The clinical trial was conducted using the Ventrica Magnetic Vascular Positioner (MVP), a revolutionary and proprietary method for creating a sutureless vessel anastomosis, using magnetic attraction to form an instantaneous self-aligning, self-sealing connection between two blood vessels. The trial was designed to evaluate the safety and performance of the MVP System.
Volkmar Falk, M.D., Ph.D. presented the data on behalf of Uwe Klima, M.D., Ph.D. and Gerhard Wimmer-Greinecker, M.D., Ph.D. to an international audience of over 700 attendees. Interim results of the clinical trial, which included thirty-two patients, showed a pre-discharge angiographic patency rate of 94 percent. The trial also demonstrated a 100 percent pre-discharge angiographic patency in the Left Internal Mammary Artery to the Left Anterior Descending coronary artery (LIMA to LAD) subset.
The Ventrica MVP Study represents the first reported multi-centre experience with an anastomotic device, which connects the "bypass graft" to the coronary artery, and is called distal connection. "This technology has the potential to facilitate beating heart procedures in minimally invasive coronary bypass surgery by creating a high quality, reproducible, and rapid anastomosis", remarked Dr. Falk.
"We are very excited to report these landmark results", stated Mark Foley, Ventrica's president and CEO. "Never before has a mechanical device been successfully used to attach both arterial and venous bypass grafts to all major vessels of the heart." The trial is being conducted at three leading heart centres in Europe, including the Johann Wolfgang Goethe University Hospital in Frankfurt, the Heart Center in Leipzig, and the Medical Hospital in Hannover. Ventrica has recently received approval to expand the MVP clinical investigation to Canadian institutions.
Coronary artery disease is a major health care problem worldwide and is the leading cause of death in the United States. Approximately 700.000 bypass procedures are performed each year. The current methods of coronary bypass surgery can be time consuming, technically demanding, and have limited the ability for minimally invasive CABG surgery to be routinely performed due to the constraints of manually suturing these blood vessels together.
The Ventrica MVP System may reduce many of the challenges which are currently limiting minimally invasive bypass surgery such as space constraints, lengthy procedure times, and ease of use. In addition, this technology may have the ability to potentially expand the number of beating heart CABG procedures, "closed chest", and robotic CABG procedures. "With our patented and revolutionary technology, we are hoping to further advance the field of less invasive CABG surgery", commented Mark Foley.
In July 2001, David H. Adams, M.D., newly appointed chairman of the department of cardiothoracic surgery at Mount Sinai Medical Center in New York, presented the pre-clinical results, on behalf of his group and a team at the University of British Columbia headed by Sam Lichtenstein, M.D. Ph.D., and Ji Zhang, M.D., at the International Society for Minimally Invasive Cardiac Surgery (ISMICS).
This abstract was chosen among 250 submissions to receive the President's Award for what was called the "Best in innovative surgical science with practical application and contribution for the future of Cardiac Surgery". Dr. Adams commented that "these clinical data presented by Dr. Falk support our earlier findings regarding the performance, simplicity, and repeatability of this breakthrough technology".
Ventrica Inc. was founded in 1998 to develop technologies, which would enable less-invasive coronary bypass surgery. The aim of the company was to combine the minimally invasive aspects of interventional cardiology in the treatment of heart disease with the long-term success of coronary artery bypass surgery. The pursuit of this goal has yielded what the company believes to be breakthrough technology for automating the anastomotic connection of blood vessels.