Teleflex, a Wayne, Pennsylvania-based medical technology company, has received a U.S. Food and Drug Administration (FDA) designation meant to speed the review of its dissolving heart scaffold, the company announced on October 22, 2026. The FDA granted Breakthrough Device Designation (BDD) to the Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI), a minimally invasive procedure that opens narrowed heart arteries. Freesolve™ RMS is investigational in the U.S.
“Breakthrough Device Designation represents a significant milestone towards bringing Freesolve™ RMS technology to U.S. physicians and their patients,” said Dr. David E. Kandzari, U.S. National Principal Investigator for the BIOMAG™-III Pivotal Trial, Chief of Piedmont Heart Institute, and Chief Scientific Officer of Piedmont Healthcare in Atlanta. “This designation recognizes the potential of resorbable scaffolds to address an important unmet clinical need in contemporary coronary intervention.”
What the Designation Means
The FDA’s breakthrough program is designed to speed the development, assessment, and review of devices for life-threatening or irreversibly debilitating conditions. To qualify, a device must address an unmet clinical need and show potential to provide more effective treatment. The designation is not an approval.
This is the second BDD for the Freesolve platform. In 2024, the FDA granted the designation to Freesolve™ Below-The-Knee (BTK) RMS for chronic limb-threatening ischemia (CLTI), a severe blockage of arteries in the legs. Freesolve™ BTK RMS is also not approved for sale in the U.S.
“This designation marks an important milestone in our efforts to bring Freesolve™ RMS to patients in the United States,” said Jason Fontana, President and General Manager of Interventional at Teleflex. “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.”
How the Scaffold Works
Freesolve™ RMS, known clinically as DREAMS 3G RMS, is built from Teleflex’s BIOmag™ Magnesium Alloy and coated with its BIOlute™ Bioabsorbable Coating. It supports the artery wall during and after the procedure, then dissolves over time. According to Teleflex, 99% of the magnesium is absorbed by the body within 12 months.
Teleflex says the scaffold could give physicians another option that reduces the need for permanent implants. It could also serve as an alternative to drug-coated balloons when the vessel wall needs temporary support.
In the BIOMAG™-I first-in-human study (NCT04157153), the target lesion failure (TLF) rate at four years was 3.5%, with no new clinical events between years two and four, according to Teleflex. TLF combines heart attack in the treated vessel, repeat procedures on the treated area, and cardiac death.
The Path to U.S. Approval
Teleflex is running the BIOMAG™-III Pivotal Trial (NCT07258290) to support a future Premarket Approval (PMA) application with the FDA. Together with the new designation, the company says the trial may support eventual U.S. availability.
Freesolve™ RMS already carries the CE Mark and is sold in countries across Europe, the Asia-Pacific region, South America, and the Middle East.
About Teleflex
Teleflex is a global medical technology company with products in anesthesia, emergency medicine, interventional cardiology and radiology, interventional urology, surgery, urology, vascular access, and military and federal health. Its brands include Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™, and Weck™. In 2025, Teleflex completed its acquisition of BIOTRONIK’s vascular intervention business.
