Novadaq(R) Technologies Inc., a developer of medical imaging systems for the operating room, announced today that it has received 510(k) pre-market notification clearance from the United States Food and Drug Administration (FDA) for its imaging system for use during organ transplant surgery.
Novadaq's SPY(R) 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 Chief Executive Officer Novadaq Technologies Inc. "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."
According to the United States Organ Procurement and Transplantation Network (OPTN), Transplant surgery has saved more than 300,000 lives. In 2006 there were 28,931 transplants performed in the United States and today, more than 94,000 patients suffering from organ failure are on the waiting list. Kidney transplant procedure costs can range widely but most average from $25,000 to $150,000, depending on the extent of kidney disease and whether the patient has a deceased or living donor transplant. Liver transplant procedure costs can also range, but most average between $100,000 to $400,000, depending on time in the hospital ICU and extent of liver disease before transplantation. Costs can also vary greatly depending on a number of factors including the patient's health at baseline, rate of recovery, any pre-existing conditions and/or potential complications after surgery.
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.