Navigation Links
Novadaq's SPY System receives clearance for use in organ transplant surgery
Date:1/17/2008

TORONTO, Jan. 17 /PRNewswire-FirstCall/ - 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."

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.

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, please visit the company's website at http://www.novadaq.com.

Forward looking Statements

Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Novadaq's current beliefs as well as assumptions made by and information currently available to Novadaq and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Novadaq in its public securities filings; actual events may differ materially from current expectations. Novadaq disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Novadaq Technologies Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Speedy Procedures Demonstrate Excitement and Continued Interest in Novel Multi-Electrode Ablation System
2. Specialized System Speeds Heart Attack Treatment
3. Engaging 2008 Debate, Key Long Term Care Advocacy Groups Offer New Plan to Strengthen Nations Long Term and Post-Acute Care Delivery System
4. BeneChills RhinoChill System Receives CE Marking for European Commercial Sale
5. e-Health Card Terminal From SCM Microsystems Receives GEMATIK Certification
6. Lake Forest Hospital Proposes a New Health Care System in Lake County
7. CBaySystems and M*Modal Enter Strategic Partnership
8. Jefferson scientists find protein helps pancreatic cancer cells evade immune system and spread
9. Common molecule notifies immune system of prostate cancer
10. New computed tomography system marketed
11. Physicians Want to Learn From Medical Mistakes But Say Current Error-Reporting Systems are Inadequate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/19/2017)... Charleston, South Carolina (PRWEB) , ... February 19, 2017 , ... ... class of evening undergraduate nursing students, is being led by Amelia Joseph, Ph.D. Joseph ... direct the initial operations of the nursing department in early 2016. After a nation-wide ...
(Date:2/19/2017)... (PRWEB) , ... February 19, 2017 , ... ProBrand Glitch is a set of 30 ... ProBrand Glitch users can easily reveal any logo with a glitch reveal in just a ... control over the style and animation of each preset. Use these presets to add a ...
(Date:2/19/2017)... ... February 19, 2017 , ... ... healthcare, will join forces with Healthwise ® at HIMSS 2017 ... industry leader in evidence-based health education, technology and services, will demonstrate a voice-powered ...
(Date:2/18/2017)... ... February 17, 2017 , ... Focused start-ups, not ... the industry, according to the recent NEJM Catalyst Insights Report on the New ... NEJM Catalyst Insights Council, a qualified group of U.S. executives, clinical leaders, and ...
(Date:2/18/2017)... ... February 17, 2017 , ... ... drvallecillos.com , Beverly Hills plastic surgeon Dr. Glenn Vallecillos experiments ... Dr. Vallecillos says, "Traditionally, plastic surgery has been centered around that idea that ...
Breaking Medicine News(10 mins):
(Date:2/20/2017)... 21, 2017 Taiwan Biophotonic Co. (tBPC), a ... vital signs sensing solutions, today announced the CE Marking ... pulse oximeter, the oCare TM Pro 100, which is ... medical devices space.  tBPC,s Wrist Pulse Oximeter, ... simple and reliable method to measure and record heart ...
(Date:2/20/2017)... , Feb. 20, 2017 Provides understanding ... agreements entered into by the worlds leading healthcare ... Description The Global Anemia Partnering Terms ... access to partnering deals and agreements entered into ... - Trends in partnering deals - Top ...
(Date:2/20/2017)... , Feb. 20, 2017  This Report analyzes the worldwide ... Dosage Forms: Injectables, Solid Dosage Forms, and Liquid & Semi-solid Dosage ... Canada , Japan , ... World. Read the full report: http://www.reportlinker.com/p04707109-summary/view-report.html ... Annual estimates ...
Breaking Medicine Technology: