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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on October 27, 2009, 10:04:38 PM
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Bioconnect Systems to Present First in Man Results for Optiflow Vascular Implant
Tue Oct 27, 2009 7:48am EDT
Data to be presented at American Society of Nephrology by Prabir Roy-Chaudhury,
MD, PhD
AMBLER, Pa.--(Business Wire)--
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.
Bioconnect Systems, Inc.
Adam Dakin, CEO
215-646-6830
adakin@bioconnectsystems.com
http://www.reuters.com/article/pressRelease/idUS125939+27-Oct-2009+BW20091027