Laminate Medical Technologies said this week it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis.
The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure.
The device regulates flow by constraining and shaping the fistula and reinforces and shields the perianastomotic vein against high pressure, wall tension and flow levels, the company said.
Laminate Medical plans to initiate a prospective, 13-site, 129-patient study of the device in patients who require the creation of a brachiocephalic fistula. Researchers will assess additional eligibility criteria in the trial, including adequate blood vessel anatomy and possible past and current medical conditions and co-morbidities that would preclude participation, the company said.
Primary effectiveness endpoints for the trial will be primary patency rates at 6 months post-creation of the fistula, with patients followed up to 2 years, Laminate Medical said.
“IDE approval for this pivotal study marks an important step forward for VasQ in the American market and a promising milestone for patients with kidney failure. 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. 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,” CEO Tammy Gilon said in a press release.
In February, Laminate Medical said it raised $8 million in a Series B financing round to support its VasQ blood vessel support device.