NMPA approved Medtronic’s Symplicity Spyral Renal Denervation System, the disposable multipolar renal artery radiofrequency ablation catheter and renal artery radiofrequency ablation device, according to a notice released on April 30, 2024.
“The approval positions Medtronic to begin working through the provincial registration process and target some of the more than 245 million people in China with high blood pressure”, said Medtronic in an announcement.
What’s the Device
Medtronic’s renal denervation system is a catheter-based treatment to lower blood pressure by delivering radiofrequency energy to calm overactive nerves near the kidneys.
The disposable multi-pole renal artery radiofrequency ablation catheter consists of an electrode array, catheter, catheter handle, catheter connection cable, and straightening tool, while the renal artery radiofrequency ablation device consists of a generator, remote controller, power cord, and DVI-D cable. These two products are used together. The radiofrequency ablation device can transmit radiofrequency energy through the catheter electrode to the intima of the renal artery blood vessel, utilizing the thermal effect of the electric current to deactivate the sympathetic nerves surrounding the renal artery blood vessel, blocking the excitatory conduction of sympathetic nerves, and achieving the purpose of lowering the patient’s blood pressure.
This product lowers blood pressure by physically blocking the excitatory conduction of sympathetic nerves. Compared with traditional drug treatment methods, it effectively avoids the influence of factors such as patient compliance and drug half-life, providing a new auxiliary treatment method for patients with refractory hypertension.
GBA Usage before National Approval
The renal denervation device was enrolled in the fifth batch to pioneer the clinical use in GBA (Greater Bay Area) on September 7, 2023, along with other three drugs and three devices. The first patient was treated with the system on November 16, 2023. “With support of the Urgent Usage Program, Medtronic’s RDN technology is expected to achieve rapid development and promotion in the GBA before obtaining national approval, thus providing more optimal clinical treatment options for hypertension patients with poorly controlled blood pressure.” Guangdong MPA said in the notice.
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing. These nine cities are applicable of urgent use policy for medical devices and drugs starting in May 2021.
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated.
For the latest update on the GBA policy, please click HERE
Huge Market in China
A recent study of hypertension in China, which Medtronic cited in the announcement, estimated that 245 million people in China have hypertension. Meanwhile, the World Health Organization said more than 270 million have hypertension, adding that only 14% have it under control and some people lack access to treatment.
