TORONTO, Nov. 16 /PRNewswire-FirstCall/ - Novadaq(R) Technologies Inc. announces data published in the Journal of the American College of Cardiology (JACC) and research findings for a heart bypass drug trial in the Journal of the American Medical Association (JAMA).
Results from a prospective trial using Novadaq’s SPY(R) Intra-Operative Imaging System, published in the October 18 issue of the JACC, suggests a significant number of graft failures can be identified in the operating room. “An under appreciated number of bypass grafts have failed in the operating room and these failed grafts lead to poorer outcomes for the patient,” said Dr. Nimesh Desai of Sunnybrook and Women’s College Health Science Center in Toronto, Canada.
Research findings from the Prevent IV heart bypass drug trial were also released today in the Journal of the American Medical Association (JAMA), and presented during the American Heart Association’s Annual Scientific Sessions earlier this week. While the national study of 3,014 patients concluded the drug edifoligide was not effective in preventing bypass vein failure, researchers did identify up to thirty percent of vein grafts used in heart bypass surgery fail at one year, marking a significant increase above earlier scientific estimates of five to thirteen percent.
Heart experts acknowledge the benefits of bypass surgery for appropriately selected patients, and understand the need for further research to determine the factors of failure and durability in vein grafts. Consequences of graft failure include repeat chest pain, revascularization procedures and death. Technology to assess bypass grafts during surgery, such as the SPY System, is an important advancement in cardiac surgery.
Leading cardiac surgeons and researchers collaborated with the medical industry to develop the SPY Intra-Operative Imaging System, the first and only fluorescent imaging system available for use during heart bypass surgery. Doctors predict widespread adoption of intra-operative imaging will significantly reduce unrecognized graft failures, helping to decrease complications and repeat surgeries.
For years, heart experts have made educated estimates about the percentage of failed bypasses, because X-ray angiography, the current gold standard for assessing coronary arteries, is not considered practical for the operating room, due in part to safety risks. The result is that patient’s bypass grafts have not been routinely assessed during the operation.
Dr. Michael Mack, a cardiac surgeon and investigator in the Prevent IV trial, participated in early research and development of the SPY System. “We have been searching for a more definitive way to confirm the quality of the bypasses placed on the heart,” said Dr. Mack of Medical City Hospital in Dallas, Texas. “Now, surgeons can make necessary adjustments during a procedure, based on real-time images.”
Dr. Mercedes K.C. Dullum, cardiac surgeon at Cleveland Clinic Florida and user of the SPY System added that “This is an emerging technology that now allows us to assess our grafts intra-operatively and is a significant advancement in helping surgeons improve the quality of bypass surgery.”
In 2005 over 400,000 bypass surgeries are likely to be performed in the United States alone. The SPY System is practical for use in both traditional on-pump coronary artery bypass procedures, where the patient’s heart is stopped and blood is pumped through the body via a heart-lung machine, and off-pump coronary artery bypass procedures, where the heart is not stopped.
About Novadaq Technologies
Novadaq Technologies develops and commercializes medical devices based on its proprietary imaging platform for the diagnosis and treatment of human vascular and ophthalmic diseases and conditions. Novadaq’s SPY Intra-operative Imaging System enables surgeons to visually assess coronary vasculature and bypass graft functionality during the course of cardiac surgery. Novadaq’s ophthalmic product, the OPTTX System, is aimed at the diagnosis, evaluation and treatment of wet Age-related Macular Degeneration (AMD) by using the same core imaging technology that is used in the SPY System. The OPTTX System is currently being evaluated in clinical trials.
For more information, please visit the company’s website at www.novadaq.com.
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq’s current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings; actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Novadaq Technologies Inc.
CONTACT: Arun Menawat, PhD, MBA, President & CEO, Novadaq TechnologiesInc., Phone: (905) 629-3822 x 202, amenawat@novadaq.com; InvestorRelations: Michael Moore, The Equicom Group, Phone: (416) 815-0700 x 240,mmoore@equicomgroup.com