Shanghai, China – 19 May, 2015 - Dongguan Kewei Medical Instrument Co ("Dongguan Kewei") received the registration certificate for its Ventricle Septal Defect Occluder ("VSD Occluder") from China Food and Drug Administration ("CFDA").
This product is designed for interventional treatment of congenital heart ventricle septal defect. Once placed in the lesion, the VSD Occluder effectively blocks abnormal blood flow so as to repair or rebuild the defect.
The VSD Occluder uses curved-surface double-umbrella design, which makes it more stable and unlikely to drop off. It is proved to be safe and reliable as it passes 400 million times of durability evaluation. It uses a special connection design and welding technology to reduce the risk of the occluder being disconnected from the delivery system in the delivery process. High-quality Nitinol material with intensive heating processing ensures its excellent superelasticity, biological compatibility and the ability of shape memorizing, which enables the occluder to deliver smoothly and to deploy completely when released.
Aside from the VSD Occluder, Dongguan Kewei also offers PDA Occluder, ASD Occluder and Occluder Delivery System, all with CFDA approval. With a more diversified product offering, Dongguan Kewei will provide better service to patients with congenital heart diseases.