LifeTech has announced that a US Food and Drug Administration (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 USA.
This is expected to facilitate the marketing and registration process of the innovative device in the USA 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-market clinical trial received FDA approval in March 2022. This prospective, randomised, controlled, multicentre 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 enrol more than 3,000 subjects from up to 75 investigational sites in the USA and undertake more than 1,500 implantations of the LAmbre Plus LAA occluder 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 USA 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 USA,” said Xie Yuehui, chairman and CEO, LifeTech Scientific Corporation.