Teleflex’s Freesolve Scaffold Earns FDA Breakthrough Nod for PCI

Teleflex has received a second U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Freesolve resorbable magnesium scaffold, which covers its use in percutaneous coronary intervention (PCI).

The designation recognizes the technology’s potential to address unmet clinical needs in coronary intervention. The FDA’s Breakthrough Devices Program is meant to speed development and review of technologies that could offer more effective treatment for life-threatening or irreversibly debilitating conditions.

Freesolve uses a proprietary magnesium alloy and bioabsorbable coating to support the vessel during and after implantation. Teleflex said about 99% of the magnesium is resorbed within 12 months, potentially reducing the need for a permanent implant.

The scaffold could offer physicians another option for treating narrowed coronary arteries, including cases where temporary support of the vessel wall is needed as an alternative to drug-coated balloons.

Clinical data from the BIOMAG-I first-in-human study showed a 3.5% target lesion failure rate at four years, with no new clinical events reported between years two and four, according to Teleflex.

The company is also conducting the BIOMAG-III pivotal trial to support a future U.S. premarket approval application. The study is evaluating the scaffold against a drug-eluting stent and is part of Teleflex’s effort to bring the technology to the U.S. market.

Freesolve is CE marked and commercially available in markets across Europe, Asia-Pacific, South America and the Middle East. The new designation follows an earlier FDA Breakthrough Device Designation granted in 2024 for a below-the-knee application for patients with chronic limb-threatening ischemia.

“At Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation,” said Jason Fontana, the company’s president and GM of Interventional. “This designation marks an important milestone in our efforts to bring Freesolve RMS to patients in the United States. Building on the FDA’s previous Breakthrough Device Designation for Freesolve RMS in below-the-knee applications, it further underscores the potential of bioresorbable magnesium scaffold technology and our commitment to a leave-nothing-behind approach. Freesolve RMS has the potential to redefine clinical practice in today’s cath labs.”

The company took over the Freesolve franchise after its early 2025 acquisition of Biotronik’s vascular intervention business.