Healthcare Industry News: peripherally inserted central catheter
News Release - November 30, 2006
RITA Medical Systems Announces Market Release of Habib 4X Laparoscopic(TM)Newly Introduced Laparoscopic Surgical Device Designed to Reduce Blood Loss, Decrease Operating Times, Coagulate Highly Vascularized Tissue
FREMONT, Calif., Nov. 30 (HSMN NewsFeed) -- RITA Medical Systems, Inc. (Nasdaq: RITA ), a publicly-traded medical device company focused solely on cancer therapies, today announced the start of market release shipments of the Habib 4X Laparoscopic(TM) resection device. The Habib 4X Laparoscopic uses radiofrequency (RF) energy to coagulate tissue and is designed to assist surgeons to reduce blood loss and decrease operating times during laparoscopic resection of vascularized tissue.
Alan J. Koffron, MD, Assistant Professor of Surgery, Division of Organ Transplantation, Northwestern Memorial Hospital in Chicago, Illinois stated, "Controlled transection of the liver parenchyma (and therefore reduction of blood loss) during laparoscopic liver resection is critical to patient safety and can often be the determining factor when deciding to perform either traditional open surgery or minimally invasive procedures. My early clinical experience with the device has been striking in regard to liver transection, and I believe that its use will make it possible for me to offer the benefits of minimally invasive surgery to more of my patients."
The Habib 4X Laparoscopic resection device coagulates a surgical resection plane to facilitate a fast dissection with limited blood loss. The Company believes this technology will be utilized in a variety of cancer surgeries, including liver and kidney, as it is designed to minimize blood loss and the need for blood transfusion during or after resection. The Habib 4X Laparoscopic resection device is designed to work on the current RITA RFA platform of 1500X(TM) Generators.
Joseph DeVivo, President and CEO of RITA commented, "We believe the laparoscopic Habib has the opportunity to become a useful surgical tool across a broad range of procedures. The early clinical use of the device, while focused on liver resection, is only the beginning of what we believe will be broad-based clinical application by laparoscopic surgeons."
Mr. DeVivo concluded, "We are grateful to thought-leaders like Dr. Koffron and his team who were instrumental in defining the best practices for early use of the device. We believe that these talented clinicians will continue to explore applications of laparoscopic resection and the benefits of rapid tissue coagulation in other organs and other procedures."
The Habib 4X Laparoscopic is CE marked for distribution in Europe, and was cleared for use to assist in coagulation of tissue during intraoperative and laparoscopic surgical procedures by the U.S. Food and Drug Administration (FDA) in October of 2006.
About RITA Medical Systems, Inc.
RITA Medical Systems develops, manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems and embolization products for treating cancerous tumors as well as percutaneous vascular and spinal access systems. The Company's oncology product lines include implantable ports, some of which feature its proprietary Vortex® technology; tunneled central venous catheters; and safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The radiofrequency product line also includes the HABIB 4X resection device which coagulates a "surgical resection plane" and is designed to facilitate a fast dissection in order to minimize blood loss and blood transfusion during surgery. The proprietary RITA RFA system uses radiofrequency energy to heat tissue to a high enough temperature to ablate it or cause cell death. In March 2000, RITA became the first RFA company to receive specific FDA clearance for unresectable liver lesions in addition to its previous general FDA clearance for the ablation of soft tissue. In October 2002, RITA again became the first company to receive specific FDA clearance, this time for the palliation of pain associated with metastatic lesions involving bone. The Company also distributes LC Bead(TM) embolic microspheres in the United States. The LC Bead microspheres are injected into selected vessels to block the blood flow feeding a tumor, causing it to shrink over time, and are often used in combination with RFA. The RITA Medical Systems website is at www.ritamedical.com.
The statements in this news release related to the introduction of the HABIB 4X Laparoscopic resection device; the use of the laparoscopic version of the HABIB 4X resection device in surgeries involving organs other than the liver; the performance of the HABIB 4X Laparoscopic resection device; and physician adoption of the HABIB 4X Laparoscopic Resection device are forward- looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Such risks and uncertainties include but are not limited to: the risk of product defects, recalls or failures; potential product delays caused by unforeseen manufacturing challenges; reliance on a small number of suppliers for components of the HABIB 4X Laparoscopic resection device; compliance with FDA regulations; and physician training efforts. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
Source: RITA Medical Systems
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