RDN Archives - Medical Design Sourcing

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 …

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…

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…

Engineers wanted: ReCor Medical’s hiring as its RDN system awaits FDA approval

ReCor Medical’s Paradise renal denervation catheter uses heat (depicted by the red ring) from ultrasound-generated energy for denervation, while cooling with circulating water (depicted by the blue rings) within the artery to protect it from heat. [Illustration courtesy of ReCor Medical]

ReCor Medical is hiring as its Paradise ultrasound renal denervation (RDN) system seems set for regulatory approval following this week’s favorable vote by an FDA review panel.

The Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted in support of the Paradise system’s safety, efficacy and risk/benefit profile for patients with uncontrolled hypertension.

Such a vote is usually a precursor to FDA premarket approval (PMA). The same panel of experts dashed Medtronic’s hopes of securing a PMA for its competing Symplicity Spyral RDN system the following day.

If…

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…