Teleflex (TFX) said Thursday that the FDA granted Breakthrough Device Designation to its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention.
The device is designed to support blood vessels temporarily, with 99% of its magnesium resorbed within 12 months, it said.
Teleflex said the scaffold recorded a 3.5% target lesion failure rate at four years in its BIOMAG-I study. An ongoing pivotal trial is intended to support a future US premarket approval application, Teleflex added.
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