Laminate Medical Technologies announced that it completed enrollment into its VasQ external support U.S. pivotal study of patients in need of an arteriovenous fistula (AVF) for hemodialysis.
The study prospectively enrolled 144 male and female patients, both brachiocephalic and radiocephalic AVF patients, across 17 sites in the U.S. They are slated to be followed for two years with a primary endpoint of primary patency analyzed at six months.
Tel Aviv, Israel–based Laminate’s VasQ device is a nitinol external support placed around the artery and vein at the creation site. It is designed to optimize the transition of arterial flow to the vein while it reinforces the vessel wall against an increase in mechanical stress.
According to a news release, VasQ patients in Europe have demonstrated increased rates of receiving a usable AVF with fewer earlier failures and additional procedures in data that the company plans to validate with its U.S. study. The study launched in January 2018, while the company pulled in a $12 million funding round for the device in January 2019.
“We are grateful to our principle investigators for their commitment to this study,” Laminate CEO Tammy Gilon said in the news release. “The results will be an important addition to the mounting evidence supporting the benefits of VasQ to promote the usability of both forearm and upper arm fistulas.”
Duke University professor of surgery Dr. Ellen Dillavou added that she believes the VasQ device offers the strongest probability of success and could become the new standard of care.
“The device has performed as expected in my study patients so far, and I look forward to continue to utilize it once commercially available in the U.S.,” Dillavou said.