FDA grants breakthrough designation to device for dialysis access
The FDA has granted breakthrough device designation to Laminate Medical’s tool for the creation of arteriovenous fistulas in patients on hemodialysis, according to a company press release.
The device, known as the VasQ External Support, is undergoing examination in a clinical study of 144 patients from 15 sites throughout the United States. The release indicated the FDA will evaluate it through the de novo pathway. Breakthrough designation was based on previous clinical evidence that has shown the device to have success rates as high as 86% by 6 months, with the release noting many AVFs have success rates of just 40%.
Of the designation, Orit Yarden, vice president of clinical and regulatory affairs for Laminate, said in the release, “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.”