Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal denervation (RDN) system has become the first of its kind to receive market approval from China’s National Medical Products Administration (NMPA). The company celebrates this milestone, which positions it at the forefront of the RDN technology sector in China.
While the approval is a significant achievement, Medtronic has indicated that the Symplicity system must undergo the provincial registration process before it can be widely commercialized, suggesting that sales in the short term will be modest.
The Symplicity Spyral system is designed to treat hypertension through a minimally invasive procedure that delivers radiofrequency energy to target overactive nerves near the kidneys, which are responsible for high blood pressure. The procedure involves sedation, the insertion of a catheter into the renal artery, and the application of radiofrequency pulses to ablate the nerves in the arterial walls without causing damage. Each ablation lasts approximately 1-2 minutes, and the reduction in nerve activity subsequently helps to lower blood pressure.
Globally, the Symplicity Spyral system has already gained approval in over 70 markets, including the United States. Additionally, it has been granted early access to Chinese patients through the Greater Bay Area policy, highlighting Medtronic’s commitment to addressing hypertension in China.- Flcube.com
