CardioTech Announces Initial Clinical Experience With VascuLink Vascular Access Graft.WOBURN, Mass.--(BW HealthWire)--July 21, 1997--CardioTech International Inc. (AMEX AMEX See: American Stock Exchange :CTE (Coefficient of Thermal Expansion) The difference between the way two materials expand when heat is applied. This is very critical when chips are mounted to printed circuit boards, because the silicon chip expands at a different rate than the plastic board. ) today announced Dr. Paul Bourquelot's initial clinical experience with the company's VascuLink vascular access vascular access Clinical medicine The ability to enter the vascular system; the ease with which the vascular system can be entered for administering therapy or obtaining blood for testing 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 cleanse tr.v. cleansed, cleans·ing, cleans·es To free from dirt, defilement, or guilt; purge or clean. [Middle English clensen, from Old English the blood (hemodialysis hemodialysis /he·mo·di·al·y·sis/ (-di-al´i-sis) removal of certain elements from the blood by virtue of the difference in rates of their diffusion through a semipermeable membrane while being circulated outside the body; the process ) of patients in renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, in order to compare the patency pa·ten·cy n. The state or quality of being open, expanded, or unblocked. patency the condition of being open. 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 Alan Edwards (1925—January 14, 2003) was an accomplished actor and founding Artistic Director of the Queensland Theatre Company in Brisbane, Queensland, Australia. [1] , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community 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. -0- 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 |
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