Printer Friendly
The Free Library
19,595,263 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

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.
COPYRIGHT 2008 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jul 10, 2008
Words:537
Previous Article:Robert L. Johnson Joins KB Home Board of Directors.
Next Article:McCormick & Schmick's Seafood Restaurants, Inc. Announces Opening in Raleigh, North Carolina.
Topics:



Related Articles
Advanced Tissue Sciences begins trials for periodontal treatment, heart tissue patch.
Aastrom Biosciences signs agreement with Mathys Medical for German bone graft clinical trial.
CARDIOTECH GRANTS BARD ACCESS WORLDWIDE RIGHTS TO CATHETERS.
Pitt researchers to conduct trial using patient's own bone marrow-derived stem cells in heart bypass surgery.
ALEXION REPORTS PHASE III RESULTS FOR PRIMO-CABG2 TRIAL.
CORNOVA GETS CE MARK FOR VALECOR CORONARY STENT SYSTEM.
Osiris receives FDA ok to initiate Phase III pivotal trial for Prochymal as first line treatment for acute GVHD.
Osiris receives FDA fast track status for Prochymal in treat Crohn's disease; European approval for treating GVHD.
Kiadis Pharma gets FDA ok to begin phase 3 trial for drug to eliminate cancer cells from autologous graft after bone marrow transplant.
Outdated FDA clinical trial policies harming transplant drug research, AST, ASTS presidents charge in letter.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles