FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Postmarket Safety / Submissions and Approvals / Research and Development / Commercial Operations

Sealantis Trial Shows Positive Results for Seal-V Vascular Sealant

March 12, 2014
A A

Positive results from its first clinical trial of the next-generation Seal-V vascular sealant will go toward supporting a European product launch, said Haifa, Israel-based Sealantis. Seal-V mechanically seals areas where leaks may occur during surgical reconstruction of large blood vessels, including bypass surgeries and arteriovenous access for hemodialysis.

The prospective, single-arm, non-randomized postmarket trial evaluated 23 patients and 38 vascular reconstruction sites at three Israeli medical centers using different types of graft materials. In that study, the average time to hemostasis with Seal-V was just 36 seconds.

That time demonstrates that Seal-V has the potential to save time and blood in the operating room, Sealantis says. The sealant, which blends alginate pre-gel and a curing mesh, mimics the properties of algae, which allows it to bind to native blood vessels and synthetic grafts. Its lack of protein shields it from the risks of using protein-based sealants as well, Sealantis adds.

Seal-V received CE Marking last July and is currently being used in several German centers. Sealantis plans to launch the product for European vascular surgeons later this year. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.