Post-Market Registry for Isolated Thrombolysis Selected for Presentation at the Society for Vascular Surgery Annual Meeting.
CHICAGO--(BUSINESS WIRE)--June 10, 2003
Registry presents significant economic and safety advantages of
isolated thrombolysis for treatment of acute limb ischemia
Bacchus Vascular, the leading developer of innovative technology in thrombus management, today announced the presentation of the first post-market registry on isolated thrombolysis for treatment of acute limb ischemia at the Annual Meeting for the Society of Vascular Surgery and American Association for Vascular Surgery in Chicago.
Dr. Timur Sarac will present important safety, economic and efficacy improvements of isolated thrombolysis compared to standard catheter-directed thrombolysis (CDT) using the new Trellis(R) isolated thrombolytic delivery device with t-PA (Alteplase; Genentech, Inc.).
"Isolated Thrombolysis is the future in thrombolytic delivery," stated Dr. Timur Sarac, a leading endovascular surgeon with The Cleveland Clinic Foundation and primary author of the paper. "Not only is it as effective as CDT for treating patients with acute and chronic arterial occlusions, there are fewer bleeding complications as a result of the decreased infusion time and lower dosing."
The registry reviewed the technical success, bleeding complications and costs of 26 consecutive patients in 12 U.S. and European hospitals treated with Trellis for lower extremity ischemia and compared that to historical data on CDT outcomes. The mean age of patients in this registry was approximately 70 years old and 58 percent of patients treated had acute arterial occlusions, while 42 percent had chronic arterial occlusions. Approximately 69 percent were treatments on lower extremity native arteries and 31 percent were lower extremity bypass grafts.
The study found zero percent bleeding complications with Trellis versus 11 percent for standard CDT. The technical success rate for Trellis patients was 96 percent compared to 81 percent for CDT. Costs for the procedure with Trellis were also lower, with an overall mean cost of $3,216 per case compared to $4,536 for CDT.
"The cost effectiveness of Trellis when compared to traditional CDT cannot be overlooked by the healthcare community," said Dr. Dan Hilleman, professor of medicine at Creighton University, member of the Cardiology Editorial Advisory Board and fellow researcher who evaluated the economic significance of this study on healthcare systems. "I can see Trellis becoming the standard of care for treating patients with acute limb ischemia."
Limb ischemia is caused by a blockage of one or more of the blood vessels that carries blood to a limb. Catheter directed thrombolysis is a process by which thromolytic drugs such as t-PA, TNK or Urokinase are delivered directly into the occluded vessel to remove blood clots (thrombus). This blockage can either be chronic, moderate or acute. When it is acute, the limb generally becomes discolored and the patient loses sensory perception. Without immediate attention this condition, known as acute limb ischemia, can lead to the loss of a limb. In the United States, more than 100,000 cases of acute limb ischemia are diagnosed annually and require immediate medical intervention.
"This study provides further validation that Trellis provides several economic and safety improvements over traditional CDT for treating acute and chronic arterial occlusions," said Mel Schatz, president and CEO, Bacchus Vascular. "An increasing number of physicians are also discovering the benefits of Trellis in patients suffering from Deep Vein Thrombosis (DVT), where isolated thrombolysis with Trellis is safe, economically viable and effective."
In December 2002, Bacchus announced FDA clearance and commercial availability of its new Trellis(R) Reserve with I.A. (Integral Aspiration) Technology for the treatment of acute limb ischemia and DVT. The Trellis Reserve Peripheral Infusion System with I.A. Technology is a percutaneous infusion system that can isolate and treat a clot with any standard thrombolytic in as few as 15 minutes. Its unique dual-balloon system is designed to maintain the concentration of the infused fluid while its mechanical dispersion wire effectively disperses the fluid throughout the treatment area. Trellis Reserve optionally allows the physician to aspirate the treatment area, which may reduce the risk of downstream emboli.
To date, more than 200 clinical cases have been successfully completed with Trellis. Case summaries are available at www.bacchus-vascular.com. Bacchus Vascular will be exhibiting at Vascular 2003, Booth #764.
About Bacchus Vascular
Founded in 1999 by Dr. Thomas Fogarty, a noted inventor and cardiovascular surgeon, Bacchus Vascular is an emerging medical device company focused on the discovery and development of innovative treatments for cardiovascular and peripheral occlusive vascular disease. Other projected project launches in 2003 include Solera(TM) Plus for occluded dialysis grafts and Fino(TM) for removing venous clots that cause deep vein thrombosis (DVT). For more information, please visit www.bacchus-vascular.com.
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|Date:||Jun 10, 2003|
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