Teleflex presents 4-yr follow-up data from BIOMAG-I study
Teleflex Incorporated reported four-year data from the BIOMAG-I study showing a 3.5% target lesion failure rate for its Freesolve Resorbable Magnesium Scaffold, with no cardiac deaths or scaffold thrombosis observed through the period.

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Teleflex Incorporated announced four-year follow-up data from the First-in-Human BIOMAG-I Clinical Study, confirming the long-term safety and sustained performance of its Freesolve Resorbable Magnesium Scaffold (RMS). Presented at the EuroPCR conference in Paris, France, the study demonstrated a persistently low target lesion failure (TLF) rate of 3.5% with no new cardiac-related events observed between the two and four-year follow-up periods.
The study enrolled 116 patients exclusively across European centers. Through four years, there were no reports of cardiac death, target-vessel myocardial infarction (TV-MI), or definite or probable scaffold thrombosis. The TLF rate was driven by clinically-driven target lesion revascularization (CD-TLR), with only one event occurring beyond the scaffold's 12-month resorption period.
Clinical Outcomes and Safety Profile
The data reinforces the safety profile and sustained device performance of the Freesolve RMS. Prof. Michael Haude, Principal Investigator of the BIOMAG-I Study, highlighted the absence of major adverse cardiac events as a promising indicator of vascular healing response associated with bioresorbable technologies.
| Metric | Four-Year Result |
|---|---|
| Target Lesion Failure (TLF) | 3.5% |
| Cardiac Death | 0% |
| Target-Vessel Myocardial Infarction (TV-MI) | 0% |
| Definite or Probable Scaffold Thrombosis | 0% |
Future Clinical Trials
The favorable four-year outcomes provide a foundation for the ongoing BIOMAG-II and pending BIOMAG-III Randomized Controlled Trials. Prof. Dr. Georg Nollert, Vice President Medical Affairs at Teleflex, noted that the plateau of events continuing to four years supports the potential of RMS as a valuable option for patients seeking to avoid permanent implants.
The Freesolve RMS is made of the proprietary BIOmag Magnesium Alloy and maintains a resorption time of 12 months. It is commercially available in CE-mark accepting countries and is an investigational device limited by United States law to investigational use.
What are the primary endpoints and expected timelines for the ongoing BIOMAG-II and pending BIOMAG-III trials?
How will the positive four-year data influence Teleflex's regulatory strategy for FDA approval in the United States?
What market share can Freesolve RMS realistically capture in the CE-mark countries against established permanent drug-eluting stents?

























