Teleflex has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Freesolve resorbable magnesium scaffold (RMS), designed for use in percutaneous coronary intervention (PCI).
The agency’s programme aims to expedite the development, assessment, and regulatory review of medical technologies that treat life-threatening or irreversibly debilitating conditions.
It is designed to provide clinicians and patients with earlier access when an unmet clinical need exists.
The Freesolve device incorporates BIOmag Magnesium Alloy and BIOlute Bioabsorbable Coating Technology to maintain vessel scaffolding during and after implantation.
Over a 12-month period, the body resorbs 99% of the magnesium. This temporary support offers clinicians an alternative to drug-coated balloons and limits the need for permanent implants.
Long-term clinical data from the BIOMAG-I First-In-Human study demonstrated a 3.5% rate of target lesion failure at four years, with no new clinical events reported between years two and four.
Teleflex is currently evaluating the device in the ongoing BIOMAG-III Pivotal Trial to support a future premarket approval application with the US regulator.
Teleflex president and interventional general manager Jason Fontana said: “At Teleflex, we are advancing vascular intervention through strategic investment and continuous innovation. This designation marks an important milestone in our efforts to bring Freesolve RMS to patients in the US.
“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.”
Freesolve holds a CE mark and is sold commercially across Asia-Pacific, Europe, the Middle East, and South America.
In 2024, the FDA granted breakthrough device designation to the Freesolve below-the-knee scaffold for chronic limb-threatening ischaemia.
