The U.S. Food and Drug Administration has given Laminate Medical Technologies Investigational Device Exemption (IDE) approval to begin clinical trials for its blood vessel external support device VasQ.
VasQ is an external scaffold designed to be placed over a dialysis patient’s fistula to reduce tension in the vein, allow proper blood flow during dialysis, and reduce vein blockage created by thickening of the vein wall.
The prospective, multi-center, single-arm, open-label, 13-site study will enroll 129 male and female patients, 18 to 80 years old, who require creation of new brachiocephalic fistula. The primary effectiveness endpoint for this trial will be the primary patency rate six months after creation of the arteriovenous fistula. Patients will be followed for two years.
“The current technique for creating an arteriovenous fistula is over 50 years old, but is still associated with high failure rates over time, requiring dialysis patients to undergo multiple surgical or endovascular procedures to keep their fistula functioning,” said Laminate CEO Tammy Gilon. “This is a very traumatic process for people already coping with kidney failure. We hope that this step forward will advance VasQ toward changing that process in the United States, as it already has done in Europe.