Medtronic has announced it received approval from the National Medical Products Administration (NMPA) in China for its Symplicity Spyral renal denervation system.
Symplicity Spyral is the first renal denervation system in China to receive NMPA approval. The company intends to go through the provincial registration process and expects sales of Symplicity Spyral in China to be modest in the short-term.
This NMPA approval milestone comes shortly after Medtronic announced both the approval from the US Food and Drug Administration (FDA) for the Symplicity Spyral system as well as the launch of the technology in India and Canada. These achievements reinforce Medtronic’s commitment to expand global access to this technology for individuals with hypertension, the company said in a press release. The Symplicity Spyral system also recently received approval under the Greater Bay Area policy in China to commercially sell the system to hospitals in the Greater Bay Area.
The Symplicity blood pressure procedure delivers radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure. After sedation, the doctor inserts a catheter into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
“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.”
