Presented summary results of four Phase 2 clinical studies in 130 patients undergoing peripheral artery bypass surgery, spinal surgery, arteriovenous graft
construction or liver resection surgery.
The double-blinded Phase 3 clinical trial evaluated the same four types of surgery examined in the Phase 2 studies: spinal surgery, liver resection, peripheral artery bypass and arteriovenous graft
In these randomized, controlled trials, 130 patients undergoing peripheral artery bypass surgery, spinal surgery, arteriovenous graft
construction or liver resection surgery had areas of intraoperative bleeding treated with gelatin sponges containing a solution of either rhThrombin or placebo.
This therapy has the advantage of being locally applied and could make a significant difference in arteriovenous graft
failure rates, a major unmet medical problem.
Its revolutionary and unique Spiral Laminar Flow (TM) technology re-establishes natural blood flow patterns in peripheral vascular and arteriovenous grafts
- helping to keep damaged blood vessels open for longer and improving outcomes for patients.
Both of these guidelines recommend that an arteriovenous fistula not be cannulated before four weeks and that arteriovenous grafts
not be cannulated before 14 days.