China-based Lifetech Scientific Corporation (HKG: 1302) has announced obtaining medical insurance coverage in the United States for an FDA-approved pre-clinical study of its proprietary LAmbre Plus Left Atrial Appendage (LAA) Closure System. This marks the first time a home-grown left atrial appendage closure device from China has achieved this milestone.
Clinical Trial Details
The prospective, randomized, controlled, multicenter clinical trial is designed to evaluate the safety and efficacy of the LAmbre Plus LAA occluder in reducing the risk of thromboembolism in non-valvular atrial fibrillation patients, compared to other left atrial appendage closure devices listed in the US. The trial is expected to be conducted in up to 75 study centers across the country.
Marketing Filing Outlook
Lifetech Scientific anticipates filing for marketing approval in the US after establishing the necessary clinical goals and conditions. This move represents a significant step forward for the company in expanding its presence in the US market and underscores its commitment to advancing medical innovation in the field of atrial fibrillation treatment.-Fineline Info & Tech
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