Novadaq(R) Technologies Inc. (TSX: NDQ), Toronto, a developer of
medical imaging systems for the operating room, 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 CEO 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.
About Novadaq Technologies
Novadaq Technologies Inc. (TSX: NDQ) develops and commercializes
medical imaging systems and real-time image guided therapies for use in
the operating room. Novadaq's proprietary ICG imaging systems can
be used to visualize blood vessels, nerves and the lymphatic system
during a variety of surgical procedures. Novadaq's SPY Imaging
System, commercially available worldwide, enables cardiac surgeons to
visually assess coronary vasculature and bypass graft functionality
during the course of heart bypass surgery. The SPY System is expandable
to include upgrade kits for use during other surgeries such as plastic,
reconstructive and organ transplant surgery allowing surgeons to
evaluate blood flow and tissue and organ perfusion. In addition, SPY is
ideal for use during urological procedures enabling surgeons to
visualize vessels, tumors, the lymphatic system and potentially nerve
bundles. Novadaq's OPTTX(R) 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
Imaging System. Novadaq also offers the FDA approved PINPOINT endoscopic
system for visualizing native tissue fluorescence which allows surgeons
to differentiate between healthy and cancerous tissue in the lung during
thoracic surgery. Novadaq is also the exclusive United States
distributor of PLC Medical's CO2 HEART LASER(TM) System for TMR
(Trans-Myocardial Revascularization).
For more information, visit http://www.novadaq.com or call
905/629-3822, ext. 202.
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