Novadaq's SPY System receives clearance for use in organ transplant surgery
TORONTO, Jan. 17 /CNW/ - Novadaq(R) Technologies Inc. (TSX: NDQ), 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."
Read the full press release.
Low one-year survival rate for U. Hospital lung transplants prompts inspection
From The Salt Lake Tribune in Utah - For University Hospital's lung transplant program, 2004 was a tough year. Twelve people -some considered high risk - got new lungs; half died within a year of their transplant.
Today, it is still dragging the U.'s survival statistics below the national average, and has the hospital turning the riskiest patients away.
The Scientific Registry of Transplant Recipients' latest data, released Friday, shows the U.'s average one-year survival rate for the years 2004 through 2006 was 59 percent, compared with the United Network for Organ Sharing's (UNOS) expected survival rate of 85 percent.
Barbara Cahill, medical director of lung transplantation and a pulmonary critical care physician, said because the U. had such a small volume of patients between 2004 and 2006, the numbers were skewed.
In 2005 and 2006, for instance, the U. performed only six and four transplants, respectively - numbers low enough to prompt a two-day visit in December from UNOS, which has the authority to revoke a program's certification as a transplant center.
"They [2003 and 2004] were bad years for us in terms of outcome, in terms of patient deaths," Cahill said, "and I can assure you it has been pretty fully vetted at both the regional and national level, and personal inspection level." Read the full article.
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