AMBLER, Pa.— Bioconnect Systems, Inc. announced that it has received CE mark approval for the Optiflow Vascular Anastomotic System.
"The Optiflow System aligns well with global initiatives to increase the rate of fistula placement and improve their function,” said Adam Dakin, Bioconnect's president and CEO. “We are encouraged by the results from our recent European clinical study."
The Optiflow is designed to increase 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 CE marking certifies that a product has met European Union health, safety, and environmental requirements, which ensure consumer safety.
The Optiflow is an investigational device and not available for commercial use in the United States.
“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 percent of these fistulae are not suitable for dialysis between four and five months after creation,” said Prabir Roy-Chaudhury, MD, PhD, Professor of Medicine in the Division of Nephrology, University of Cincinnati.” 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.”
