Medtronic’s Symplicity Spyral Renal Denervation System Approved in China

Medtronic announced today its receipt of approval from China’s National Medical Products Association (NMPA) for its Symplicity Spyral renal denervation (RDN) system.
 
Symplicity Spyral is the first RDN technology to obtain approval from the NMPA. Medtronic said it plans to go through the provincial registration process and sales to be modest in the short-term.
 
The NMPA approval comes after U.S. Food and Drug Administration (FDA) approval six months ago. Health Canada approval followed earlier this year. It’s limited to investigational use in Japan.
 
“As the leader in renal denervation, we are looking forward to bringing the Symplicity blood pressure procedure to China, where high blood pressure rates continue to increase,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “As these rates continue to climb, the need for innovative, alternative treatments is strong. The Symplicity procedure can provide people in China with another potential option when seeking high blood pressure solutions, complementing lifestyle modifications and medication.”

More about the Symplicity blood pressure procedure

The minimally invasive procedure delivers radiofrequency energy to calm nerves near the kidneys that can become overactive and cause hypertension.
 
After the patient is sedated, a catheter is inserted into the artery that leads to the kidney. Once the tube is in place, energy is administered to the system to calm the excessive nerves by the kidney. The tube is then removed, without leaving an implant behind.