(Yicai) Sept. 11 -- China's Hanyu Medical Technology has gained the green light to bring the first domestically developed device for a minimally invasive procedure to fix a leaky mitral valve in the heart to replace imported products.
Hanyu's ValveClamp, a system that can be compared to Abbott Laboratories' MitraClip, is permitted to enter the market, the National Medical Products Administration said on its website recently.
China has around 10 million patients with mitral valve regurgitation, one of the most common heart diseases where the valve does not close properly and therefore allows the blood to flow backward which can cause fatigue and arrhythmia. Before doctors could install transcatheter mitral valve repair devices through a vein without touching the chest they used to have to carry out a major surgical procedure such as thoracotomy which caused higher risks and slower recovery.
ValveClamp is expected to enter hospitals in early 2024 for clinical use, Yicai learned from Shanghai-based Hanyu's research and development team. Compared with imported products, the system is easier to use, the procedure does not expose the patient to radiation, and the operational range of the product is wider.
The original design patent of ValveClamp belongs to Professor Ge Junbo from Zhongshan Hospital affiliated with Fudan University while Hanyu is in charge of making the product commercial. ValveClamp has already been used for clinical research in dozens of hospitals in China over the past two years.
A medical device expert said to Yicai that the commercial success of any medical device depends on the scale of the market. For TMVR, the market is still being explored as China has so far installed about 1,200 MitraClips.
Each imported TMVR device costs over CNY300,000 (USD41,420), and hospitals do not widely stock them so the use is low, Prof. Pan Wenzhi, a core developer of ValveClamp from Zhongshan Hospital, told Yicai. However, the market is resilient and excellent medical devices can create greater market demand, Pan added.
Editors: Tang Shihua, Emmi Laine