VenusA-Valve is the first transcatheter aortic valve replacement system approved in China. Its unique stent design enables it to work without balloon dilation and segmental release ensures a simple and stable operation process. In particular, radial force is enhanced for the higher frequency of bicuspid aortic valve and heavy calcification in Chinese patients.
VenusA-Valve was approved by China National Medical Products Administration (NMPA) on April 25th, 2017. It is the first transcatheter aortic valve replacement system commercialized in China. VenusA-Valve has dominated the country’s TAVR segment since day one with a market share consistently above 80%.
VenusA-Plus retains the advantage of strengthened radial force of VenusA-Valve, the first-generation valve replacement system of the Company, while thoroughly optimizing the delivery system and adding retrievable and repositionable features. This would effectively decrease the difficulty, promote successful rate, and improve postoperative benefits. VenusA-Plus will shorten the learning curve of doctors and help accelerate the development and popularization of TAVR in China.
VenusA-Plus was approved by NMPA on November 10th, 2020 and was commercially applied in the same year. On December 18th, 2020, VenusA-Plus was registered and approved by the Food and Drug Administration Committee of the Ministry of Public Health of Thailand.
TriGUARD3™ is the only cerebral protection device designed to provide full coverage to the entire ascending aortic arch to minimize the risk of cerebral embolism during transcatheter aortic valve replacement (TAVR) and surgical valve replacement, atrial fibrillation ablation, and other structural cardiac procedures.
TriGUARD3™ can share the transfemoral access used in structural cardiac procedures, thereby no additional access site is required. The nitinol frame with dome-shaped mesh deflector is designed to perfectly fit various aortic arches and cover all three cerebral aortic arch vessels, i.e. brachiocephalic artery, left common carotid artery and left subclavian artery. It deflects embolic debris away from the cerebral circulation during transcatheter heart procedures. The product gives full protection to the brain to effectively prevent perioperative stroke and mortality.
This balloon aortic valvuloplasty catheter with an anatomical shape is the first of its kind in the world. TAV8 features an “8” shaped balloon narrowed in the middle with enlarged ends when fully dilated. The design enables the narrowed balloon waist to lock onto the valve opening of patients with bicuspid aortic valve disease, avoiding excessive dilatation and reducing hemodynamic instability after dilatation. Approved by CE and FDA, the device has also completed the enrollment of registered clinical trials in China.
Leaflex™ catheter performs mechanical scoring of valve calcification, restoring leaflets' mobility and improving valve hemodynamics.
The product was developed by Pi-Cardia Ltd. (Pi-Cardia), a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, and was introduced to China by Venus Medtech in September 2020. In October 2021, Leaflex™ completed its FIM (First-in-man) clinical trial in China.
The Leaflex™ catheter is designed to be a cost-effective, durable standalone treatment. It can be used for patients who are not planning to undergo transcatheter aortic valve replacement (TAVR) and it can be a means to defer TAVR in patients who may be too young for the procedure. It can also be a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves. Leaflex is also applicable for patients for those who’ve implanted a prosthetic heart valve for years. Affordable solution with short hospitalization is of great significance for patients suffering from aortic stenosis