Medtronic’s Symplicity Spyral RDN System Approved in China

May 6, 2024—Medtronic announced it received approval from the National Medical Products Administration (NMPA) in China for its Symplicity Spyral renal denervation (RDN) system.

The company stated it intends to go through the provincial registration process and expects sales of Symplicity Spyral in China to be modest in the short term. The Symplicity Spyral RDN 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.

Medtronic noted that hypertension is one of the most prominent public health challenges in China, with > 245 million people affected by the condition. Only 13.8% of those living with hypertension in China have their condition under control.

The company press release explained that the Symplicity Spyral has shown a mean reduction in patient office-based systolic blood pressure of 9 mm Hg at 3 months, 9.9 mm Hg at 6 months, and 18 mm Hg at 3 years, with sustained blood pressure reductions in > 1,500 patients. Additionally, there have been very low rates of adverse events.

Symplicity also demonstrated improved blood pressure control with significantly more time in treatment range after radiofrequency RDN when compared to sham through 3 years, stated the company.

According to Medtronic, the Symplicity Spyral RDN system is approved for commercial use in > 70 countries around the world. The NMPA approval comes shortly after Medtronic announced FDA approval for the Symplicity Spyral system as well as the launch of the technology in India and Canada. The device is currently limited for investigational use in Japan.