Healthcare Industry News: Patent Foramen Ovale
News Release - September 6, 2007
First Human Patient to Receive Sutura's SuperStitch EL to Close a Patent Foramen Ovale Discharged From HospitalFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Sep 6, 2007 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), an innovative developer of minimally invasive vascular suturing devices, today announced that the first patient to receive a SuperStitch EL to close her Patent Foramen Ovale (PFO) has been discharged from hospital. Dr. Nicholas Kipshidze, Physician in Chief and General Director of the Central University Hospital in Tblisi, Georgia and Director of Preclinical Research, Lennox Hill Hospital in New York, who along with Dr. Irakli Gogorishvili performed the first human case with Drs. Carlos Ruiz and Michael Mullen, announced that the 18-year-old patient was discharged the day after the procedure and was able to celebrate her 19th birthday at home having had her PFO successfully closed with the Supersitch EL.
Dr. Nicholas Kipshidze, who collaborates with Carlos Ruiz at Lennox Hill and at Central University Hospital, Tblisi, stated that two weeks after the procedure the patient is currently non-symptomatic and resting at home. Dr. Kipshidze added, "We are excited and pleased to be the Center chosen for this historical procedure. This exemplifies the cooperation we have between Lennox Hill Hospital and Central University Hospital in Tblisi, Georgia in pioneering new technologies by providing state of art health care around the world."
"We believe this is a substantial step forward for our technology, however more patients and longer term follow up will be required to broadly commercialize the product," said Dr. Anthony Nobles, Chairman and Chief Scientific Officer at Sutura.
"Sutura is very proud to have worked with Drs. Nicholas Kipshidze and Irakli Gogorishvili and their impressive staff at Central University Hospital in Tblisi, Georgia," commented Dave Teckman, President and CEO at Sutura.
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 a 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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