Also known as the Symplicity blood pressure procedure, Symplicity Spyral treats high blood pressure, or hypertension. The first procedure follows the landmark approval for the system earlier this month.
Approval made Medtronic the second company with such approval, following Recor Medical’s nod earlier this month. There had previously been question marks over whether the medtech giant would receive approval after an FDA panel voted that the Spyral system’s risks outweighed its benefits.
However, the now-approved system was used in the first procedure at Piedmont Atlanta Hospital, Medtronic said in a news release. Dr. David Kandzari, chief of Piedmont Heart Institute and Cardiovascular Services, performed the procedure. Kandzari also served as lead principal investigator on the SPYRAL HTN-ON MED clinical trial for the system.
“We are thrilled to announce the U.S. launch of the Symplicity Spyral RDN system for patients with hypertension – and Dr. Kandzari couldn’t have been a better choice for our first U.S. procedure,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “This milestone brings potential hope to millions of Americans who might want another treatment option – other than medication and lifestyle changes – to better manage their blood pressure.
“We want to acknowledge everyone who has continued to back this therapy along the journey, and we’re excited to for the future of hypertension care.”
Weidman spoke to MassDevice about what comes next for Medtronic following this approval. READ HERE.
More about Medtronic Symplicity Spyral
Symplicity Spyral delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure. These nerves can become overactive and contribute to high blood pressure.
After sedation, a doctor inserts a catheter that can treat a range of vessel sizes into the artery leading to the kidney. The doctor then administers energy to calm the excessive activity of the nerves connected to the kidney. Then, the doctor removes the catheter, leaving no implant behind.
Medtronic received approval for the procedure as an adjunctive treatment in patients with hypertension when lifestyle changes and medications do not adequately control blood pressure. The system holds approval for commercial use in more than 70 countries around the world. It remains investigational in Japan, China and Canada.
“It’s an exciting opportunity to begin this new chapter of hypertension treatment with the first U.S. procedure using the Symplicity Spyral RDN system,” said Dr. Kandzari. “For people with hypertension, medication and/or lifestyle changes can help reduce blood pressure, but studies have shown that many people still don’t gain control over their condition. I am inspired by the potential of this complementary therapy to help treat the issue of high blood pressure for so many patients. We look forward to the future of hypertension care with this milestone.”
