Sichuan University Develops First Domestic Balloon-Expandable Transcatheter Aortic Valve System
TapTechNews August 23rd news, according to the official news of Sichuan University on the evening of August 22nd, recently, the Transcatheter Aortic Valve System led by the team of Professor Chen Mao from the Cardiology Department of West China Hospital of the university was approved for listing by the National Medical Products Administration.
As the first domestically-produced and independently developed balloon-expandable transcatheter aortic valve product to be listed, the Transcatheter Aortic Valve System can greatly reduce the financial burden for patients with heart valve diseases, and also marks that the treatment level of heart valve diseases in China has once again reached the international advanced level.
The Transcatheter Aortic Valve System was developed by the team of Professor Chen Mao in cooperation with a Shanghai medical technology enterprise for 8 years, and is suitable for patients who are considered to have symptomatic, calcified, severe degenerative native aortic valve stenosis after being evaluated by the cardiac team combined with the scoring system, and are not suitable for receiving regular surgical valve replacement, patients aged 70 or older.
The product consists of a transcatheter aortic valve, a transcatheter aortic valve delivery system (including a delivery device and a valve loader), an aortic valve balloon dilation catheter, a crimping device and a balloon inflation device. Under the monitoring of medical imaging equipment, this product is implanted into the human aortic annulus through the femoral artery via a catheter, replacing the original diseased aortic valve and improving the stenosis at the lesion site and cardiac function.
TapTechNews found out that aortic valve stenosis (AS) is one of the most common heart valve diseases. At present, the treatment options for patients with aortic valve stenosis mainly include two types: surgical valve replacement through open chest surgery (SAVR) and transcatheter aortic valve replacement (TAVR). Compared to SAVR, TAVR does not require open chest and cardiopulmonary bypass, and has the advantages of less trauma and faster recovery, providing a safer treatment method for high-risk surgical patients. Among them, TAVR can be roughly divided into balloon-expandable and self-expanding types, each with its own characteristics. Before this, all the interventional aortic valve replacement products developed in China adopted the self-expanding technical route.
The product is benchmarked against the latest generation of balloon-expandable valve technology, adopting a balloon-expandable short-stent valve design, and has made innovations in many aspects such as the valve stent, valve skirt, and delivery system:
The valve stent uses a cobalt-chromium alloy, and the radial support force it generates can compress the residual valve to a smaller size;
The unique biological tissue treatment technology can further improve the service life of the valve;
The inner and outer sealing membrane valve skirt design can effectively reduce perivalvular leakage;
The delivery system has more excellent bending adjustment performance, making the aortic arch passage better during the operation, effectively reducing the damage to the blood vessel wall and achieving accurate positioning.
The official of Sichuan University said that relying on the Biomaterials & Medical Device Technology Innovation Joint Laboratory jointly built with enterprises, giving full play to the advantages of clinical technology of West China Hospital of the university and the research foundation in biomaterials, led by the team of Professor Chen Mao, in cooperation with the National Engineering Research Center for Biomaterials, and conducting multi-center clinical trials in the cardiac centers of nine large third-class hospitals including West China Hospital of our university, through the integration of medicine and engineering to整合 resources and jointly overcome the bottleneck key technologies, independently developed the first domestic balloon-expandable interventional aortic valve, filling the gap in this field in China.