Medtronic gets approval to sell renal denervation device in China

Medtronic has secured the first approval for a renal denervation system from China’s National Medical Products Administration (NMPA). This approval allows Medtronic to proceed with the provincial registration process, targeting China's 245 million individuals with high blood pressure.

The Symplicity Spyral hypertension device is expected to achieve modest sales initially in China, where local companies are also developing rival renal denervation systems.

Medtronic's system utilizes a catheter-based approach, delivering radiofrequency energy to calm overactive nerves near the kidneys, thereby reducing blood pressure. Although Medtronic gained FDA approval for Symplicity Spyral in November, European clearance for renal denervation was granted over a decade ago but was considered investigational until 2023.

After entering European and U.S. markets last year, Medtronic has now obtained authorization in China. The company plans to navigate the provincial registration process to make the device available to Chinese patients, with expectations of modest short-term sales.