LifeTech Obtains Medical Insurance Coverage for LAA Lambre Closure System Clinical Trial
LifeTech announced that a U.S. Food and Drug Administration (FDA)-cleared, investigator-initiated, pre-marketing clinical trial of its proprietary Lambre Plus Left Atrial Appendage (LAA) Closure System has obtained medical insurance coverage in the United States.
This should facilitate the process of commercializing and registering the innovative device in the United States and provide strong clinical data to support the development of the device in the global market, the company said in a press release.
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 nonvalvular atrial fibrillation and/or irregularly shaped appendages, compared to oral anticoagulants. The trial plans to enroll more than 3,000 subjects from 75 research sites in the United States and undertake more than 1,500 implantations of the LAA Lambre Plus occlusion device 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 the United States on a “compassionate use” basis, providing a novel treatment for patients with nonvalvular atrial fibrillation with irregularly shaped appendages. Today, approval of the first-ever investigator-initiated pre-marketing clinical trial in the United States and medical insurance coverage gives us greater confidence to further accelerate our process of delivering this disease prevention solution. innovative, safe and effective stroke to patients in the United States,” said Xie Yuehui, Chairman and CEO of LifeTech Scientific Corporation.