Teleflex Receives FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold

Teleflex Incorporated has received Breakthrough Device Designation from the FDA for its Freesolve™ Resorbable Magnesium Scaffold, aimed at improving percutaneous coronary intervention procedures. This designation is expected to expedite the development and review process for the device, which is currently undergoing evaluation in the BIOMAG™-III Pivotal Trial. Although the Freesolve™ RMS is CE Marked and available in international markets, it is not yet approved for sale in the U.S.