Dialysis company Laminate Medical Technologies reported on Thursday the start of its US FDA pivotal study of VasQ in patients suffering from kidney failure and in need of dialysis that requires vascular access in the US.
The company added that the first surgeries were performed by Dr Jason Burgess and Dr Paul Orland at the Carolinas Medical Center-Mercy, Charlotte, North Carolina.
This prospective, multi-centre, 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. During screening, surgeons will assess additional eligibility criteria such as adequate blood vessel anatomy and absence of potentially precluding past and current medical conditions and comorbidities, stated the company.
According to the company, VasQ is an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis. VasQ is an external scaffold placed over the fistula, creating an optimal geometric configuration with the artery and reducing the tension in the vein. This allows proper blood flow during dialysis, while reducing vein blockage created by thickening of the vein wall.
In conjunction, the primary effectiveness endpoint for this VasQ trial will be the primary patency rate six months after creation of the arteriovenous fistula. Patients will be followed for a total of two years, concluded the company.
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