Sealantis has reported successful results from its first non-randomized clinical study that tested the safety and performance of Seal-V, a vascular sealant that helps rapidly control bleeding during vascular surgery.
The prospective, single-arm study was conducted at three medical centers in Israel. The study, which involved 23 patients and 38 vascular reconstruction sites using various types of graft materials, met all primary and secondary end-points.
The study results demonstrated that the average time to hemostasis (bleeding cessation) using Seal-V was approximately 36 seconds. During the three-month follow-up period, no device related complications or adverse events were reported. Sealantis will use the study results to advance the launch of Seal-V in Europe by later 2014.
Seal-V, which represents a new generation in tissue sealing technology, works by mechanically sealing areas of potential leakage during surgical reconstruction of large blood vessels including bypass procedures and arterio-venous access for hemodialysis.
The product imitates the properties of algae, giving it an inherent ability to strongly bind to both native blood vessels and synthetic grafts, even in wet and moist conditions. Additionally, the protein-free composition relieves Seal-V from risks associated with the use of protein-based sealants.
Sealantis CEO Tomer Fuchs noted Seal-V performed extremely well in the clinical study and consistently demonstrates exceptional performance in current clinical use.
"We have received positive feedback and increasing interest from surgeons and from the market. Our intention is to make Seal-V available to vascular surgeons in Europe later this year," Fuchs added.
Sealantis obtained CE Mark approval for Seal-V in July 2013 and the product is currently being used in several clinical centers in Germany, towards the coming product launch.