FDA approves another renal denervation system for hypertension

The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Symplicity Spyral renal denervation (RDN) system for hypertension. This is the second RDN system to ever gain FDA approval for the treatment of hypertension. Recor Medical’s Paradise Ultrasound RDN system received the greenlight in early November.

Medtronic’s Symplicity Spyral RDN system treats hypertension through the use of four radiofrequency ablation electrodes attached to a single catheter. The FDA reviewed data from multiple clinical trials, including SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, when making its decision.

“Medtronic has always believed in the potential of this therapy,” Jason Weidman, senior vice preside and president of Medtronic’s coronary and renal denervation business, said in a statement. “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.”

Medtronic has already gained CE mark approval to sell and market the Symplicity Spyral RDN system in Europe. With FDA approval acquired, the company expects to move forward with commercialization in the United States right away.

Approval comes 3 months after FDA panel voted not to endorse the Symplicity Spyral RDN system

This approval came as a bit of a surprise. An FDA advisory panel voted not to endorse the Symplicity Spyral RDN system in August. The panel voted 13 to 0 that the device was safe to use for patients with uncontrolled hypertension, and it voted 7 to 6 that the device was effective for treating the intended patient population. However, the group could not agree that the RDN system’s benefits outweigh any potential risks.

Julia B. Lewis, MD, a professor of medicine with Vanderbilt Health, was one of the panel members who had concerns about the Symplicity Spyral system’s ability to improve outcomes. She voted that its benefits did not outweigh its risks.

“I think we have to be cautious not to confound the desperateness of the unmet need with a willingness to throw anything at that unmet need,” she said at the time. “It’s not going to help people’s blood pressure and their cardiovascular outcomes to have a procedure that is potentially either ineffective or minimally effective.”