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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…

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…

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…

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…

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 …

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…

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…

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…

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…

‘Love, yet fear’ — how medtech is stepping into the digital sphere

Robert Cohen of Stryker offered his thoughts on how medtech is adopting digital technologies. [Photo courtesy of Stryker]Dr. Rajiv Sethi likes to compare the implementation of digital technologies and automation in medtech to the automation in an airplane.

If the pilots experienced an issue with their technology or the weather, for instance, they could manually interject, he says. But, the “vast majority of the work” goes down to automation.

Sethi serves as a clinical professor for health systems and population health and executive director of the Center for Neurosciences and Spine at the University of Washington School of Medicine and Virginia Mason Medical Center. He explained his airplane and operating room analogy today at AdvaMed’s The MedTech Conference in Anaheim, California.

Sethi spoke on a panel titled “Digital is the New Frontier: Are We Stepping Into it Boldly?” (Want to find out more about digital surgery, artifici…

Stryker launches minimally invasive surgical bunion treatment

The PROstep MIS Lapidus. [Image courtesy of Stryker]Stryker (NYSE: SYK) + announced that it launched the PROstep MIS Lapidus fixation system for bunions.

Kalamazoo, Michigan-based Stryker designed the system to treat bunions using a minimally invasive surgical reduction. It uses the hallux valgus deformity and subsequent fusion of the first metatarsal cuneiform joint.

Traditionally, surgeons performing Lapidus bunion procedures use an open approach. Stryker cites surgeon and patient advantages with minimally invasive techniques, though. PROstep MIS Lapidus offers powerful fixation stability through a minimal incision.

The new technology features MIS joint preparation, triplanar reduction and a three-screw construct that creates a tension band for biomechanical stability.

Stryker highlights benefits including a 2.5% decrease in recurrence compared to open Lapidus procedures. The company saw a 9% reduction in …

These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…