Laminate Medical Technologies said today it launched a pivotal, FDA-cleared 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.
The first procedures in the trial were recently performed by Dr. Jason Burgess and Dr. Paul Orland at Charlotte, N.C.’s Carolinas Medical Center-Mercy, Laminate said.
“We are excited to be the first site that enrolled patients in the US. The device was easy to implant and I am happy with the surgical results. We are looking forward to evaluating the device’s long term effect,” Dr. Burgess said in a press release.
“The device was easy to handle and I was very happy with the postoperative results. This new technology is targeting the major problems of AVFs: maturation and long term longevity of the fistula,” Dr. Orland said in a prepared statement.
The trial is a two-year, prospective, multi-site, 129-patient study of the device in patients who require the creation of a brachiocephalic fistula.
Study 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.
“The launch of this pivotal study marks an important step forward for VasQ in the US market and a promising milestone for patients with kidney failure. We were excited to see the high level of interest and support from our partner sites, when we offered them to participate in the study,” Laminate CEO Tammy Gilon said in a prepared release.
Last August, Laminate said it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device.
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