On May 31, Hangzhou Qiming Medical Devices Co., Ltd. (hereinafter referred to as “Qiming Medicalâ€) officially announced the launch of “China's first transcatheter prosthetic valve Venus A-valveâ€, marking a new era of interventional therapy in China.
Previously, the product has been approved by the CFDA (registration number: National Machinery Note 20173460680), on April 28, 2017, CFDA posted a message on its website, “Approving the innovative products produced by Hangzhou Qiming Medical Devices Co., Ltd.†Percutaneous interventional prosthetic heart valve system 'registration.'
According to the approval document, the product consists of an aortic valve and a delivery system. The delivery system consists of a delivery catheter system and a compression loading system. The aortic valve is made of a nickel-titanium valve, a gold marker, a suture, and a three-leaf made of pig pericardium. The leaflets and skirts are composed. It is indicated for patients who are considered to have symptomatic, calcified, severe aortic stenosis after a cardiac team-based scoring system and are not suitable for conventional surgical replacement valves. This product is a prosthetic heart valve that does not require direct vision and is implanted under non-cardiopulmonary bypass. It is the first self-expanding percutaneous interventional prosthetic heart valve in China, which is brought to patients who are not suitable for conventional surgical replacement valves. Significant clinical benefit.
According to relevant statistics, in China, there are about 1.5 million people over 75 years old suffering from severe aortic stenosis. For this disease, the conventional treatment is to replace the valve with surgery. Surgery, and many patients who need to replace the heart valve, due to age, some people can not afford the risk of surgery and surgery, thus giving up the routine surgery.
Qi Zhenjun, CEO of Qiming Medical, said, “Our surgical approach does not require opening the chest. Just put a hole in the thigh and implant it into the heart through the blood vessel. Obtain approval from the State Food and Drug Administration for our products. It is also a certainty."
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