Massachusetts-based CardioTech International Inc. announced that it will make a presentation at the 32nd Congress of the Brazilian Society for Cardiovascular Surgery on April 29, 2005 in Vitoria, Brazil, on its synthetic coronary bypass graft.
The presentation will include an update on the three Brazilian “no-option” patients who participated in the Phase I human clinical trials, an overview of the proposed clinical protocol for conducting Phase II trials, and a discussion of the technology utilized in the manufacture of the CardioPass synthetic coronary artery bypass graft.
After one and one half years post-implantation, all three patients are leading normal lives and are asymptomatic, a remarkable clinical achievement.
Presenting will be Dr. Michael Szycher, the company’s Chief Executive Officer and founder, who previously was a member of the Thermedics team that developed the HeartMate, a left ventricular assist device (LVAD), and who also founded PolyMedica Corporation.
Thermedics and PolyMedica are manufacturers of innovative cardiovascular medical devices. The presentation will be entitled: “A Report from the Inventor of the CardioPass Synthetic Coronary Artery Bypass Graft”.
Joining Dr. Szycher in the presentation will be Professor Ivo Nesralla and Dr. Guaracy Texeira, who will be distributing and discussing the clinical protocol to the international audience of heart surgeons.
Professor Ivo Nesralla is the Chairman of Cardiac Surgery and President of the Instituto de Cardiologia do Rio Grande do Sul of Porto Alegre, Brazil.
Dr. Nesralla is one of the pioneering surgeons who successfully completed the first HeartMate LVAD surgery in Brazil. Dr. Texeira is a senior cardiovascular surgeon on the staff of the Institute who developed the protocol that will be used in Brazil.
CardioTech’s current plans are to enroll a total of 30 patients, who will be followed 6 months angiographically, plus an additional 6 months clinical assessment, for a total of 12 months post-operatively. They expect to receive Brazilian Phase II approval by mid 2005.
The CardioPass synthetic coronary artery bypass graft was designed to mimic the human saphenous veins in biomechanical properties. Any surgeon should be able to implant these grafts without any additional training since the surgical implantation protocol is identical to current procedures that have been in use for decades throughout the world.
The trials will be conducted on “no option” patients who, having had failed previous bypass operations, are now in need of a “re-do” procedure.
CardioTech International Inc.