Vaporized hydrogen peroxide for medical device sterilization

A molecular model of hydrogen peroxide (H2O2) [Illustration by petrroudny via Adobe Stock]

Vaporized hydrogen peroxide (VHP) is the latest medical device sterilization alternative to ethylene oxide (EtO) as the industry seeks to limit potential harm from EtO and increase total sterilization capacity.

Vaporized hydrogen peroxide (also referred to as VH₂O₂) is the FDA’s newest addition to its list of Established Category A sterilization methods for medical devices. Other Category A sterilization methods include EtO, dry heat, moist heat and radiation.

Like the aqueous form of hydrogen peroxide (H₂O₂), VHP (also referred to as VH₂O₂) kills infection-causing bacteria, viruses and all other microbial life by oxidizing amino acids and proteins.

VHP has a similar effectiveness as EtO, which is the most commonly used method for medical device sterilization. Like EtO, VHP can permeate many materials …

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How does medtech CEO compensation compare?

[Image from Unsplash]Medtech CEO compensation averaged $10.5 million during the companies’ most recent fiscal years.

That number from our recent MassDevice analysis may seem like a lot to an average person — but not as much in the world of corporate CEOs.

In fact, the average compensation of S&P 500 company CEOs was $25.2 million in 2022, according to the Economic Policy Institute (EPI), a nonprofit research institute that studies the impact of economic trends and policies on working people in the U.S.

Geoff Martha, who, as CEO of Medtronic, runs the world’s largest medical device company, saw a total compensation of $15.4 million. But look over at the pharmaceutical industry, where revenue numbers are much higher, and the head of the world’s largest pharma company — Pfizer CEO Albert Bourla — brought in $33 million.

As businesses mature into publicly traded companies and revenue grows, it makes sense for CEO compensation to become larger.

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Stryker expands Gamma4 hip fracture nailing system

The Gamma4 hip fracture nailing system. [Image courtesy of Stryker]Stryker (NYSE: SYK) + announced today that it expanded its Gamma4 hip fracture nailing system by adding an intermediate nail.

The latest expansion received FDA 510(k) clearance in June 2023.

Since its 2022 launch, Gamma4 has been used in more than 19,000 cases across more than 850 facilities. Kalamazoo, Michigan-based Stryker now incorporates the RC Lag screw and an anti-rotation clip with sleeve components in the Gamma4.

Gamma4 is indicated for the treatment of stable and unstable fractures. It also offers an option for the stabilization of bones and correction of bone deformities. This extends to cases with the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur.

New features of Gamma4 include increased cutout resistance. Stryker says the new screw increases this by 15% compared to the standard Gamma4 lag screw. Addi…

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First arthroplasty procedures performed with Stryker mixed-reality guidance system

The Blueprint MR guidance. [Image courtesy of Stryker]Stryker (NYSE: SYK) + announced today that surgeons completed the first shoulder arthroplasty surgeries using its mixed reality (MR) guidance.

Dr. Joaquin Sanchez-Sotelo of Mayo Clinic and Dr. George Athwall of St. Joseph’s Health Care (London, Canada) performed the surgeries.

Kalamazoo, Michigan-based Stryker designed its Blueprint MR guidance system to combine software with the Microsoft HoloLens 2 headset. It allows the surgeon to track the position and orientation of surgical instrumentation in the physical environment.

Blueprint MR guidance uses 3D images and widgets to guide surgeons and their instruments. Displayed on the patient and in the surgeon’s line of sight, the images and widgets avoid disrupting the surgical workflow. The FDA cleared this system about a year ago.

Dr. Sanchez-Sotelo said individualized care platform can cater to…

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FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

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The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

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Stryker to acquire joint replacement company SERF SAS

Stryker (NYSE: SYK) + announced today that it executed a binding offer to acquire SERF SAS, a France-based joint replacement company.

The Kalamazoo, Michigan-based orthopedic giant executed the offer with Menix, a leader in the dual mobility and first intention stem markets in France.

SERF SAS develops, manufactures and sells a range of large joint replacement products on an international basis. Since its founding, which dates back more than 50 years, the company developed a number of “innovative concepts,” Stryker says. This includes inventing the original Dual Mobility Cup for hip replacement, according to a news release. SERF SAS has its main office in Décines-Charpieu, France.

Stryker said SERF SAS has global recognition from healthcare professionals as an innovator in the hip implant space. The company believes the acquisition complements its existing presence in France and in Europe as well. It…

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Medtronic weighs in on GLP-1 impact for device manufacturers

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

Medtronic is the latest — and largest — device manufacturer to weigh in on GLP-1 weight loss drugs and how they could affect demand for medical devices.

Medtronic Chair and CEO Geoff Martha today said the world’s largest medical device company doesn’t expect GLP-1 (glucagon-like peptide-1) drugs like Ozempic and Wegovy to take a big bite out of its business.

While Medtronic said the drugs have had a “modest impact” on the bariatric surgery market, Medtronic thinks that is only temporary. The rate of decline in Medtronic’s bariatric business has already stabilized, Martha said on the company’s second-quarter earnings call, adding, “I think we see that coming back in the coming year.”

“We feel strongly that we don’t see these drugs impacting Medtronic’s growth, medium …

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Stryker beats The Street in Q3, CEO Lobo allays GLP-1 fears

Stryker (NYSE: SYK) + shares fell slightly this morning on third-quarter results that topped the consensus forecast.

Shares of SYK dipped 1.8% at $273.22 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 1.4%.

The Kalamazoo, Michigan-based company posted profits of $692 million, equaling $1.80 per share. It recorded sales of $4.91 billion for the three months ended Sept. 30, 2023.

Stryker reported a 15.2% bottom-line slide despite sales growth of 9.6%.

Adjusted to exclude one-time items, earnings per share totaled $2.46. That landed 3¢ ahead of expectations on Wall Street, where analysts projected sales of $4.86 billion.

The orthopedic giant reported MedSurg and Neurotechnology sales of $2.9 billion, rising 10.5% year-over-year. Stryker attributed some of that growth to increased unit volu…

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Why Stryker says GLP-1 weight loss drugs could boost joint replacements

Stryker says weight loss drugs could help obese patients slim down for knee and hip replacements. (Pictured is Stryker’s Triathlon Cementless knee.) [Image courtesy of Stryker]

Executives at Stryker, the world’s largest orthopedic device manufacturer, say they’re not afraid that GLP-1 weight loss drugs could hurt demand for joint replacement implants.

Instead, they see GLP-1 drugs — including Ozempic and Wegovy — as a neutral factor or perhaps even a slight positive. That’s because the drugs could help obese and near-obese patients slim down to qualify for knee and hip replacement surgery.

“We don’t anticipate the weight loss drug having a negative impact,” Lisa Kloes, the GM and VP of Stryker’s knee business, said in an interview with Medical Design & Outsourcing. “Actually, we think it’s going to help with implant volumes. There’s qu…

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Stryker CEO Kevin Lobo offers supply chain update after ‘wild year’

Kevin Lobo is CEO and chair of Stryker. [Photo courtesy of Stryker]

The medtech industry as a whole suffered over the past year or so as supply chain issues — namely semiconductors — came to a head.

Midway through last year, Medtronic CEO Geoff Martha labeled it as a problem for everyone as medtech’s biggest names navigated serious shortages of chips and other key supplies.

An industry survey from Deloitte showed that some medtech manufacturers slowed down or halted manufacturing operations after depleting their semiconductor inventories. Nearly 80% of survey respondents reported extended lead times, with some stretching more than a year.

At AdvaMed’s The MedTech Conference on Monday in Anaheim, Stryker Chair and CEO Kevin Lobo explained the low point that his company and the industry hit last year.

“In this industry, we never had to worry about [chip supply] before,” Lobo…

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State of the industry — Execs ‘more bullish than ever’ on medtech

From left: Kevin Lobo, Lisa Earnhardt, Deepak Nath, Bernard Zovighian. All spoke about the state of the industry at The MedTech Conference.

Ernst & Young’s 2023 Pulse of the Industry medical technology report may not have been overly positive, but medtech executives certainly are.

The EY report highlighted sluggish revenues and post-COVID-19 corrections leading to a growth decline. In fact, it was the lowest growth in medtech since 2015. Roughly half of medtech stock price gains realized in 2021 were wiped out by the end of 2022.

However, leading medtech executives, including Stryker CEO Kevin Lobo, only see upwards.

“I feel as bullish as I’ve ever felt in my time in medtech,” Lobo declared.

Lobo, Abbott EVP of Medical Devices Lisa Earnhardt, Smith+Nephew CEO Deepak Nath and Edwards CEO Bernard Zovighian all have positive outlooks for the space. They outlined their views on a panel based around the EY report Monday at T…

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