Healthcare Industry News: Patent Foramen Ovale
News Release - September 26, 2007
Sutura Reports First Patient to Receive Superstitch EL Showing No Left-To-Right ShuntFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Sep 26, 2007 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), an innovative developer of minimally invasive vascular suturing devices, announced today that the first patient to receive a SuperStitch EL to close a Patent Foramen Ovale (PFO) is showing no left-to-right shunt. Doctors at Republic Hospital in Tbilisi, Georgia performed a Tranesophageal Echo (TEE) on the patient and reported that the 19-year-old female patient is clinically doing well one month after the closure of the PFO using the SuperStitch EL.
"The patient not only is asymptomatic and doing well clinically, but now the TEE with bubble-contrast study at one month post closure confirms that a single stitch delivered percutaneously by a transcatheter technique is feasible. This new revolutionary technique may indeed initiate a paradigm shift in the rational approach to how and to whom PFO should be closed," commented Dr. Carlos E. Ruiz, Director, Structural and Congenital Heart Disease at Lenox Hill Hospital, New York.
Dr. Nicholas Kipshidze, Physician in Chief and General Director of the Central University Hospital in Tblisi, Georgia and Director of Preclinical Research, Lenox Hill Hospital in New York, who along with Dr. Irakli Gogorishvili collaborated on the first human case with Drs. Carlos E. Ruiz and Michael Mullen, reported the successful results.
Dr. Carlos E. Ruiz, and Dr. Michael Mullen, Royal Brompton Hospital, London are both members of Sutura's Clinical Advisory Board.
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 ability of the company to raise additional funds necessary for the continued operation of the company, acceptance of the SuperStitch® and HeartStitch® devices by medical providers and the marketplace in general, the ability of the company to establish successful strategic relationships or to complete strategic transactions with third parties, 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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