June 7, 2020
Laminate Medical’s VasQ External Support Granted FDA Breakthrough Device Designation
June 7, 2020—Laminate Medical announced that the company’s VasQ external support for the creation of arteriovenous fistulas (AVFs) in hemodialysis patients has been granted Breakthrough Device designation from the FDA.
According to the company, the designation was based in part on clinical evidence collected so far for VasQ that consistently demonstrates improvement over the standard of care for creating functional AVFs for hemodialysis treatment. In several clinical studies, AVFs created with the VasQ external support have consistently reported success rates as high as 86% or better by 6 months.
“I have been anxious to get my hands back on VasQ ever since I reached the maximum enrollment for a site in the United States clinical study,” commented Jason Burgess, MD, in the company’s announcement. “I am excited that the FDA has recognized the urgency we have as surgeons to improve the woeful outcomes that plague fistula creation.” Dr. Burgess is with Surgical Specialists of Charlotte in Charlotte, North Carolina.
A pivotal clinical study of the VasQ is being conducted under a United States investigational device exemption; the study is expected to have completed follow-up for its primary endpoints by August 2020 and will be evaluated by the FDA through the De Novo pathway. As of February 4, 2020, the single-arm study has prospectively enrolled its entire 144 male and female patient cohort from 15 sites across the United States.
The study includes both current and predialysis patients referred for fistula creation for either brachiocephalic or radiocephalic fistulas with VasQ. The patients will be followed for 2 years with the primary efficacy endpoint of unassisted primary patency to be analyzed at 6 months. The FDA will consider the results from the study as well as the breadth of clinical evidence collected from the use of the device around the world in its decision to grant United States market clearance, advised Laminate Medical.
The company noted that the FDA Breakthrough Device program is intended to provide patients and doctors timely access to medical devices that are more effective than the current standard of care for life-threatening or irreversibly debilitating diseases or conditions. The designation is also considered by the Centers for Medicare and Medicaid Services as substantiation of clinical improvement in their consideration for providing additional reimbursement for new technologies.