WAYNE, PA — Teleflex Incorporated (NYSE: TFX) reported four-year follow-up results from a first-in-human clinical study of its Freesolve resorbable magnesium coronary scaffold, providing long-term safety data as the company advances efforts to compete in the market for next-generation cardiovascular implants.
The results, presented at the EuroPCR conference in Paris, followed 116 patients enrolled across European centers in the BIOMAG-I clinical trial. Teleflex reported that no cardiac deaths, target-vessel heart attacks, or confirmed scaffold thrombosis events were observed through four years of follow-up.
The study evaluated the company’s third-generation Freesolve Resorbable Magnesium Scaffold, a device designed to provide temporary support to coronary arteries before gradually dissolving. The technology is intended to address concerns associated with permanent metallic stents while maintaining vessel support during healing.
According to data presented by Prof. Jan Torzewski of Klinikverbund Allgäu in Germany, the study recorded a target lesion failure rate of 3.5% through four years. The company reported that those events were driven by clinically driven target lesion revascularization procedures, with only one occurring after the scaffold’s one-year resorption period.
“The absence of cardiac death, target-vessel MI, or scaffold thrombosis throughout four years, combined with the very low TLF rate, is highly promising and aligns with the vascular healing response we aim to achieve with bioresorbable technologies,” noted Prof. Michael Haude, principal investigator of the BIOMAG-I study.
The findings are notable because bioresorbable scaffold technologies have faced scrutiny over the past decade as manufacturers sought to demonstrate long-term safety and effectiveness compared with conventional drug-eluting stents, which remain the standard treatment for many coronary artery disease patients.
Teleflex indicated that the four-year results will support ongoing BIOMAG-II and planned BIOMAG-III randomized controlled trials, which are intended to determine whether the device can serve as an alternative to contemporary drug-eluting stents.
“Our focus is on enabling durable clinical outcomes, so we’re delighted to see this plateau of events continuing out to 4 years,” stated Georg Nollert, Teleflex’s vice president of medical affairs. “This gives us even more confidence that RMS could be a valuable option for treating patients where the aim is to avoid a permanent implant.”
Freesolve is manufactured using Teleflex’s proprietary BIOmag magnesium alloy and is designed to fully resorb within approximately 12 months after implantation.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.