On 24 December 2020, LAmbreTM Left Atrial Appendage (LAA) Closure System (the Device), developed by LifeTech Scientific Corporation (the Company), has obtained the approval by the US Food and Drug Administration (“FDA”) for the commencement of an investigator-initiated clinical trial (“Trial”) in the US. The primary objective of the Trial is to demonstrate the safety and efficacy of the implantation of the Device in non-valvular atrial fibrillation patients with large and/or irregularly shaped appendages who are at increased risk for stroke and systemic embolism. The Company will charge a reasonable price for the Device. It is expected to provide clinical evidence to facilitate the market-entry process for the Device in the US market.
LAmbre™ LAA Closure System has been self-developed by the Company over the past decade and has advanced in product design and technology within the industry. The product has a very comprehensive global patents protection, and its quality control system is stringently in line with the international standards. Currently, the Device has been widely used in the Chinese and European markets and it has been successfully entered into the other core markets including Southeast Asia, Latin America, Middle East and Africa.
The obtaining of US FDA approval for the Trial will provide clinical data to further prove the safety and efficacy of the Device, and it is expected to provide an innovative, safe and efficient stroke prevention solution for non-valvular atrial fibrillation patients with irregularly shaped appendages in the North American.