FDA grants breakthrough device status to Teleflex’s coronary scaffold

Teleflex (TFX) received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold, a device for percutaneous coronary intervention. The scaffold, using proprietary magnesium alloy, is resorbed within 12 months, reducing the need for permanent implants. The company reported a 3.5% target lesion failure rate at four years in clinical trials. The designation may support a future U.S. Premarket Approval application. TFX closed at $130.40, down 0.57%.

Teleflex (NYSE:TFX) received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold, which showed a 3.5% target lesion failure rate at four years in a study. The device is under investigation in the U.S. but is available in other regions. The designation aims to expedite development and review of the device.

Teleflex Inc. (TFX) received FDA Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold, aiding accelerated development and review. The designation supports the ongoing BIOMAG-III pivotal trial for a future PMA, potentially boosting U.S. revenue.

Teleflex's Freesolve™ RMS, a magnesium-based artery support device, received FDA Breakthrough Device Designation. The device is designed to be absorbed by the body within a year, potentially reducing the need for permanent implants. According to Teleflex, it showed positive long-term outcomes in the BIOMAG™-I study and is currently in the BIOMAG™-III Pivotal Trial. The device is not yet approved in the U.S. but is commercially available in CE-mark accepting countries.

Teleflex (NYSE:TFX) completed enrollment in its BIOMAG-LL study, evaluating longer Freesolve Resorbable Magnesium Scaffolds for coronary lesions. The trial enrolled 102 patients across Europe, with primary endpoint being Target Lesion Failure rate at 12 months. The study is part of expanding the Freesolve RMS portfolio, according to the company.

Teleflex Inc. completed enrollment of 102 patients in the BIOMAG™-LL Clinical Study across 14 European centers to evaluate 35 mm and 40 mm Freesolve™ Resorbable Magnesium Scaffolds for long coronary lesions. The study aims to assess safety and effectiveness, with primary endpoint Target Lesion Failure (TLF) rate at 12 months. The data could expand treatment options for diffuse coronary artery disease, supporting the broader use of resorbable scaffold technology.