RITA Medical Announces FDA 510(K) Clearance of Habib(TM)4x Resection Device
The HABIB4X Resection device is also labeled with the CE Mark for distribution in Europe and is currently marketed by the Company's international distribution network. Given the timing of the approval from the FDA and the requirements of a product launch in the U.S., the Company expects to begin shipping the product in mid-September 2005. In Europe, the Company has seen positive interest in the device from surgeons who routinely perform liver resection procedures and believes that similar surgeons in the U.S. market will also be interested in using the device.
"The FDA marketing clearance for the HABIB4X Resection device represents another critical milestone in the execution of our long-term strategy," said Joseph DeVivo, President and CEO of RITA Medical. "With our focus on cancer therapies, we expect the HABIB4X to be a strong addition to our product portfolio and for it to be of interest to the surgery, oncology, and cancer communities which include existing as well as many potential new customers."
The HABIB4X 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 liver cancer surgeries as it is designed to minimize blood loss and blood transfusion during surgery. Additionally the HABIB4X is designed to work on the current RITA RFA platform of 1500X Generators.
The HABIB4X Resection device is designed to be used in surgical procedures for the resection of tissue and includes the following features:
- Bi-polar electrode device designed for fast tissue ablation and coagulation
- Automatic operation with RITA 1500X Generator software upgrade
- Designed to minimize blood loss during surgical tissue resection
- Designed to reduce costs associated with resection procedures
About RITA Medical Systems, Inc.
RITA Medical Systems develops, manufactures and markets innovative products for cancer patients including radiofrequency ablation (RFA) systems 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; safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The proprietary RITA 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 RITA Medical Systems website is at www.ritamedical.com.
Safe Harbor
The statements in this news release related to the performance of the new HABIB4X Resection device, physician adoption of the HABIB4X Resection device, and the technological achievements of the HABIB4X 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. Information regarding these risks is included in the Company's filings with the Securities and Exchange Commission.
SOURCE RITA Medical Systems, Inc.
08/18/2005
CONTACT: Stephen Pedroff, VP Marketing Communications of RITA Medical
Systems, Inc., +1-510-771-0400, or spedroff@ritamed.com; or investors, Doug
Sherk of EVC Group, +1-415-896-6820, or dsherk@evcgroup.com, for RITA Medical
Systems, Inc. or Jennifer Beugelmans of EVC Group, +1-415-896-6820, for RITA
Medical Systems, Inc.; or media, Steve DiMattia of EVC Group, +1-646-277-8706,
or sdimattia@evcgroup.com, for RITA Medical Systems, Inc.
Web site: http://www.ritamedical.com
(RITA)