LifeTech Scientific Corporation is pleased to announce that on 30 August 2022, an FDA-approved investigator-initiated pre-market clinical trial of its proprietary LAmbre™ Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in the United States, meaning that all patient enrollment of the clinical trial will be fully covered by the USA medical insurance. This is expected to facilitate the marketing and registration process of the innovative device in the United States and provide strong clinical data to support the development of the device in the global market.
The investigator-initiated pre-market clinical trial received FDA approval in March 2022. This prospective, randomized, controlled, multicenter clinical trial aims to evaluate the safety and efficacy of the implantation of LAmbre™ Plus LAA occluder in non-valvular atrial fibrillation patients with large and/or irregularly shaped appendages, as compared to oral anticoagulants. The trial is planning to enroll more than 3,000 subjects from up to 75 investigational sites in the United States and undertake more than 1,500 implantations of the LAmbre™ Plus LAA occluders at a fee. After reaching the established clinical objectives and conditions, the company will submit the marketing application of the device to the FDA.
"This is a great milestone in LifeTech's international roadmap. Our LAA occluders had been successfully implanted in the United States on a basis of 'compassionate use', providing a new treatment for non-valvular atrial fibrillation patients with irregularly shaped appendages. Today, the approval for the first ever USA based investigator-initiated pre-market clinical trial and the medical insurance coverage gives us a greater confidence to further accelerate our process for providing this innovative, safe and effective stroke prevention solution to patients in the United States,"
Mr. Xie Yuehui, Chairman and CEO, LifeTech Scientific Corporation
About the LAmbre™ Plus LAA Closure System
LAmbre™ Plus LAA Closure System is independently developed by LifeTech Scientific Corporation. The device closes patient's left atrial appendage through percutaneous occlusion procedure to prevent stroke caused by detachment of thrombus from the left atrial appendage. LAmbre™ Plus LAA Closure System is a structural optimized version of the LAmbre™ LAA Closure System, which is an advanced medical device in the industry in terms of design and technology, and currently it has been widely used in over 40 countries with nearly 20,000 cases in clinical application around the world.
About LifeTech Scientific Corporation
Established in 1999, LifeTech Scientific Corporation (1302.HK) is committed to the R&D, manufacture, and sales of minimally invasive interventional medical devices for cardio-cerebrovascular and peripheral vascular diseases. The company has a comprehensive product portfolio in the treatment of structural heart diseases, peripheral vascular diseases, bradycardia, neurological, neoplastic and respiratory diseases, alongside a unique iron-based bioresorbable technology. To date, 14 of the company's products have been approved as innovative medical devices by the National Medical Products Administration, and with a global reach of over 100 countries and regions, the company is currently one of the few domestic companies in China with a highly internationalized business structure.