Medtronic claims long-sought renal denervation approval from FDA for its Symplicity Spyral blood pressure treatment

It’s game on in the field of renal denervation, with Medtronic claiming the second FDA green light this month for a procedure to treat drug-resistant high blood pressure—a market its developers expect will ultimately grow into a multibillion-dollar enterprise.

Medtronic’s Symplicity Spyral system received agency approval after about a decade of research and development—an odyssey that had seen setbacks in early clinical trials before achieving greater success with a product redesign

Most recently, the company had its hopes dampened by a narrow loss at a dedicated FDA advisory committee meeting this past summer, where the panel voted against recommending approval for the Symplicity Spyral by a slim margin. 

The FDA has never been bound by its advisors’ recommendations, but it takes them under advisement during product reviews. In this case, the panel’s August meeting also evaluated a renal denervation approach from Medtronic’s sole U.S. competitor, Recor Medical, and gave it its blessing. Recor, a division of Otsuka Medical Devices, went on to cross the finish line first, about two weeks ago, to secure FDA approval for its Paradise system.

“Medtronic has always believed in the potential of this therapy,” Jason Weidman, president of the medtech giant’s coronary and renal denervation business, said in an announcement, which noted that the company plans to begin commercialization immediately.

“It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space,” Weidman added. “High blood pressure is a global health issue, and patients need more options to manage their blood pressure.”

Renal denervation relies on a minimally invasive procedure to address the nerves that line the blood vessels feeding the kidneys, which can send overactive neural signals to the brain and trigger hard-to-treat hypertension. Medtronic’s Symplicity Spyral aims to take the foot off the gas pedal by burning out these nerves with a radiofrequency energy-powered ablation catheter.

The system’s “always-on” effects were evaluated in long-term, sham-controlled trials that included patients both on and off their blood pressure drug regimens, as well as in a large real-world study. 

One randomized trial showed a drop of 18.7 mmHg in patients’ 24-hour systolic blood pressure readings after three years, while a control group demonstrated an 8.6 mmHg reduction. 

At the same time, patients who underwent the one-time Symplicity procedure were able to take fewer medications as the study went on. The company’s off-medication study, meanwhile, led to a 9.2 mmHg drop after three months.