Teleflex begins global BIOMAG-III trial for Freesolve scaffold

Teleflex Incorporated has begun enrollment in the global BIOMAG-III Study, a landmark clinical trial evaluating the Freesolve Resorbable Magnesium Scaffold (RMS). The study aims to generate pivotal evidence required to support future regulatory applications for the technology, which is designed to resorb within 12 months and potentially reduce long-term events associated with permanent metallic implants. The trial represents the most comprehensive planned clinical evaluation of Freesolve RMS to date.

Trial Design and Scope

The BIOMAG-III Study is a randomized controlled trial (RCT) designed to compare Freesolve RMS to Xience Drug-Eluting Stent (DES) with respect to Target Lesion Failure (TLF) rate at 12 months. The study plans to enroll 1,859 patients across up to 120 sites worldwide, including up to 60 sites in the United States. The trial will include scaffold lengths up to 40mm.

Study Parameter	Details
Study Type	Randomized Controlled Trial (RCT)
Planned Enrollment	1,859 patients
Comparator	Xience Drug-Eluting Stent (DES)
Primary Endpoint	Target Lesion Failure (TLF) rate at 12 months
Global Sites	Up to 120 sites
U.S. Sites	Up to 60 sites
Scaffold Lengths	Up to 40mm

Clinical Milestones and Data

The initiation of the BIOMAG-III Study follows the recent completion of enrollment in the BIOMAG-II Study, which finished ahead of schedule. That study enrolled 1,861 patients across 20 countries in Europe and Asia Pacific and is also a prospective, international, multi-center RCT comparing Freesolve RMS with Xience DES regarding TLF rate at 12 months.

Additionally, Teleflex recently reported positive long-term data from the BIOMAG-I First-In-Human (FIH) Study. The results demonstrated a 3.5% TLF at four years and showed no new clinical events between the two-year and four-year marks for Freesolve RMS.

Expert Perspectives

Dr. Ron Waksman, Associate Director of Cardiology at MedStar Washington Hospital Center and Chairman of the steering committee for the BIOMAG-III Study, emphasized the importance of the research. "Contributing to this important international study is the first step towards potentially changing how we treat narrowed arteries," he stated. Dr. Itsik Ben-Dor of MedStar Health in Washington, D.C., became the first implanter in the United States for the IDE trial.

Dr. David E. Kandzari, U.S. National Principal Investigator for the BIOMAG-III Study and Chief Scientific Officer at Piedmont Healthcare, noted the technology's potential. "Freesolve RMS technology has shown positive outcomes in the BIOMAG-I FIH trial, with a plateauing of clinical events after resorption," he said.

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.