable or mild leakage in 98% of patients, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

Evoque is designed to replace native tricuspid valves without open-heart surgery. The valve is implanted using a minimally invasive delivery system where a doctor places a thin tube through a vein in the leg to reach the patient’s heart and perform the valve replacement procedure.

The single-arm feasibility Triscend study found that the device deployed as intended and had no clinically significant paravalvular leak and good safety outcomes. Patients also showed significant improvements in six-minute walk distance and New York Heart Association physical function categories.

There were 56 patients in the study who had an average Kansas City Cardiomyopathy Questionnaire overall summ…

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4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]

Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients a…

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8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]

Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery fo…

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How big medtech fared during a year of COVID-19

[Photo from Unsplash]

Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, …

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