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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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…

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Recor Medical launches renal denervation system, announces first commercial cases

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of Recor Medical]Recor Medical announced the first commercial uses of its Paradise ultrasound renal denervation (uRDN) system for treating hypertension.

The first commercial uses follow the company’s landmark FDA approval for Paradise last week. Approval allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure.

Recor edged out Medtronic in the race to offer the first FDA-approved RDN system that treats hypertension.

The first procedures took place in New York, Ohio and in California. Dr. Ajay J. Kirtane and Dr. Sahil A. Parikh conducted proc…

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Recor Medical wins first FDA nod for renal denervation to treat hypertension

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of Recor Medical]Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension.

The long-awaited approval for the Otsuka Medical Devices portfolio company allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure.

Paradise had looked the most likely system to win approval in the race for the first FDA nod to use RDN to treat hypertension. An FDA panel voted in favor of FDA approving Paradise uRDN system in August. The same panel voted against recommending Recor’s closest competition, M…

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Recor Medical presents more data supporting its renal denervation system

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of Recor Medical]Otsuka Medical Devices’ Recor Medical announced another set of positive study results for its Paradise ultrasound renal denervation (uRDN) system.

A combined analysis of six-month follow-up data from three RADIANCE global studies evaluated Paradise as a hypertension treatment. The analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN compared to sham. It also saw fewer antihypertensive treatments added in the treatment group.

The data provides further support for the renal denervation system, which looks the most likely to garner the first FDA nod for treating hypertension. An FDA panel in Au…

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The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic faced tough questions about its Symplicity Spyral renal denervation (RDN) therapy for hypertension at today’s FDA review panel.

Medtronic is seeking approval of its Symplicity Spyral multi-electrode RDN catheter and Symplicity G3 radiofrequency generator “for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of anti-hypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.”

The stakes are high for Medtronic, which has been developing the technology for years in the belief that it could be a billion-dollar business and provide relief to millions of patients worldwide, reducing heart attacks, strokes and other serious events tied to high blood pressure.

The same FDA review…

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ReCor Medical wins FDA panel nod for its renal denervation system

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of ReCor Medical]ReCor Medical announced today that an FDA panel has voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension.

Yesterday, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor, with one vote abstaining, for the efficacy of the system to treat high blood pressure.

In addition, the committee voted 10-2 that the Paradise system’s benefits outweigh the risks. If the Paradise system secures an FDA PMA, it would be the first renal denervation device in the U.S. indicated to …

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ReCor Medical is pleased with updated renal denervation guidelines in Europe

The Paradise catheter during a renal denervation procedure. [Image courtesy of ReCor Medical]ReCor Medical today applauded updated and expanded recommendations for managing arterial hypertension overseas.

The European Hypertension Society (ESH) this month issued updated guidelines on the role of renal denervation in the hypertension care pathway. It announced the guidelines at the ESH 32nd Annual Meeting and simultaneously published them in the Journal of Hypertension.

These new guidelines serve as a resource for the latest scientific evidence in hypertension treatment. They include recommendations on the use of renal denervation, for which ReCor develops the Paradise system.

Last week, Medtronic issued a similar statement to express its excitement with the new guidelines.

“The ESH guidelines support the experience of European clinicians who are already using the Paradise Ultrasound RDN System for some patients who need an additional treatment option…

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ReCor Medical announces more positive study results for its renal denervation system

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical announced today that its Paradise ultrasound renal denervation (uRDN) system successfully reduced blood pressure in a study.

Palo Alto, California-based ReCor published primary endpoint results from its Radiance II trial in the Journal of the American Medical Association (JAMA). Results showed success for Paradise in reducing blood pressure compared to sham. Additionally, pooled analysis from multiple studies showed consistent blood pressure lowering. This took effect across a range of hypertension, including mild to moderate and resistant hypertension.

“The results of the Radiance clinical trials are meaningful in that they solidify the role of the Pa…

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RoCor Medical names Lara Barghout as CEO

 

ReCor Medical’s CEO Lara Barghout [Image courtesy of LinkedIn]ReCor Medical today announced it appointed Lara Barghout as president and CEO.

Barghout will succeed Andrew Weiss and will be responsible for leading the Palo Alto, California-based company’s business strategy and organization in a new direction – commercializing ReCor’s Paradise ultrasound renal denervation (uRDN) system that treats hypertension.

“I am honored to lead the extraordinary team at ReCor at an exciting time in the company’s growth,” Barghout said in a news release. “High blood pressure is a leading contributor to cardiovascular disease burden worldwide, resulting in increased patient risk and higher costs to health systems. I look forward to leading our focus to advance uRDN as a treatment for hypertension and the global commercialization of the Paradise uRDN System. We believe our Paradise uRDN technology to be a true game changer in improving hypertension t…

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ReCor reports more positive ultrasound renal denervation results

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical said its Paradise ultrasound renal denervation (uRDN) treatment showed consistent and significant blood pressure reductions in an analysis of pooled data from its ReCor’s three Radiance randomized hypertension studies.

“Pooling the data from the Radiance program demonstrates that treatment with the Paradise uRDN System results in a consistent reduction in blood pressure across differing severities of hypertension,” Dr. Ajay Kirtane, a co-principal investigator on the study, said in a news release. “The consistent and clinically meaningful BP reduction across multiple patient groups increases our interest in the use of uRDN as a potential the…

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