Medtronic Archives - Page 5 of 59 - Medical Design Sourcing

How Medtronic evaluates its exposure to GLP-1 drugs

Medtronic Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri drills into GLP-1 drug trial results to estimate their impact across the portfolio.

“We’ve done all the analysis” on GLP-1 drugs across Medtronic’s portfolio, said CEO and Chair Geoff Martha. [Photo courtesy of Medtronic]

The impact of glucagon-like peptide-1 (GLP-1) drugs like Ozempic and Wegovy on medtech manufacturing is one of the biggest uncertainties heading into 2024.

Industry leaders like Medtronic, Stryker and Intuitive have faced questions from investors about whether these weight loss drugs will reduce demand for certain medical devices and procedures.

Despite a portfolio spanning some of the fields that would seem likely to be affected — such as cardiovascular, diabetes, surgical and neurovascular — Medtronic Chair and CEO Geoff Martha recently said the drugs won’t impact his company’…

Are investors overreacting on AtriCure after Medtronic’s Penditure launch?

The Penditure (left) and AtriClip (right) devices. [Images courtesy of Medtronic and AtriCure]BTIG analysts say a small survey of surgeons may indicate an oversell of AtriCure stock following Medtronic’s launch of a competing device.

Medtronic this week launched the Penditure left atrial appendage (LAA) exclusion device, adding another system to a competitive space. AtriCure, Abbott and Boston Scientific all offer LAA devices, while Johnson & Johnson MedTech just made its own play in the market.

AtriCure took the biggest hit as a result of the Medtronic launch, with stock falling nearly 20%. The reaction comes as a result of AtriCure’s makeup, with the AtriClip LAA device making up around a third of its revenue, according to BTIG.

The Penditure and AtriClip are quite similar devices. Both are meant for accompanying use with another heart surgery procedure. The situation leads to question marks over how the former’s launch affects the l…

Medtronic reports first patient treated with Symplicity Spyral renal denervation system

The Medtronic Symplicty Spyral renal denervation ablation catheter expands inside the renal arteries and ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic (NYSE: MDT) + announced that doctors completed the first commercial case in the U.S. with its Symplicity Spyral renal denervation (RDN) system.

Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month.

Approval made Medtronic the second company with such approval, following Recor Medical’s nod earlier this month. There had previously been question marks over whether the medtech giant would receive approval after an FDA panel voted that the Spyral system’s risks outweighed its benefits.

However, the now-approved system was used in the first procedure at Piedmont Atlanta…

Medtronic launches left atrial appendage exclusion system

The Penditure left atrial appendage (LAA) exclusion system [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it launched its Penditure left atrial appendage (LAA) exclusion system in the U.S.

Penditure, an implantable chip, comes pre-loaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures. Medtronic designed it with a curve to better match atrial anatomy and without fabric for atraumatic closure and reduced inflammation. The company acquired the device from Syntheon in August of this year. It received FDA clearance that same month and is available in the U.S. on a limited basis.

The medtech giant says its device is the only LAA clip that can be recaptured, repositioned and redeployed after deployment during a procedure. This puts greater control in the hands of surgeons. Noteworthy competitors in the space include Abbott’s Amplatzer Amulet, Bost…

What’s next for Medtronic’s RDN program after FDA approval

The Medtronic Symplicty Spyral renal denervation ablation catheter expands inside the renal arteries and ablates nerves in the vessel wall to treat hypertension. [Illustration courtesy of Medtronic]Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension.

In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the first commercial cases to be performed this week.

“We’ve got a full team out there that’s ready to go,” Weidman said. “We’ll be leveraging our coronary sales force, which obviously has close relationships and familiarity with the physicians that do these procedures and they’re well-versed on renal denervation.”

Medtronic also has a field market development…

What Medtronic learned on its long road to RDN approval

Medtronic SVP and President of Coronary and Renal Denervation Jason Weidman [Photo courtesy of Medtronic]

It took Medtronic nearly 13 years to win FDA approval for renal denervation (RDN) since buying Ardian and its hypertension-treating technology.

Jason Weidman, the Medtronic SVP who is also president of coronary and RDN, has a more personal measure of the long road to approval for the world’s largest medical device manufacturer.

“The first meeting that I had with the startup Ardien, my daughter was a newborn — and she started high school this year,” he said in an interview with Medical Design & Outsourcing.

This month, the FDA approved an RDN system developed by Recor Medical, and followed soon after with approval for Medtronic’s Symplicity Spyral RDN system. Both RDN systems treat hypertension by calming overactive nerves in the renal arteries with a minimally invas…

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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Breaking new ground in medtech

This year has brought a flurry of firsts from medical device manufacturers as they develop new and improved products despite continued supply chain and economic challenges.

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All of these industry players have come together once again in our latest edition of the Medical Design & Outsourcing Medical Device Handbook to offer uniquely relevant and actionable advice for device designers and engineers.

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Medtronic’s mid-single digit revenue growth continues

Medtronic (NYSE: MDT) + today reported second-quarter results that beat the Wall Street analysts’ consensus, with the world’s largest medtech company reporting strength across businesses and geographies.

Along with a raised full-year guidance, the news sent MDT shares up more than 4% to $78.74 apiece by afternoon trading today. MassDevice‘s MedTech 100 Index was up slightly.

The positive earnings came on the heels of some important regulatory approvals for Medtronic. Right before the weekend, the FDA approved the company’s Symplicity Spyral renal denervation system for treating hypertension — which company officials think could open up a multibillion-dollar market. Yesterday, the company received a CE mark for its PulseSelect pulsed field ablation system — another technology generating excitement.

In addition, the turnaround of Medtronic’s diabetes business continues seven months after it…

Medtronic pulsed-field ablation system wins CE mark

The PulseSelect pulsed field ablation system [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + said today that it’s received a CE mark for its PulseSelect pulsed field ablation system.

In addition, the medtech giant received European Union approval for its Nitron CryoConsole, which builds upon the legacy of the company’s cryo franchise with features to optimize the workflow for cryoballoon ablation.

The news of the regulatory wins in the EU comes about eight months after the medtech giant received a CE mark for its Affera mapping and ablation system, which offers both pulsed field and radiofrequency ablation.

Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation (AFib) is treated. Companies including Medtronic, Boston Scientific, Johnson & Johnson’s Biosense Webster and more are competing to get PFA system…

‘A safe pair of hands’ — Medtech’s investment in Ireland continues to grow

Killilagh, Ireland. [Image by Sean Whooley]Medtech established its presence in Ireland many years ago and still, companies continue to invest in the ever-growing country.

Boston Scientific established operations in Ireland in 1994, while Abbott has more than 70 years in the country. Medtronic, now officially headquartered in Dublin, has spent more than 40 years in Ireland and even hosted its 2023 annual meeting in the country.

Those companies, plus many more, continue to invest in Ireland, while more big names in medtech are coming to the table. Dexcom, for instance, earlier this year chose Athenry as its first European manufacturing location with a more than $325 million investment.

Speaking to MassDevice, Dexcom EVP of Global Operations, Barry Regan, explained what attracted the company to the growing medtech hub.

“One way I would describe Ireland when it comes to medtech operations and manufacturing is it’s a safe pair of hands,”…

FDA approves Medtronic’s Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation catheter [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension.

A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic is now the second company with premarket approval (PMA) to market an RDN system for hypertension in the U.S., following Recor Medical’s approval earlier this month.

Medtronic said it plans to immediately commercialize its system and the Symplicity blood pressure procedure.

Medtronic leaders have said RDN therapy could be a multibillion-dollar market, but it wasn’t clear whether the Spyral Symplicity system would get the green light from regulators.

This summer, medical and statistical experts on the FDA’s Circulatory System Devices Panel of the Medical Devices Advisor…