SPY fluorescence imaging system receives FDA clearance for use in organ transplant surgery

January 23, 2008, Toronto, Canada--Novadaq Technologies has received 510(k) pre-market notification clearance from the FDA for use of its SPY imaging system during organ transplant surgery.

January 23, 2008, Toronto, Canada--Novadaq Technologies has received 510(k) pre-market notification clearance from the FDA for use of its SPY imaging system during organ transplant surgery. The SPY System is the first fluorescent imaging system available for use during very complex, technically demanding surgeries such as heart, liver, pancreas and kidney transplants. SPY enables surgeons performing life saving transplants to visualize blood flow in co-joined vessels which are responsible for providing adequate blood supply and the quality of blood perfusion to the new organ.

"Intra-operative fluorescence imaging using the SPY System has opened a new portal in transplant surgery. Potentially, the days of qualitative assessment of organ appearance, pulse quality, and simple quantitative vascular flow measurements using electromagnetic devices as the sole measurement of an organ transplant are limited," said Dr. Edmund Q. Sanchez, Assistant Director of Transplantation Services, Baylor University Medical Center in Dallas, TX. "Our familiarity study of SPY in liver, kidney, and pancreas transplant has demonstrated many potentially beneficial aspects of intra-operatively assessing organ perfusion through imaging. The success of organ transplantation is highly dependent on vascular patency and allograft perfusion. The SPY System has allowed intra-operative visualization of both immediately after reperfusion. The utility of SPY imaging organ transplantation is clearly evident."

The creation and maintenance of adequate blood supply to the newly transplanted organ or "allograft" is critical to the ultimate success of the transplant surgery. Inadequate blood flow can lead to serious complications such as organ thrombosis and allograft failure. The United Network for Organ Sharing reports that while outcomes following transplantation have improved over the years, allograft loss is a problem ultimately confronted by many recipients. For such patients, repeat transplantation often provides the best chance for survival and good health.

Retransplantation offers hope, but according to previous studies have demonstrated that outcomes following repeat transplantation are in general, inferior to those observed with first transplants. Since every organ used for repeat transplantation represents an opportunity that cannot be directed to another candidate, the potentially expanding role of retransplantation has been of growing concern. Use of the SPY System may allow surgeons to quickly identify areas of inadequate blood perfusion and potentially make immediate technical revisions which ultimately may save the organ, improve outcomes and reduce the overall costs of recovery.

"Organ transplant is a life saving operation and often offers the only hope for patients suffering from organ failure," said Dr. Arun Menawat, president and CEO of Novadaq. "The lack of available donors makes the use of each organ and the success of each transplant critical not only to the patient undergoing the transplant, but for those on the waiting list as well. The use of SPY has been shown to improve the opportunity for technically perfect surgeries which may save the new organ and in turn improve clinical outcomes for patients, prevent life threatening complications, reduce the need for retransplant and overall reduce costs. This new indication for SPY along with previously cleared indications in cardiovascular and plastic and reconstructive surgery gives hospitals a complete solution for performing imaging in the operating room during complex procedures."

In addition to the clearance for organ transplant, Novadaq has also received a broader indication for the use of SPY in cardiovascular surgery, beyond the originally cleared indication in coronary artery bypass.

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