Novadaq Technologies’ (Toronto) SPY imaging system has received FDA 510(k) clearance for organ transplant surgery, allowing surgeons to visualize blood flow to the new organ while the patient still is on the operating table.

The creation and maintenance of adequate blood supply to the newly transplanted organ is critical to the success of transplant surgery. Inadequate blood flow can lead to serious complications such as organ thrombosis and allograft failure.

“Our product allows visualization of blood flow to any organ,” Arun Menawat, PhD, president/CEO of Novadaq, told Medical Device Daily. “When they do transplant surgeries, they are interested in knowing the quality of the organ and whether or not it’s receiving the blood supply. Once they confirm that, they want to know if the blood is perfusing properly to all areas of the organ.”

SPY use in transplant surgery is expected to create endpoints for the surgery that allows surgeons to quickly assess whether or not the transplant has been successful.

“Over the long term, this should facilitate more organ transplants,” Menawat said.

SPY was originally cleared by the FDA in 2005 for use in coronary artery bypass graft surgery. Last year, Novadaq increased its sales team to facilitate more SPY sales in the U.S. (Medical Device Daily, Jan. 29, 2007). Menawat said 100 units already are installed in U.S. hospitals.

“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 Edmund Sanchez, assistant director of transplantation services at Baylor University Medical Center (Dallas).

“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,” he said. “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.”

SPY has a camera head that is arrayed on an articulating arm to facilitate use for different parts of the body.

Although transplant outcomes have improved over the years, the agency that regulates transplantation centers in the U.S. — United Network for Organ Sharing (Richmond, Virginia) — reports that allograft loss is a problem ultimately confronted by many recipients. Repeat transplantation often provides the best chance for survival and good health for many patients, but outcomes are often inferior to those observed with first transplants.

“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,” Menawat said. “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.”

In 2006 there were 28,931 transplants performed in the U.S. and today, more than 94,000 patients suffering from organ failure are waiting lists.

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