Teleflex Receives FDA Breakthrough Device Designation For Its Freesolve Resorbable Magnesium Scaffold For Percutaneous Coronary Intervention

To qualify for a BDD, device technology must address an unmet clinical need and show that it has the potential to provide for more effective treatment of life-threatening diseases or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and clinicians with timely access to these breakthrough treatments by accelerating their development, assessment and review.

Freesolve™ RMS utilizes the proprietary BIOmag™ Magnesium Alloy and BIOlute™ Bioabsorbable Coating Technology, providing vessel support during and after implantation.1,2 At 12 months, 99% of the magnesium is resorbed.3

Freesolve™ RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons in cases where temporary scaffolding is required to support the vessel wall. Freesolve™ RMS has already shown positive long-term outcomes in the BIOMAG™-I First-In-Human (FIH) Study (NCT04157153), demonstrating a 3.5% target lesion failure (TLF)* rate at four years and no new clinical events between two and four years.4