BACCHUS VASCULAR'S TRELLIS RESERVE ISOLATED THROMBOLYSIS SYSTEM RECEIVES FDA 510(k) CLEARANCE SANTA CLARA, Calif., December 9, 2002

Bacchus Vascular today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Trellis Reserve System with Integral Aspiration (IA) Technology.

This 510 (PRWEB) December 13, 2002

Dr. Timur Sarac from Cleveland Clinic commented; The release of the Trellis Reserve is a monument in the treatment of patients with peripheral arterial disease and deep venous thrombosis (DVT). The Trellis is the next logical step in developing minimally invasive techniques for interventional radiologic and vascular surgical procedures. It is not only safe for the patient, but offers several advantages for patients with regard to length of treatment, decreased hospital stay, cost, and bleeding complications."

The Trellis Infusion Catheter is a minimally invasive system designed to facilitate the delivery of physician specified agents, including thrombolytics (clot-dissolving drugs), into the peripheral vasculature (the arteries and veins in upper and lower limbs) and evacuation of treated area. This break-through technology is based upon the Companys percutaneous isolated accelerated lysis platform. The Trellis system does not require capital equipment.

Arizona Heart Institutes Dr. Venkatesh Ramaiah stated that, the Trellis Reserve with IA Technology is the only device with an integral embolic protection system and the ability to isolate thrombolytic infusion in combination with mechanical thrombus dissolution. Advantages of the Trellis system include isolation of the occluded segment, prevention of proximal or distal thrombus embolization, avoidance of systemic release of the thrombolytic agent, rapid revascularization of the treated limb, decreasing or completely eliminating the need for ICU stay, and early identification and treatment of the culprit lesion with PTA and stenting."

Worldwide, over 200 patients have been treated with the Trellis Catheter with no major reported bleeding complications. The Trellis Reserve System is a significant improvement to the previous generation Trellis System because it allows a physician to aspirate within the 6 French Trellis catheter, thereby minimizing the need for a coaxial sheath.

As Dr. Thomas J. Fogarty commented, The Trellis System works with any thrombolytic on the US market and requires less than 20% of the standard catheter-directed thrombolysis (CDT) dosage. The minimal amount of thrombolytic that the Trellis system requires for its safe and efficacious clot removal, translates into a safer method of delivering thrombolytics into the vasculature. By administering significantly lower amounts of thrombolytics, isolating the treatment area, and aspirating the infused area, may allow physicians to use it in patients that are contra-indicated for systemic thrombolytic agents. This shows a major improvement over catheter-directed thrombolysis procedures that have a reported bleeding complication rate of 5-15%, which includes cerebral hemorrhage. The Trellis is an enabling technology that significantly increases the number of patients with limb ischemia and DVT that can be treated with thrombolytic drugs."    

The Trellis technology is based upon patented, isolated, accelerated lysis technology, which facilitates extremely efficient, localized mixing of infused fluids. We are very excited about receiving 510(k) clearance of the Trellis Reserve System," said Mel Schatz, CEO and President of Bacchus Vascular, we are confident that the Trellis Reserve will capture significant market share due to its unique benefits it offers to both the patient and the physician."

About Bacchus Vascular:

Bacchus Vascular Inc. is a rapidly emerging company focused on the discovery and development of innovative treatments for cardiovascular and peripheral vascular occlusive disease. Renowned inventor and physician Thomas J. Fogarty, M.D, founded Bacchus Vascular in 1999. Dr. Fogarty has over forty years of experience in the development of embolectomy and thrombectomy products. Dr. Fogarty has pioneered the field of minimally invasive surgery through his inventions and in the process redefined how cardiovascular, vascular, and general surgeries are performed today. Since inception, Bacchus Vascular has developed two different and innovative lines of patented percutaneous thrombus management products: a mechanical system and pharmacomechanical system. The company believes that it is strategically well positioned for leveraging its technology into becoming the Market Leader in Percutaneous Thrombus Management.

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