FDA-approved Investigator-initiated Pre-market Clinical Trial of LAmbre™ Plus LAA Closure System Gains US Medical Insurance

SHENZHEN, China, Sept. 5, 2022 /PRNewswire/ — LifeTech Scientific Corporation (Stock Code: 1302.HK) is pleased to announce that on 30 August 2022An FDA-approved clinical trial for the company’s first-to-market LAmbre™ Plus Left Atrial Appendage (LAA) Closure System has secured medical insurance in United Statesmeaning that all patients enrolled in clinical trials will be fully covered by a USA medical insurance. This is expected to facilitate the marketing and registration of the new device United States and provide strong clinical experience to support the development of this device in the international market.

(PRNewsfoto/LifeTech)

The investigator-initiated premarket clinical trial received FDA approval in March 2022. A prospective, randomized, controlled, randomized clinical trial aimed at evaluating the safety and efficacy of LAmbre™ Plus LAA occluder implantation in patients with atrial fibrillation atrial. larger and/or less noticeable, compared to oral anticoagulants. The trial plans to enroll more than 3,000 people from 75 research centers United States and manufacture more than 1,500 installations of LAmbre™ Plus LAA occluders per fee. After meeting the established clinical goals, the company will submit the marketing of the device to the FDA.

“This is an important part of LifeTech’s global strategy. Our LAA occluders are well established United States on the basis of ‘compassionate use’, providing new treatment for patients with irreversible atrial fibrillation. Today, the first ever approval USA Researchers who have developed a pre-clinical trial and the support of medical insurance give us more confidence to advance our approach to provide this new, safe and effective method of stroke prevention to patients in the United States. States,” said Mr. Xie Yuehui, Chairman and CEO, LifeTech Scientific Corporation.

About the Lambre™ Plus LAA Closure System

The LAmbre™ Plus LAA Closure System is manufactured exclusively by LifeTech Scientific Corporation. The device closes the left atrial appendage through a percutaneous occlusion procedure to prevent stroke due to the detachment of a thrombus from the left atrial appendage. The LAmbre™ Plus LAA Closure System is an improved version of the LAmbre™ LAA Closure System, which is the most advanced medical device in the industry in terms of design and technology, and has currently been widely used in more than 40 countries with approximately 20,000 cases. in the medical profession around the world.

Concept of the company LifeTech Scientific Corporation

Founded in 1999, LifeTech Scientific Corporation (1302.HK) is dedicated to R&D, manufacturing, and sales of minimally invasive medical devices for cardiovascular and peripheral vascular disease. The company has a full range of products used in the treatment of heart disease, coronary artery disease, bradycardia, neurological, neoplastic and respiratory diseases, along with a unique iron-based bioresorbable technology. To date, 14 of the company’s products have been approved as new medical devices by the National Medical Products Administration, and with a global presence in more than 100 countries and regions, the company is currently one of the few domestic companies in China that has international presence. business structure.

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Concept of the company LifeTech Scientific Corporation