Healthcare Industry News: vascular access
News Release - February 28, 2006
Rita Medical Systems Launches OmniPICC PI(TM) Power Injectable Peripherally Inserted Central Catheter ProductProduct Opens New Sales Opportunity; Designed for High-Flow Rate Injections for Radiology Imaging and Interventions
FREMONT, Calif. and MANCHESTER, Ga., Feb. 28 (HSMN NewsFeed) -- RITA Medical Systems, Inc. (Nasdaq: RITA ), a publicly traded medical device company focused solely on cancer therapies, today announced the introduction of the OmniPICC PI(TM), a power injectable peripherally inserted central catheter (PICC). The OmniPICC is designed to allow clinicians to inject patients at high-flow rates of up to 5ml/sec at power injection settings of 300psi for the delivery of contrast media used to enhance the visualization of blood vessels and other biological structures during radiological imaging and interventional procedures.
The OmniPICC, now available in the United States, complements the Company's existing line of specialty access catheter products. The OmniPICC received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in November 2005 and has been in limited market release since January 2006. The Company is pursuing the CE mark for the product for distribution in Europe.
Joseph DeVivo, President and CEO of RITA Medical Systems, commented, "We believe the OmniPICC is an important addition to our line of infusion products because it is expected to allow RITA to participate in what we believe is the fastest growing market segment in vascular access. The sale of power injectable PICC lines is also expected to be incremental to our existing business." Mr. DeVivo continued, "I expect the OmniPICC to help our sales team grow our specialty access catheter business in both existing and competitive accounts."
Conventional PICC lines are routinely used for repeated and prolonged access to the venous system. The OmniPICC differs from a conventional PICC line by also allowing a physician to inject contrast media into a patient's vascular system at high flow rates. High injection pressures and flow rates are necessary to adequately disperse contrast media throughout the body. The ability to use one catheter for both venous access and to inject imaging contrast and other high-flow rate agents in patients is expected to offer multiple benefits including: patient comfort, patient safety and convenience, and cost-savings for the healthcare provider system.
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; and safety infusion sets and peripherally inserted central catheters used primarily in cancer treatment protocols. The 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 RITA Medical Systems website is at www.ritamedical.com.
The statements in this news release related to the performance of the new OMNI PICC, physician adoption of the OMNI PICC, and the technological achievements of the OMNI PICC, the size of the market segment in vascular access and the effect of the OMNI PICC on the Company's sales of specialty access catheters are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those is such forward-looking statements. Such risks and uncertainties include bur are not limited to: market acceptance of any new products or services of the Company; competitive pressures; physician training efforts; the Company's dependence on its line of specialty access catheters to achieve its sales goals and profitability targets; the Company's historical and future operating results and profitability; and general economic and political conditions. 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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