ReCor Medical Archives - Medical Design Sourcing

January 2024 edition: The Leadership in Medtech issue

Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

How Recor Medical won the renal denervation race for FDA approval

Medtech’s biggest personnel moves of 2023

Leadership and innovation in medtech

Creativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN).

You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor.

Our annual Leadership in Medtech issue of Medical Design &a…

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…

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…

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…

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…

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…

Is renal denervation back as a high blood pressure treatment?

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

Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system.

The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its own positive renal denervation study at the American College of Cardiology’s 70th Annual Scientific Session.

Together, the new research suggests that renal denervation could be back as a promising medical technology in the cardiovascular space — half a decade after Medtronic announced a major clinical trial had failed to meet its efficacy endpoint. Since the Symplicity HTN-3 study’s failure, Medtronic…

ReCor Medical has positive renal denervation study news

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‘s renal denervation significantly reduced blood pressure among people with drug-resistant hypertension, according to a new study reported at the American College of Cardiology’s 70th Annual Scientific Session.

The study news, announced yesterday, could suggest a turnaround in fortunes for renal denervation technology. One considered the next big thing in the medical device industry, renal denervation took a hit in the middle of the 2010s when Medtronic announced a major clinical trial had failed to meet its efficacy endpoint.

Medtronic, though, has since sought trial designs that…