CardioTech Receives FDA Approval for Export of Second Graft Size for CardioPass Clinical Trial.WILMINGTON, Mass. -- 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. ), a leading developer and manufacturer of advanced biomaterials for a broad range of medical devices, today announced that it has received the necessary U.S. Food and Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") approval to export its 4mm graft in further support of the ongoing European clinical trial of CardioPass[TM] , the Company's proprietary synthetic coronary bypass coronary bypass Surgical treatment for coronary heart disease to relieve angina pectoris and prevent heart attacks. It became widely used in the 1960s. One or more blood vessels—usually an artery in the chest or a vein from the leg—are transplanted to create graft. Commenting on today's announcement, Michael Adams, 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. and President, said, "We are pleased with the FDA's timely review and approval of our request to export the 4mm graft for use in our CardioPass[TM] European clinical trial. This important milestone provides a second graft size available for use in the trial and expands the potential patient population available for treatment. In concert with our team of clinical and regulatory professionals in Europe, we believe we are now poised to move towards the completion of our clinical trial." Approval by the Notified Body for a CE Mark would allow CardioPass[TM] to be marketed and sold in all 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 countries as well as other countries worldwide that accept this approval for registration within those countries. CardioPass[TM] Synthetic Graft for Coronary Artery Bypass Coronary artery bypass Surgical procedure to reroute blood around a blocked coronary artery. Mentioned in: Heart Failure coronary artery bypass, n : CardioPass[TM] is designed to be an effective alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20 percent of all bypass procedures. CardioPass[TM] is made from ChronoFlex[R], the Company's proprietary biodurable medical-grade polymer and engineered to be pulsatile pulsatile /pul·sa·tile/ (pul´sah-til) characterized by a rhythmic pulsation. pul·sa·tile adj. Undergoing pulsation. pulsatile characterized by a rhythmic pulsation. , biostable, torque-resistant and suturable. Once it is implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex[R] has also been specially formulated to be flexible, enabling CardioPass[TM] to pulse like a human vein would as it carries blood to the heart. About CardioTech International: Through its newly formed AdvanSource Biomaterials Corporation subsidiary, CardioTech develops advanced polymer materials which provide critical characteristics in the design and development of medical devices. The Company's biomaterials are used in devices that are designed for treating a broad range of anatomical sites and disease states. The Company's business model leverages its proprietary materials science technology and manufacturing expertise in order to expand its product sales and royalty and license fee income. CardioTech is conducting a clinical trial for regulatory approval in Europe for its CardioPass[TM] synthetic coronary bypass graft. More information about CardioTech is available at its new website: www.advbiomaterials.com Forward-Looking Statements: CardioTech believes that this press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Such forward-looking statements are subject to risks and uncertainties. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause results to differ materially from the forward-looking statements. For further information on such risks and uncertainties, you are encouraged to review CardioTech's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended March 31, 2008. CardioTech assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law. |
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