Teleflex completes enrollment in longer Freesolve scaffold study

what happened

BusinessWire reported that Teleflex Incorporated has finished enrolling patients in the BIOMAG™-LL Clinical Study. The international, prospective, multicenter, single-arm premarket trial is examining the safety and clinical performance of 35 mm and 40 mm Freesolve™ Resorbable Magnesium Scaffolds in de novo coronary lesions measuring as much as 38 mm.

The primary measure is the 12-month rate of Target Lesion Failure, or TLF, a composite endpoint used for coronary intervention devices. Follow-up visits are scheduled at 1, 6, 12, 36 and 60 months after treatment. Interventional cardiologist Prof. Flavio Ribichini said the results should help assess whether longer scaffolds can broaden options for patients with diffuse coronary disease and extended lesions.

The two longer sizes are also part of the ongoing BIOMAG™-III Pivotal Clinical Trial, which is recruiting in the United States and other international markets. Freesolve™ RMS currently spans four diameters—2.5 mm, 3.0 mm, 3.5 mm and 4.0 mm—and five shorter lengths: 13 mm, 18 mm, 22 mm, 26 mm and 30 mm. The device is sold only in CE-mark accepting countries and is not approved for sale in the United States.

why it matters

Completion of enrollment begins the follow-up phase for data on longer resorbable magnesium scaffolds. The findings may inform Teleflex’s efforts to expand the technology’s clinical use, while the device remains investigational in the United States.

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