renal denervation Archives - Medical Design Sourcing

SoniVie completes enrollment in trial of ultrasound renal denervation for hypertension

The Tivus renal denervation system. [Image from SoniVie]SoniVie announced today that it treated the last patient in a pilot study of its Tivus technology for renal artery denervation to treat hypertension.

Tel Aviv, Israel-based SoniVie develops Tivus (therapeutic intra-vascular ultrasound) to treat a variety of hypertensive disorders. It’s conducting the REDUCED-1 FDA investigational device exemption study to evaluate the renal denervation technology.

The company says the last patient in the trial received treatment with Tivus on Jan. 8.

REDUCED-1 features two enrollment cohorts conducted under an identical protocol in the U.S. and Israel. It enrolled 25 patients in the U.S. and 15 in Israel. All patients are now in the follow-up phase measuring primary efficacy (change in daytime systolic ambulatory blood pressure) at three months. The study also looks at safety at one month and 12 months follow-up.

Tivus, a minimally invasive procedure uses …

How alcohol could make renal denervation for hypertension faster and simpler

Ablative Solutions President and CEO Kate Rumrill [Photo courtesy of Ablative Solutions]

Ablative Solutions is developing the Peregrine renal denervation (RDN) system to treat hypertension. The company hopes to follow Recor Medical and Medtronic in winning FDA approval for the system.

“As a small company, it’s definitely better to be a fast follower than it is to be first to market,” Ablative Solutions CEO Kate Rumrill said in an interview. “I’m excited for Medtronic and Recor and their first year of sales and having these larger companies out there, doing some of that early work as far as market awareness and market adoption.”

Medtronic’s Symplicity Spyral RDN system uses radiofrequency (RF) energy, while Recor’s Paradise system uses ultrasound. Peregrine doesn’t deliver energy at all, instead using alcohol as a neurolytic agent.

“There …

Recor Medical CEO Lara Barghout on leadership lessons and what she looks for when hiring

Recor Medical CEO Lara Barghout discusses how medtech leaders can empower and grow their teams while encouraging innovation.

Recor Medical CEO and President Lara Barghout [Photo courtesy of Recor Medical]

Recor Medical has some growing to do after winning the first FDA approval for renal denervation (RDN) to treat hypertension.

Recor President and CEO Lara Barghout said her company already has somewhere between 300 and 500 employees and plans to hire “across the board” including innovation/R&D, clinical and infrastructure roles.

Barghout — who recently spoke with Medical Design & Outsourcing about how her team beat the world’s largest medical device developers to premarket approval and commercialization of RDN — offered lessons in leadership she’s learned over her career in medtech.

At the time of publication, Recor Medical’s jobs webpage listed open roles in…

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…

Ablative Solutions hits primary endpoint in renal denervation for hypertension trial

Ablative Solutions announced today that its TARGET BP I pivotal trial evaluating its Peregrine System kit met its primary endpoint.

The trial evaluates alcohol-mediated renal denervation to treat hypertension with the Peregrine System. Wakefield, Massachusetts-based Ablative Solutions reported a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months.

TARGET BP I evaluated the safety and efficacy of Peregrine to treat uncontrolled hypertension in patients taking anti-hypertensive medications. It evaluated 301 patients randomized to Peregrine treatment or sham procedure. The study remained blinded through six months follow-up.

The kit features a patented infusion catheter and dehydrated alcohol. Patients undergo a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal arteries, reducing blood pressure.

Renal denervation has become a hot topic of late…

Medtronic execs: renal denervation for AFib could be on the horizon

The Medtronic Symplicty Spyral renal denervation (RDN) catheter delivers radiofrequency energy from four electrodes to ablate nerves in the renal arteries and treat high blood pressure. The nitinol-based device expands in a spiral pattern inside the blood vessel. [Image courtesy of Medtronic]

Medtronic renal denervation leaders Jason Weidman and Sean Salmon discuss RDN’s potential to help patients with atrial fibrillation (AFib).

As if treating an epidemic-level condition like hypertension wasn’t enough, renal denervation (RDN) also shows potential for atrial fibrillation (AFib) and other conditions related to high blood pressure.

In interviews with Medical Design & Outsourcing, Medtronic EVP Sean Salmon and SVP Jason Wediman discussed whether their Spyral Symplicity radiofrequency (RF) catheter ablation technology could help AFib patients when paired with cryoablation.

Weidman — pres…

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’…

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…

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…

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…

How Recor Medical won the renal denervation race for FDA approval

The Recor Medical Paradise ultrasound RDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. [Illustration courtesy of Recor Medical]

It’s been a long wait to see the FDA approve renal denervation for treating hypertension.

Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN system. While they were celebrating, the team learned that the very first commercial procedure had just been completed.

“After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done — they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotiona…