Teleflex has successfully enrolled all the patients in the BIOMAG™-LL Clinical Study, which is investigating the performance of longer Freesolve™ Resorbable Magnesium Scaffolds in the treatment of coronary artery disease. It involves assessing the safety and efficacy of 35 mm and 40 mm scaffolds used in the treatment of de novo lesions up to 38 mm. This research helps in fulfilling the objective of Teleflex to increase the clinical data on its Freesolve™ RMS product in PCI. In addition to that, it focuses on evaluating the alternatives for treating coronary lesions in a better way.
BIOMAG™-LL is an international, multi-center, single-arm premarket study. Its main objective is to evaluate the target lesion failure (TLF) at 12 months. Follow-ups will be conduct at 1, 6, 12, 36, and 60 months after the procedure.
“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” said Prof. Flavio Ribichini, Interventional Cardiologist. “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.”
Expanding Treatment Options for Longer Coronary Lesions
PCI procedures can be complicated by long lesions in coronary vessels. Doctors have to use several instruments or overlapping implantations to make sure that all the areas are cover. But the use of longer scaffolds will help avoid using several implantations. Therefore, these devices will make the procedure simpler and will provide temporary support to the vessels. Additionally, they will serve as an alternative to drug-coated balloons.
“We are pleased to announce the successful completion of enrollment in the BIOMAG™-LL Clinical Study,” said Prof. Dr. 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.”
Conducting Additional Clinical Trials
In addition, the lengths of 35 mm and 40 mm of the Freesolve™ Scaffold are part of the BIOMAG™-III Pivotal Clinical Trial that is underway. The trial is recruiting participants from the United States and elsewhere. Results from the BIOMAG™-LL Clinical Trial may help support the application of such longer scaffolds on lesions up to 38 mm long. Moreover, such results will allow treatment of diffuse coronary artery disease.
Expansion of the Freesolve™ RMS Size Matrix
The new sizes will be added to the existing Freesolve™ RMS size matrix. Existing diameters are 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm. Existing lengths are 13 mm, 18 mm, 22 mm, 26 mm, and 30 mm. Freesolve™ RMS is currently marketed in countries accepting CE marking only.
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News Source: Businesswire.com
