WAYNE, PA — Teleflex Inc. (NYSE: TFX) has begun enrolling patients in a global pivotal study of its Freesolve resorbable magnesium scaffold, advancing the company’s effort to bring a temporary alternative to permanent coronary stents to market.
The BIOMAG-III trial will enroll 1,859 patients at up to 120 sites worldwide, including as many as 60 in the United States, and compare the performance of the Freesolve Resorbable Magnesium Scaffold (RMS) against Abbott’s Xience drug-eluting stent, the company said.
The study is designed to support future regulatory submissions and represents the largest planned clinical evaluation of the device to date.
The trial comes as Teleflex also completed enrollment ahead of schedule in the BIOMAG-II study, which enrolled 1,861 patients across 20 countries in Europe and the Asia-Pacific region. That trial is also comparing Freesolve against the Xience stent, with both studies measuring target lesion failure rates at 12 months.
Resorbable scaffolds have long been viewed as a potential next step in coronary intervention because they are designed to provide temporary support to narrowed arteries and then dissolve, potentially avoiding long-term complications associated with permanent metallic implants.
“I’m proud that the very first patient in the BIOMAG-III IDE trial has been enrolled at MedStar Health,” said Dr. Ron Waksman, chairman of the study’s steering committee and associate director of cardiology at MedStar Washington Hospital Center. He described the trial as a step toward potentially changing the treatment of narrowed arteries, a common cardiovascular condition.
The first U.S. implantation in the investigational device exemption trial was performed by Dr. Itsik Ben-Dor of MedStar Health in Washington, D.C.
Teleflex also recently reported four-year data from its earlier BIOMAG-I first-in-human study, which showed a 3.5% target lesion failure rate and no new clinical events between the second and fourth years following implantation.
“The BIOMAG-III Study represents an important milestone in the evolution of resorbable technologies,” said Dr. David Kandzari, the U.S. national principal investigator for the trial and chief scientific officer of Piedmont Healthcare. He noted that Freesolve has shown a plateauing of clinical events after the scaffold is absorbed, a long-standing objective of resorbable scaffold development.
Freesolve is engineered to resorb within 12 months, according to Teleflex, and the company said the new trial is intended to generate the clinical evidence needed to bring the technology to broader clinical use.
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