Press Releases
Bacchus Vascular Announces the U.S. Clearance for the TRELLIS®-8 Isolated Thrombolysis Catheter
Santa Clara, CA – March 28, 2005 – Bacchus Vascular, Inc. announces the recent U.S. Food and Drug Administration (FDA) clearance of the TRELLIS®-8 Peripheral Infusion System. The TRELLIS-8 is an advanced drug infusion catheter designed for the treatment of Deep Vein Thrombosis (DVT) and Arterial Occlusions by enabling targeted delivery of clot-dissolving drugs. The TRELLIS-8 clearance is for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
"Interventionalists are demanding a tool to treat DVT efficiently and cost-effectively," said Dr. Thomas Fogarty, Stanford cardiovascular surgeon and founder of Bacchus Vascular. "Our engineers designed the TRELLIS-8 to treat DVT in a single procedure and not require a hospital to invest in capital equipment."
The TRELLIS-8 is an advanced drug infusion catheter with two occluding balloons, drug infusion holes between the balloons and mechanical drug dispersion capabilities. This pharmaco-mechanical combination enables Isolated Thrombolysis, or targeted delivery and increased penetration of clot-dissolving drugs (thrombolytics) into a blood clot. The TRELLIS-8 is introduced through a small percutaneous incision and is fully disposable. Interventional radiologists and vascular surgeons are the primary physician specialties who would use the TRELLIS-8.
Deep Vein Thrombosis (DVT) is a blood disorder resulting from the formation of a blood clot (thrombus) inside a deep vein of the leg, commonly located in the calf or thigh. DVT occurs when the blood clot either partially or completely blocks the flow of blood in the vein. Patient symptoms include pain, swelling, and discoloration. Approximately 400,000 - 600,000 new DVT cases are diagnosed each year in the United States. The majority of patients diagnosed with DVT are treated with anticoagulation therapy alone. While this therapy reduces the risk of fatal pulmonary embolism and further blood clot formation, the underlying blood clot may remain and cause permanent vein damage and postthrombotic syndrome. Preliminary clinical data with other blood clot removal techniques indicates that early removal of venous blood clots as a compliment to anticoagulation improves patient outcomes including the reduction of postthrombotic syndrome.
"The medical community is becoming more aware that advanced DVT treatment options are available," said Dr. Mahmood Razavi, Interventional Radiologist from Sequoia Hospital in Redwood City, CA. "I expect interventionalists to increase their outreach within their hospitals and communities regarding the TRELLIS-8 and its implications for treatment of DVT." Dr. Razavi will be presenting on Trellis technology for treatment of DVT at the upcoming Society of Interventional Radiology meeting in New Orleans on Friday April 1, 2005.
Bacchus Vascular, Inc. is a venture-backed medical device company dedicated to the treatment of occlusive vascular disease. Dr. Thomas Fogarty, a noted inventor and cardiovascular surgeon, founded the company with the vision of transforming blood clot removal into a fast, simple, and minimally-invasive procedure.
Patients and physicians should feel free to visit www.bacchusvascular.com for more information on the TRELLIS-8 or Bacchus Vascular, Inc.
Media Contact
Scott Rader
President
408-980-8300, ext. 217
srader@bacchusvascular.com