Medtronic Receives Approval for First RDN System

Medtronic Receives Approval for First RDN System

By, Admin 9 May 2024

Medtronic receives approval for first Symplicity Spyral Renal Denervation System in China

Overview

Medtronic has received approval from the National Medical Products Administration (NMPA) in China for its Symplicity Spyral renal denervation (RDN) system, also known as the Symplicity blood pressure procedure. Symplicity Spyral is the first RDN 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.

About Hypertension

  • Hypertension is one of the most prominent public health challenges in China, with over 245 million people affected by the condition. 
  • Further, only 13.8% of those living with hypertension in China have their condition under control. 
  • Worldwide, control rates remain low, despite available medications and lifestyle interventions. 
  • These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.

The NMPA Approval

  • This NMPA approval milestone comes shortly after Medtronic announced both the approval from the US Food and Drug Administration for the Symplicity Spyral system as well as the launch of the technology in India and Canada. 
  • 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.
  • Currently limited for investigational use in Japan, the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world.

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