FDA granted Breakthrough Device designation to the Teleflex Freesolve RMS for percutaneous coronary intervention. Teleflex announced it on October 22. The scaffold already carried a Breakthrough designation for below-the-knee use.
Freesolve is a catheter-delivered resorbable magnesium scaffold built on a BIOmag alloy with a BIOlute bioabsorbable coating. About 99 percent of the magnesium resorbs within a year. It holds a CE mark and sells across parts of Asia-Pacific, South America and the Middle East.
BIOMAG-I, the first-in-human study, reported 3.5 percent target lesion failure at four years with no new clinical events between years two and four. BIOMAG-III started enrolling in June 2026 to support a PMA. Biotronik developed the device, and Teleflex picked it up with Biotronik's vascular intervention business in 2025.
A second Breakthrough designation on the same platform buys sprint meetings and priority review on a PMA that is years out. It does not shorten BIOMAG-III.
Questions & Answers
What did FDA grant Teleflex for the Freesolve RMS?
FDA granted Breakthrough Device designation to the Teleflex Freesolve RMS for use in percutaneous coronary intervention. Teleflex announced the designation on October 22, 2026, and the scaffold already held a separate Breakthrough designation for below-the-knee applications.
What is the Teleflex Freesolve resorbable magnesium scaffold?
Freesolve RMS is a catheter-delivered coronary scaffold built on Teleflex's BIOmag magnesium alloy with a BIOlute bioabsorbable coating. About 99 percent of the magnesium resorbs within a year, and the device carries a CE mark with sales in parts of Asia-Pacific, South America and the Middle East.
What clinical data supports the Teleflex Freesolve scaffold?
The BIOMAG-I first-in-human study reported 3.5 percent target lesion failure at four years with no new clinical events between years two and four. The BIOMAG-III pivotal trial began enrolling in June 2026 to support a future PMA application.