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 Advisory Committee voted that the Spyral system’s risks outweighed its benefits. A day earlier, the same experts recommended approval of Recor Medical’s competing technology“Medtronic has always believed in the potential of this therapy,” Medtronic SVP and Coronary and RDN President Jason Weidman said in a news release today. “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,” he continued. “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.”
Medical Design & Outsourcing: Medtronic’s Jason Weidman explains renal denervation
More than 1.2 billion people worldwide are estimated to have hypertension, but most don’t have it under control, leading to heart attacks, strokes, kidney damage and premature deaths.
Medtronic’s minimally invasive system uses a four-electrode radiofrequency catheter inside the renal arteries to ablate overactive nerves in the artery walls, lowering blood pressure.
The FDA approved the Symplicity Spyral system “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.”
That indication is the same as the one the FDA approved for Recor Medical, but different than Medtronic’s proposed indication in its PMA submission.
Medtronic’s proposed indication was 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.”
Experts on the FDA’s review panel took issue with that language as not closely enough linked to the results of Medtronic’s clinical studies. Medtronic’s clinical trials studying the safety and efficacy of its RDN technology over the years have failed to hit their primary endpoints for efficacy.
But Medtronic’s trials have demonstrated the system’s safety, making it a tough call for the FDA’s review panels.
Medical Design & Outsourcing: How Recor Medical won the renal denervation race for FDA approval