Bioconnect's Optiflow Vascular Anastomotic System granted CE mark approval

Bioconnect Systems, Inc. today announced CE mark approval for the Optiflow™ Vascular Anastomotic System. The Optiflow™ enhances a surgeon's ability to create precise vascular connections. The initial indication is the creation of an arteriovenous fistula needed for vascular access in hemodialysis patients.

“The Optiflow System aligns well with global initiatives to increase the rate of fistula placement and improve their function. We are encouraged by the results from our recent European clinical study.”

Prabir Roy-Chaudhury, MD, PhD, Professor of Medicine in the Division of Nephrology, University of Cincinnati, commented, "The creation and maintenance of vascular access in dialysis patients remains a major clinical challenge. While initiatives such as Fistula First are increasing the rate of fistula placement, studies have shown that up to 60% of these fistulae are not suitable for dialysis between four and five months after creation. Thus, there is a huge unmet clinical need for therapies which can improve fistula function and maturation. Early clinical experience suggests the Optiflow may improve patient outcomes for dialysis access."

Adam Dakin, Bioconnect's President & CEO, added, "The Optiflow System aligns well with global initiatives to increase the rate of fistula placement and improve their function. We are encouraged by the results from our recent European clinical study."