“Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons in cases where temporary scaffolding is required to support the vessel wall,” the device developer said in a news release.
The catheter-delivered device already has a CE mark and is also available in Asian-Pacific, South American and Middle Eastern countries. The FDA’s Breakthrough Device program accelerates product development and review for devices with potential to more effectively treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.
October 2026: Former Medtronic RDN leader Jason Fontana joins Teleflex
Freesolve RMS uses the proprietary BIOmag magnesium alloy and BIOlute bioabsorbable coating technology to provide vessel support during and after implantation, with 99% of the magnesium absorbed into the patient’s body after a year to keep options available for future therapies.
Teleflex said Freesolve RMS demonstrated a 3.5% target lesion failure (TLF) rate at four years and no new clinical events between two and four years in the BIOMAG-I first-in-human study.
The device was developed by Biotronik and sold with the rest of the company’s Vascular Intervention Business to Teleflex in 2025.
Teleflex is the world’s 55th largest medical device company according to Medical Design & Outsourcing‘s 2026 Medtech Big 100 ranking by revenue.
