FDA-cleared investigator-initiated pre-marketing clinical trial of the LAA Lambre™ Plus Closure System Obtained medical insurance coverage in the United States
Shenzhen, China, September 5, 2022 /PRNewswire/ — LifeTech Scientific Corporation (stock code: 1302.HK) is pleased to announce that the August 30, 2022an investigator-initiated, FDA-cleared, pre-marketing clinical trial of its proprietary Lambre™ Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in United Stateswhich means that all patients enrolled in the clinical trial will be fully covered by the UNITED STATES medical insurance. This should facilitate the process of marketing and registering the innovative device in United States and provide strong clinical data to support the development of the device in the global market.
The investigator-initiated pre-marketing clinical trial received FDA approval in March 2022. This prospective, randomized, controlled, multicenter clinical trial aims to evaluate the safety and efficacy of implanting the LAA Lambre™ Plus occlusion device in patients with non-valvular atrial fibrillation with large and/or irregularly shaped appendages, compared to oral anticoagulants. The trial plans to enroll more than 3,000 subjects from up to 75 research sites in United States and undertake more than 1,500 implantations of the LAA Lambre™ Plus obturators for a fee. After meeting the established clinical objectives and conditions, the company will submit the device marketing application to the FDA.
“This is an important milestone in LifeTech’s international roadmap. Our LAA obturators have been successfully implanted in United States on a “compassionate use” basis, providing a novel treatment for patients with nonvalvular atrial fibrillation with irregularly shaped appendages. Today, the approval of the very first UNITED STATES Investigator-initiated pre-marketing clinical trial and medical insurance coverage give us greater confidence to further accelerate our process of delivering this innovative, safe and effective stroke prevention solution to patients in the United States. United States,” said Mr. Xie Yuehui, Chairman and CEO of LifeTech Scientific Corporation.
About the LAA Lambre™ Plus Closure System
The LAA Lambre™ Plus Closure System is independently developed by LifeTech Scientific Corporation. The device closes the patient’s left atrial appendage through a percutaneous occlusion procedure to prevent strokes caused by detachment of the thrombus from the left atrial appendage. The LAA LAMbre™ Plus Closure System is a structurally optimized version of the LAA LAMbre™ 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 more than 40 countries with nearly 20,000 cases in clinical application worldwide.
About LifeTech Scientific Corporation:
Founded in 1999, LifeTech Scientific Corporation (1302.HK) is engaged in R&D, manufacturing and sales of minimally invasive interventional medical devices for cardiovascular and peripheral vascular diseases. The company has a comprehensive product portfolio in the treatment of structural heart disease, peripheral vascular disease, bradycardia, neurological, neoplastic and respiratory diseases, as well as 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 more than 100 countries and regions, the company is currently one of the few domestic enterprises in China with a highly internationalized business. company structure.
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