CardioTech Announces Third CardioPass Patient and Start of Phase II Brazilian Clinical Trials
CardioTech International, Inc. (Amex: CTE, news) today announced that on October 13 a 76 year old hypertensive female was implanted with the CardioPass coronary artery bypass graft at the Institute for Cardiology, Porto Alegre, Brazil. Catheterization on the 15th post-operative day showed evidence of open and functioning coronary arteries, with the patient is doing well.
According to protocol, the triple bypass was performed using the CardioPass to bypass the circumflex artery; the left internal mammary artery was used to bypass the left anterior descending, and a radial artery was used to bypass a diagonal artery.
CardioTech is one of only two companies in the world in clinical trials with a synthetic coronary artery bypass graft. This technology addresses a potential market of $1.5 billion annually.
Michael Szycher, CEO of CardioTech international stated: “With this third implantation, we are freezing the “Nesralla” protocol and entering Phase II. Phase II trials will involve an additional 10 clinical centers in Brazil and Chile. In order to fully comply with FDA, European and Brazilian regulations, as we enter Phase II of our clinical study per current clinical trial methodology we will not report on individual patients but will report when patient enrollment and analysis is complete.”
During CABG surgery, a surgeon takes a segment of a healthy vein or artery from another part of the body and uses it to create a detour or bypass around the blocked portion of the diseased coronary artery. A patient may undergo one, two, three or more bypasses, depending upon how many coronary arteries are blocked.
CardioTech International, Inc., headquartered in Woburn, Massachusetts, uses its proprietary manufacturing technology to develop and manufacture vascular grafts, or synthetic blood vessels, made of ChronoFlex, a family of polyurethanes that has been demonstrated to be biodurable and biocompatible.
