Teleflex's Freesolve Scaffold Wins FDA Breakthrough Designation for Coronary Use

Teleflex (TFX) said the FDA granted Breakthrough Device Designation to its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention, a status that could speed review of the device. The designation, alongside the ongoing BIOMAG-III pivotal trial, could support a future U.S. Premarket Approval application, the company said. Freesolve is currently CE Marked and commercially available in parts of Europe, Asia-Pacific, South America and the Middle East. Freesolve uses Teleflex's BIOmag Magnesium Alloy and BIOlute Bioabsorbable Coating, with about 99% of the magnesium resorbed within 12 months. The BIOMAG-I First-In-Human study showed a target lesion failure rate of 3.5% at four years, with no new clinical events between years two and four. Freesolve previously received Breakthrough Device Designation in 2024 for below-the-knee use in chronic limb-threatening ischemia. TFX closed Wednesday's trading at $130.40, down 0.57%.