Laminate Medical Technologies
today announced it has won FDA breakthrough device designation for its VasQ external support for patients in need of an arteriovenous fistula (AVF) for hemodialysis.
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.
The company completed enrollment of a U.S. investigational device exemption pivotal trial in February. A total of 144 current and pre-dialysis patients referred for fistula creation were included in the study for either a brachiocephalic or radiocephalic fistulas with VasQ. Follow-up for the study’s primary endpoints are expected by August 2020 and will be evaluated by the FDA through the de novo pathway, according to Laminate Medical. The patients will be followed for two years.
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.
“This is a significant milestone for VasQ that will enable a faster and smoother regulatory process for the U.S. market as well as support the necessary reimbursement for the use of the device in clinical practice to benefit patients,” said Laminate VP of clinical and regulatory affairs Orit Yarden in a news release.
“I have been anxious to get my hands back on VasQ ever since I reached the maximum enrollment for a site in the U.S. clinical study,” adde Dr. Jason Burgess of the Surgical Specialists of Charlotte, N.C. “I am excited that the FDA has recognized the urgency we have as surgeons to improve the woeful outcomes that plague fistula creation.”