Spyral ™ Gains FDA Approval

Symplicity Spyral renal denervation probe

Medtronic plc says the US FDA has approved the Symplicity Spyral renal denervation (RDN) system as an adjunct to the treatment of hypertension. Commercialization will follow, rounding off the best part of a decade since the company’s first sham-control study failed to reach its primary efficacy endpoint. That study was pretty calamitous for the then-burgeoning investments in Renal Denervation. In fact many big players chose to withdraw from the RDN arms race.

Spyral RDN

Medtronic’s press release talks of hypertension as the leading “modifiable” cause of heart attack, stroke, and death. Despite available medications and lifestyle interventions, control rates remain low.

Going back well over a decade, the medical technology industry community was presented with an opportunity. “Renal denervation” (or RDN) looked like something of a goldilocks zone for participants. A massive unmet need coincided with a promising therapeutic answer. Major players including Covidien, Boston Scientific, St Jude Medical and of course Medtronic were on board. All had acquired or developed technological approaches to RDN. Alternatives included thermal, radio frequency and ultrasound targeting of the nerves around the renal arteries.

By reducing nerve activity in this area, studies showed reductions in hitherto resistant hypertension. Indeed studies were yielding ~30mmHg falls in systolic blood pressure. That was until a few studies started to shed some doubt. Then came the bombshell that was Medtronic’s own Symplicity HTN-3 study. This was the first in which untreated patients also undertook a sham intervention. Effectively blinding the blood pressure tester to the treatment seemingly rendered the outcome less significant and the therapy was called into question. Explanations and issues such as ambulatory vs office testing and the use of older, single electrode device in HTN-3 only served to cloud the picture.

Spyral makes it two (FDA approved RDN systems)

Fast forward almost a decade and RDN is back. First came FDA approval for ReCor Medical’s Paradise™ Ultrasound Renal Denervation, as announced here last week. And now, supported by the Medtronic SPYRAL HTN Global Clinical Program, comes notice of approval for Medtronic’s system. This is the most comprehensive clinical program studying RDN. It represents experience from more than 25,000 patients treated globally. The study incorporates the presence and absence of medication, and covers patients with high baseline cardiovascular risk.

Of note, the Medtronic approval comes only a few months after the FDA’s original seemingly dimmer view. Medical Device Design and Outsourcing reported; “with six members voting that the benefits outweighed the risk, six voting the other way and one panelist abstaining, panel chair Dr. Richard Lange cast the deciding vote to recommend against FDA approval.” Furthermore ReCor’s clinical trial met its primary endpoint for efficacy, while “Medtronic’s RDN trials have failed to hit that target“.

Spyral Indication

Interestingly Medtronic’s new approval matches the indication of ReCor Medical’s Paradise™. The FDA has approved Symplicity Spyral to reduce blood pressure as an adjunctive treatment in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. Find more on how Medtronic’s original aspiration for an indication here.

The Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world. It is currently limited for investigational use in Japan, China and Canada,

Medtronic says commercialization in the U.S. will follow. This will round off the best part of a decade since the publication of the Symplicity HTN-3 study.

Company comments

Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic commented in the press release. He said, “Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most.

“It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension.”

Investigator comments

David Kandzari, M.D., is chief at Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. He stated “The Symplicity blood pressure procedure is safe and effective, providing significant ‘always on’ blood pressure reductions for patients.

“This landmark approval is the culmination of rigorous scientific study and clinical trials. These include long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study.”

Clinician comments

Co-principal investigator of the SPYRAL clinical program was Raymond Townsend, M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine. He added, “This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes.

“The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care. This is especially so for those patients who are desperately seeking additional approaches to get their blood pressure down.”

Source: Medtronic plc, Massdevice.com

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