Sutura Receives 510k Clearance to Market Guidewire Version of SuperStitch.FOUNTAIN VALLEY, Calif. -- Sutura, Inc. ("Sutura") (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :SUTU SUTU Subsea Umbilical Termination Unit ), a California-based medical device company, announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for use of the pre-loaded guidewire version of its patented SuperStitch vascular suturing device. The guidewire version of the SuperStitch allows physicians to re-access a vessel during procedures by placing the sutures first and complete suturing the vessel after performing additional procedures if they choose. The guidewire version also enables physicians to use the SuperStitch GW on patients where they feel that maintaining access is more crucial. Anthony Nobles, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Sutura stated, "This design was developed in consultation with Dr. Alan Heldman at Johns Hopkins and at the request of our customers. The 510(k) clearance of the SuperStitch GW version, complements our SuperStitch line of marketed products as we continue to roll out the SuperStitch to Cath Labs and medical facilities worldwide. The SuperStitch GW expands the potential use of our patented technology and should enable physicians to deploy the device in a larger number of cases." Tom Lindsey, Director of Sales and Marketing for Sutura stated, "This not only adds another product to the portfolio, we expect that this will strengthen the competitive position of Sutura's SuperStitch vascular suturing devices." Recently the Company announced that it expanded its SuperStitch sales force and had introduced the SuperStitch to 75 key medical facilities in the U.S. The introduction of the SuperStitch to these key medical facilities is a significant milestone for Sutura, among these facilities are some of the top medical institutions, universities, training facilities and cardiology centers in the country. About Sutura, Inc. Sutura(R), Inc. (www.suturaus.com) is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture suture /su·ture/ (soo´cher) 1. sutura. 2. a stitch or series of stitches made to secure apposition of the edges of a surgical or traumatic wound. 3. to apply such stitches. 4. the puncture created in arteries during open surgery and catheter-based procedures. The Company's line of SuperStitch medical devices provide sutured closure of the arteriotomy site utilizing the existing catheter sheath introducer or cannula cannula /can·nu·la/ (kan´u-lah) a tube for insertion into a vessel, duct, or cavity; during insertion its lumen is usually occupied by a trocar. can·nu·la or can·u·la n. pl. during fluoroscopically guided procedures and directly through the open arteriotomy during open surgical procedures. Within the United States the 8F & 6F SuperStitch devices are available for use in performing vascular stitching in general surgery, including endoscopic en·do·scope n. An instrument for examining visually the interior of a bodily canal or a hollow organ such as the colon, bladder, or stomach. en procedures. It is not intended for blind closure of an arteriotomy site. The SuperStitch 8F & 6F is approved in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community and CE marked with the indication for use as follows: The SuperStitch is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. In the EU there is no requirement for the use of fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography guidance. Sutura's headquarters are in Fountain Valley, California Fountain Valley is a city in Orange County, California, United States. The population was 54,978 at the 2000 census. History The city was incorporated in 1957, before which it was known as Talbert (also as Gospel Swamp). . "Sutura(R)" and "SuperStitch(R)" are registered trademarks of Sutura, Inc. Forward-Looking Information Is Subject to Risk and Uncertainty Certain statements in this press release may contain projections or "forward-looking" information (as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995) that involve risk and uncertainty. The words "aim", "plan", "likely", "believe", "expect", "anticipate", "intend", "estimate", "will", "should", "could", "may", "appears", and other expressions that indicate future events and trends identify forward-looking statements. These statements are not guaranties of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are based upon assumptions as to future events that may not prove to be accurate. Actual outcomes and results may differ materially from what we express or forecast in these forward-looking statements. As a result, these statements speak only as of the date they were made and we undertake no obligation to publicly update or revise any forward-looking statements. Our actual results and future trends may differ materially from our forward-looking statements depending on a variety of factors including the acceptance of the SuperStitch(R) devices by medical providers and the marketplace in general and the success of the proposed sales and marketing plan, the continued growth of the vessel closure marketplace and the company's ability to continue to expand and protect its technology patents. Sutura, Inc. (OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. :SUTU) |
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