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 …

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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…

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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…

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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…

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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…

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After Medtronic’s latest setback, what’s next for Symplicity Spyral RDN?

Medtronic’s Symplicity Spyral device is a multi-electrode radiofrequency catheter for renal denervation. [Image courtesy of Medtronic]

Medtronic’s Symplicity Spyral renal denervation (RDN) system for treating hypertension seems less likely now than ever to win FDA approval after yesterday’s vote Circulatory Systems Devices Panel vote.

The panel’s medical and statistical experts voted against recommending approval of Medtronic’s RDN therapy for hypertension under the proposed indications. While they supported approval of ReCor Medical’s competing RDN system one day earlier, a key difference was the failure of Medtronic’s RDN system to outperform hypertension drugs.

Medtronic acquired the technology through its takeover of Ardian in January 2011. Early clinical results were promising, but Medtronic announced in 2014 that its Symplicity HTN-3 trial failed to meet it…

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FDA review panel questions Medtronic on Symplicity Spyral renal denervation system

Medtronic’s Symplicity Spyral renal denervation catheter 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 seriou…

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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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Ahead of Medtronic RDN’s FDA review panel, analysts place their bets

The Symplicity Spyral renal denervation system delivers radiofrequency energy via a catheter to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Analysts expect good news for Medtronic and its renal denervation (RDN) therapy for hypertension when the FDA review panel meets later this month.

RDN therapy could be a life-saver for millions of patients with high blood pressure — and a billion-dollar business for Medtronic if it wins FDA approval after two failed trials in the past decade.

The world’s largest medical device company is looking for a win after the latest RDN pivotal trial fell short of expectations, a disappointing result in a year with many other challenges. Medtronic’s revenue slipped 1% in fiscal 2023 (which ended on April 28, 2023), and net income dropped by 25% year-over-year as the company cut costs with early retirements, la…

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80-cent device prototype uses smartphone to monitor blood pressure

A 3D-printed device that clips onto a smartphone can take blood pressure readings. [Photo courtesy of University of California San Diego]

University of California San Diego engineers have prototyped an inexpensive device that clips onto a smartphone to monitor a user’s blood pressure.

The 3D-printed device uses the smartphone’s camera and flash paired with an algorithm on an app to take systolic and diastolic blood pressure readings.

“We’ve created an inexpensive solution to lower the barrier to blood pressure monitoring,” study first author Yinan (Tom) Xuan, an electrical and computer engineering Ph.D. student at UCSD, said in a news release.

Xuan published the team’s findings this week in Scientific Reports with senior author and electrical and computer engineering professor Edward Wang, who’s also director of the UCSD Digital Health Lab.

“Because of their low cost…

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The next wave: 10 promising investigational antihypertensive drugs to watch

[Image courtesy of Adobe Stock]

Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. This review highlights ten promising antihypertensive drug candidates with the potential to address pulmonary arterial hypertension (PAH), resistant hypertension and uncontrolled hypertension.

Aprocitentan, developed by Janssen NYSE:JNJ) and Idorsia (SIX:IDIA), is an experimental oral drug designed to treat resistant hypertension. As a dual endothelin receptor antagonist (ERA), it effectively blocks the binding of ET-1 to both ET A and ET B receptors. The drug has a low likelihood of interacting with other medications and its mechanism of action is well-suited for treating resistant hypertension. In clinical trials, aprocitentan demonstrated better blood pressure reduction than placebo, with the effects lasting up to week 40, and was generally well-tolerated by patients. (Text continues beneath th…

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What’s next for Medtronic RDN after Symplicity Spyral trial ‘surprise’?

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

The Medtronic (NYSE:MDT) Symplicity Spyral renal denervation (RDN) treatment’s failure to outperform hypertension drugs came as unexpected news to analysts who have been watching the industry’s efforts in the space for years.

Analysts from BTIG and Truist Securities said they have new questions about commercialization, reimbursement and physician acceptance as Medtronic seeks FDA approval for what could be a billion-dollar business.

While the Symplicity Spyral treatment for patients on blood pressure medication was demonstrated to be safe and showed a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, the treatment failed to meet its primary efficacy endpoint.


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