Laminate Medical Technologies, an Israeli firm, won an Investigational Device Exemption (IDE) from the FDA to begin a clinical trial of its VasQ device designed to support arteriovenous fistulas. The technology will hopefully benefit patients that receive hemodialysis via AVF in the upper extremity.
In many dialysis patients the fistulas that are created too often have trouble staying in shape and may require revision procedures. Additionally, the connection may narrow, leading to complications, and blood turbulence near the connection can lead to clots or cell lysis.
The VasQ device, made of Nitinol memory alloy, supports a fistula by wrapping around a vein and holding the artery so it doesn’t disconnect. The connection, being more secure and retaining its shape, prevents blockages, disconnections, and reduces the turbulence of blood as it moves through the fistula.
Here’s a bit of detail about the study approved by the FDA that will test the VasQ for safety and efficacy:
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. 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. The primary effectiveness endpoint for this trial will be the primary patency rate 6 months after creation of the arteriovenous fistula. Patients will be followed for a total of 2 years.
Here’s an informative video from Laminate Medical Technologies explaining the workings of the VasQ device:
Product page: VasQ…
Via: Laminate Medical…