Teleflex Freesolve RMS Receives FDA Breakthrough Device Designation 

October 22, 2026—Teleflex Incorporated announced that the FDA has granted Breakthrough Device designation for its Freesolve resorbable magnesium scaffold (RMS) for percutaneous coronary intervention.

According to Teleflex, Freesolve RMS uses the company’s Biomag magnesium alloy and Biolute bioabsorbable coating technology, which provide vessel support during and after implantation; at 12 months, 99% of the magnesium is resorbed.

The Breakthrough Device designation joins the company’s ongoing BIOMAG-III pivotal trial, which is designed to support a future FDA premarket approval application, to advance Freesolve RMS toward commercialization in the United States, noted Teleflex.

David E. Kandzari, MD, serves as the United States National Principal Investigator for the BIOMAG-III trial. Dr. Kandzari is Chief, Piedmont Heart Institute, and Chief Scientific Officer, Piedmont Healthcare in Atlanta, Georgia.

“Breakthrough Device designation represents a significant milestone towards bringing Freesolve RMS technology to United States physicians and their patients,” commented Dr. Kandzari in the Teleflex press release. “This designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention.”

The company noted that the Freesolve RMS device has demonstrated positive long-term outcomes in the BIOMAG-I first-in-human study with a 3.5% target lesion failure rate at 4 years and no new clinical events between 2 and 4 years.

Teleflex stated that Freesolve RMS has received CE Mark approval and is commercially available in numerous countries across Europe, Asia-Pacific, South America, and the Middle East.

Additionally, the Freesolve below-the-knee RMS was granted Breakthrough Device designation for the treatment of chronic limb-threatening ischemia in 2024.

Teleflex acquired the Freesolve RMS devices and their clinical programs along with its acquisition of Biotronik’s Vascular Interventions business in July 2025.