Oct 27 2009
Bioconnect Systems, Inc. announced today that data from the Company's first clinical study will be presented this week at the ASN Meeting in San Diego. Bioconnect’s implant platform, 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 dialysis patients.
The National Institute of Diabetes and Digestive and Kidney Diseases estimates that over 500,000 US residents undergo chronic dialysis treatment yearly. Although arteriovenous fistulae (AVFs) are the preferred form of dialysis vascular access, over 50% are unsuitable for dialysis (maturation failure) at 5 months, primarily due to peri-anastomotic stenosis.
Optiflow™ devices were implanted in ten patients requiring new arteriovenous fistulae for hemodialysis. The study was conducted under the supervision of Adrian Ebner, MD, Chief of Interventional Procedures and Cardiovascular Surgery, French Private Hospital, Asuncion, Paraguay. Additional investigators were Mark Mantell, MD (University of Pennsylvania), Roberto Manson, MD (Duke University), and Prabir Roy-Chaudhury, MD, PhD (University of Cincinnati).
The primary safety endpoint was freedom from serious adverse events at 42 days. The primary efficacy endpoint was technical success (patent AVF without complications) at the end of surgery. Secondary efficacy was defined as technical success and primary patency at 42 days.
All patients achieved technical success and 9/10 patients reached the secondary efficacy endpoint. Additionally, 9/10 patients achieved vein diameters exceeding the minimum national guideline of 6 mm needed to start hemodialysis. There were no serious adverse events related to the placement of the Optiflow™.
Dr. Ebner commented, "The Optiflow™ provides a simple method for creating a precise and repeatable anastomosis. We are encouraged by the excellent flow and vein dilation." Dr. Roy-Chaudhury added, “This data confirms the technical feasibility and safety of the Optiflow™ device. The Optiflow™ device could be an important adjunct for AVF maturation in the dialysis population, resulting in reduced costs and an improvement in patient care." Based on these favorable results, the Company is conducting a larger clinical study.
Note: The Optiflow is an investigational device and not available for commercial use in the United States.