Healthcare Industry News: Patent foramen ovale
News Release - August 27, 2007
Top PFO Specialists Perform First Human Placement of Sutura's SuperStitch EL To Close a Patent Foramen OvaleFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Aug 27, 2007 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), an innovative developer of minimally invasive vascular suturing devices, announced today the first use of the SuperStitch EL in a human patient to deliver a suture to the septum that separates the left and right atriums of the heart. Dr.'s Carlos E. Ruiz and Michael Mullen placed the suture into the septum to close a defect known as a Patent foramen ovale (PFO).
The procedure was successfully performed at the Republic Hospital in Tbilisi, Georgia by Dr. Carlo E. Ruiz, Lennox Hill Hospital, New York and Dr. Michael Mullen, Royal Brompton Hospital, London, both members of Sutura's Clinical Advisory Board. The SuperStitch EL was placed into the PFO using fluoroscopic and Intra-Cardiac Echocardiography (ICE) guidance. The suture was placed into the two flaps that make up the septum and then drawn together to close the large defect. The 18-year-old patient had suffered from severe migraines with auora and has suffered recurring strokes, both symptoms associated with the PFO.
Dr. Ruiz commented, "This first human case demonstrates that the SuperStitch EL technology can successfully place a suture to close a PFO. This is a significant milestone in the treatment of structural heart disease - to be able to close a PFO without implanting a synthetic device into the heart and without the potential long term complications associated in placing current devices."
Dr. Mullen commented, "This is an exciting new treatment for PFO closure and could prove to be the next generation in the treatment of structural heart disease. The Patient was not given post procedural Plavix. This is a significant benefit to this technology over current implantable devices. The use of the SuperStitch EL also provides PFO patients with an alternative to open heart surgery."
Also present for the case was Dr. Anthony Nobles, Chief Scientific Officer at Sutura. Dr. Nobles commented, "We are very excited about the success of this first case. It comes after a great deal of development work by our engineers and staff in conjunction with our clinical advisors. This success demonstrates that the SuperStitch EL can provide physicians with a suture delivery system that will close a PFO."
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.
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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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