Teleflex Manta Vascular Closure Device Approved in Canada

May 18, 2022—Teleflex Incorporated announced that it received Health Canada approval for the Manta vascular closure device, which is designed specifically for large-bore femoral arterial access site closure. The Manta device is available in Canada in 14- and 18-F sizes.

According to the company, the Manta device is indicated for closure of femoral arterial access sites while reducing time to hemostasis after the use of 10- to 20-F devices or sheaths (12- to 25-F outer diameter) in endovascular catheterization procedures.

Approval was supported by the SAFE MANTA investigational device exemption clinical trial that was conducted in Canada and the United States. It was a prospective, multicenter, single-arm trial of purpose-designed, large-bore femoral access site closure. SAFE MANTA demonstrated that the Manta device successfully achieved fast, reliable biomechanical closure with rapid hemostasis, with all primary and secondary endpoints met, stated the company.

“In a selected population of patients, this study demonstrated that the Manta vascular closure device can safely and effectively close large-bore arteriotomies created by current-generation transcatheter aortic valve replacement, percutaneous endovascular aneurysm repair, and thoracic endovascular aortic repair devices,” concluded David A. Wood, MD, in the Teleflex press release. Dr. Wood is Coprincipal Investigator of SAFE MANTA and Director of the University of British Columbia Center for Cardiovascular Innovation in Vancouver, Canada.