WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has received U.S. Food and Drug Administration Breakthrough Device Designation for its Freesolve Resorbable Magnesium Scaffold in coronary artery procedures, potentially accelerating the regulatory review of a temporary vascular implant already sold in international markets.
The designation covers the use of Freesolve in percutaneous coronary intervention, a procedure used to treat narrowed or blocked coronary arteries. It provides access to an FDA program intended to expedite the development, assessment and review of medical devices that may offer more effective treatment for serious or life-threatening conditions.
The designation does not constitute FDA approval for commercial use in the United States. Teleflex is conducting the BIOMAG-III pivotal clinical trial to support a future premarket approval application.
Freesolve is designed to provide temporary structural support to a coronary artery following implantation, unlike conventional metallic stents that remain permanently in the vessel.
The device combines Teleflex’s BIOmag magnesium alloy with its BIOlute bioabsorbable coating technology. According to the company, 99% of the magnesium is resorbed within 12 months.
The technology could provide an alternative for patients who require temporary vessel support without a permanent implant. Teleflex also sees potential applications in procedures where drug-coated balloons may not provide sufficient structural support.
Clinical evidence cited by the company includes the BIOMAG-I first-in-human study, which reported a 3.5% target lesion failure rate at four years, with no additional clinical events recorded between the second and fourth years.
Those findings provide longer-term clinical data for the technology, while the ongoing BIOMAG-III trial is intended to generate evidence for the U.S. regulatory approval process.
“This designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention,” stated Dr. David E. Kandzari, the U.S. national principal investigator for BIOMAG-III and chief scientific officer of Piedmont Healthcare.
Freesolve already holds CE marking and is commercially available in multiple countries across Europe, Asia-Pacific, South America and the Middle East.
The new designation expands the device’s recognition under the FDA’s Breakthrough Devices Program. In 2024, the agency granted the designation to Freesolve Below-The-Knee RMS for treating chronic limb-threatening ischemia, a condition associated with severely restricted blood flow to the lower extremities.
The coronary designation creates another regulatory pathway for Teleflex as it seeks to introduce its resorbable magnesium scaffold technology to the U.S. market.
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