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Atairgin

Technology
Bacchus focuses on the treatment of occlusive vascular disease with new devices for Interventional Radiologists, Cardiologists, and Vascular Surgeons. Bacchus currently has two fully developed devices: the Solera, already approved by the Food and Drug Administration for the removal of blood clots in hemodialysis vascular grafts, and the Trellis, a drug-delivery and mechanical-assist catheter, engineered to disrupt blood clots in peripheral vessels. Other devices are in development to treat deep vein thrombosis and coronary artery thrombosis. The Solera is a mechanical device that breaks apart clots within a protective basket that shields the vessel wall from injury. The end of the Trellis catheter has two balloons that are inflated on either side of blood clots, thus isolating the clot and restricting any residual blood flow. A pharmaceutical clot-dissolving agent is then released within this confined area, rather than throughout a patient's entire vascular system. The agent is mixed within the clot mass and the clot is further disrupted by means of mechanical agitation contained within the catheter. Suction removes the dissolving clot, the balloons are deflated, and blood flow resumes through the vessel.

Vascular Occlusions
Blood vessel occlusions cause strokes, heart attacks, and cut off blood supply to limbs, causing more deaths in Americans than any other disease state. Worldwide, 3.6 million patients suffer from blocked vessels, translating into a $2.6 billion market. Surgeons have treated occlusions with bypass surgery or even limb amputation. Cardiologists and Radiologists have used a concert of devices that break apart the clots, and, more recently, pharmaceutical agents - thrombolytics - to dissolve them. The use of thrombolytics is rapidly increasing, as they offer physicians a method of attacking occlusions without hazarding the high risk of injury to the vessel wall caused currently by aggressive mechanical devices. However, because thrombolytics must be administered throughout a patient's entire vascular system, there is a constant threat of internal bleeding and strokes at sites unrelated to the occlusion. Patients must remain in a hospital for careful monitoring whenever a thrombolytic is employed. The Trellis offers physicians the opportunity to employ these powerful agents, but on an out-patient basis, within hours, vastly decreasing the prohibitive costs of the long hospitalizations required today.

Clinical Success
The Solera device has been tested in ten patients with a success rate of 100% vessel patency. Bacchus was able to demonstrate that the patients had no signs of damage to blood vessels or vein leaflets. The Trellis has been applied to eleven patients. For all of the patients, "primary patency," was established, meaning that blood flow was restored through the vessels. In five of the cases, no further treatment was necessary; the establishment of primary patency by the Trellis in the other patients enabled them to receive the adjunctive therapy necessary to eventually reach full vessel patency.

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