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Medtronic’s renal denervation system receives approval in China

Medtronic has revealed that its Symplicity Spyral renal denervation system has secured approval from the National Medical Products Administration (NMPA) in China.

This marks a significant milestone as Symplicity Spyral becomes the inaugural renal denervation (RDN) system for treating high blood pressure to gain approval from China’s NMPA. The company has outlined plans to navigate the provincial registration process and anticipates initial sales of the RDN system in China to be conservative.

The approval follows Medtronic’s FDA approval for Symplicity Spyral about six months earlier, making it the second company in the U.S. to obtain premarket approval for an RDN system. Additionally, in March of this year, the system received licensing from Health Canada.

“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,” Jason Weidman, SVP and president of the Coronary and Renal Denervation business within Medtronic’s Cardiovascular Portfolio, said in a news release. “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.”

 

© Medtronic Plc.

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