Teleflex Incorporated has announced the successful completion of patient enrolment in the BIOMAG-LL clinical study, evaluating the safety and clinical performance of the Freesolve resorbable magnesium scaffold (RMS) in 35mm and 40mm lengths for the treatment of de novo coronary lesions up to 38mm.
The study reflects Teleflex’s commitment to expanding clinical evidence supporting the use of the Freesolve RMS in percutaneous coronary intervention (PCI), the company says in a press release.
BIOMAG-LL clinical study is a premarket, prospective, international, multicentre, single arm trial. The primary endpoint of the study is the target lesion failure (TLF) rate at 12 months, a composite clinical endpoint commonly used to assess the safety and effectiveness of coronary interventional devices. Clinical follow-up is conducted at one, six, 12, 36, and 60 months post-procedure.
“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” said Flavio Ribichini (University Hospital Verona, Verona, Italy). “The data generated by the BIOMAG-LL clinical study will help determine whether longer Freesolve scaffolds can expand treatment options for patients with longer lesions while supporting the broader evolution of resorbable scaffold therapy.”
The availability of longer scaffold lengths has the potential to provide physicians with additional treatment options for long lesions, reducing the need for permanent implants and potentially offering an alternative to drug-coated balloons where temporary scaffolding is required to support the vessel wall.
“We are pleased to announce the successful completion of enrolment in the BIOMAG-LL clinical study,” said Georg Nollert, vice president, medical affairs at Teleflex. “The study represents an important step in expanding the Freesolve RMS portfolio to address longer coronary lesions while maintaining the performance characteristics of our resorbable magnesium scaffold technology.”
In addition, the 35mm and 40mm Freesolve scaffold lengths are included in the ongoing BIOMAG-III pivotal clinical trial, which is currently enrolling patients in the USA and other international markets.
