Initial Clinical Experience With VascuLink Vascular Access Graft
WOBURN, Mass.--(BW HealthWire)--July 21, 1997--CardioTech International Inc. (AMEX:CTE) today announced Dr. Paul Bourquelot's initial clinical experience with the company's VascuLink vascular access graft. Bourquelot is the organizer of the annual Vascular Access Symposium in Tours, France, a major European conference on vascular access and a leading specialist in vascular access surgery. CardioTech is currently conducting two clinical trials of its VascuLink vascular access graft in France and Holland. In these clinical trials VascuLink is used as part of a tri-weekly procedure to cleanse the blood (hemodialysis) of patients in renal failure in order to compare the patency and complication rates of VascuLink to competitors' grafts.
The experience is the result of implants conducted by Bourquelot in France.
To date, Bourquelot has implanted VascuLink in 25 percent of the patients required to complete his portion of the multi-center clinical study (five patients).
Commenting on his personal experience, Borquelot said, "The VascuLink graft can be implanted by standard surgical techniques. During the initial trials we have found three benefits: the first one is the minimal blood loss at implant; secondly, the patients can be started on dialysis via the graft much earlier than with existing materials, particularly ePTFE; and lastly, the self-sealing properties of the graft minimize blood loss at the puncture sites after the dialysis needles were withdrawn."
Alan Edwards, executive vice president and the clinical coordinator of CardioTech, stated, "This clinical experience gives a preliminary indication that, using the Vasculink vascular access graft, hemodialysis can commence early in the post-operative period, and that VascuLink is self-sealing."
Dr. Michael Szycher, chairman and CEO of CardioTech, said, "We believe that we have passed a milestone in the history of the company. If our clinical experience in France continues to be favorable, we expect the results and information gathered in the clinical trial will result in approval in the European Union via the CE marking system."
The company's clinical trials of the VascuLink in France are being conducted at three sites and will involve up to 40 patients. The clinical trial in Holland is being conducted at one site and will involve up to 20 patients. To date, VascuLink has been implanted in a total of 10 patients in these trials.
VascuLink is a trademark of CardioTech for which a registration application has been filed.
The company believes that this release may contain forward-looking statements that are subject to risks and uncertainties, including statements regarding the benefits of the VascuLink graft, the continued favorable results of CardioTech's clinical trials and regulatory approval of VascuLink. Such statements are based on management's current expectations and are subject to a number of factors that could cause actual results to differ materially from the forward-looking statements. The company cautions investors that there can be no assurance that the actual results will not differ materially from those projected or suggested in such forward-looking statements, as a result of various factors, including but not limited to the following: the company's early stage of development, uncertainties related to clinical trials, comprehensive government regulations, difficulties inherent in developing synthetic grafts, the timely development of products by the company, the company's ability to obtain financing to support its working capital needs, and intense competition related to the development of synthetic grafts. As a result, the company's further development involves a high degree of risk.
CONTACT: CardioTech International Inc.
John E. Mattern, 617/933-4772 |
