Healthcare Industry News: vascular closure
News Release - October 25, 2006
Sutura Receives 510k Clearance for Expanded Portfolio of SuperStitchFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Oct 25, 2006 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), a California-based medical device company, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 12F, 5F and EL SuperStitch products.
These additional sizes allow Sutura to address several market segments unmet by its competitors. The 12F version of the device enables physicians to place sutures in larger arteriotomies that were not possible with the current products offered by the lead competitors. Additionally the company believes that the 5F and EL will open other markets currently un-served by current technologies.
David Teckman, President and CEO of Sutura stated, "These designs have been under development for several years at the request of our customers. The 510(k) clearance of the SuperStitch 5, 12 and EL devices, complements our SuperStitch line of marketed products as we continue to roll out the SuperStitch to Cath Labs and medical facilities worldwide."
Tony Nobles, Chief Science Officer for Sutura stated, "The SuperStitch 5,12, and EL expands the potential use of our patented technology and should enable physicians to deploy the device in a larger number of cases. We also believe that having these unique products will play an essential role in our ability to penetrate key accounts that have a long history with competitive devices."
About Sutura, Inc.
Sutura®, Inc. (www.suturaus.com) is a medical device company that has developed a line of innovative, minimally invasive, vascular suturing devices to suture 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 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 procedures. It is not intended for blind closure of an arteriotomy site. The SuperStitch 8F & 6F is approved in the European Union 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 guidance. Sutura's headquarters are in Fountain Valley, California. "Sutura®" and "SuperStitch®" 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 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® devices by medical providers and the marketplace in general and the success of the proposed sales and marketing plan, the ability of the company to establish a successful distribution relationship with a strategic partner, the continued growth of the vessel closure marketplace and the company's ability to continue to expand and protect its technology patents.
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