October 22, 2026- Teleflex Incorporated announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI).
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.