Healthcare Industry News: Patent foramen ovale
News Release - October 22, 2007
Sutura Continues Successful Human Trials of SuperStitch EL in Multiple Human Procedures to Suture PFO'sFOUNTAIN VALLEY, CALIFORNIA--(Healthcare Sales & Marketing Network)--Oct 22, 2007 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB ), an innovative developer of minimally invasive vascular suturing devices, today announced the successful human use of the SuperStitch EL in three patients to deliver a suture to the septum that separates the left and right atriums of the heart. Dr Michael Mullen placed the sutures into the septum to close defects known as a Patent foramen ovale (PFO).
The three successful procedures were performed at the Eskisehir Osmangazi University Hospital in Eskisehir, Turkey by Dr. Michael Mullen, of the Royal Brompton Hospital, London and Dr. Omer Goktekin who interned with Dr. Mullen at Royal Brompton. The SuperStitch EL was placed into the PFO using fluoroscopic and Intra-Cardiac Echocardiography (ICE) guidance (Siemens Cypress system). The suture was placed into the two flaps that make up the septum and then drawn together. The patients had all previously suffered strokes from their PFO's.
Dr. Mullen commented, "These cases confirm that we can accurately identify the septal structures and position the suture in each septum. We also made significant advances in the technique and learning curve. With any new procedure developing the technique is as critical as developing the system. These cases and the follow up results of the case in Georgia demonstrate that we can place a suture in the secundum and primum septums and close a PFO. The significance to the treatment of Structural Heart Disease is immense; now we are able to close a PFO without implanting a mechanical device into the heart, and eliminate the need for lifelong medication regiments."
Dr. Goktekin commented, "This was an exciting and unique opportunity for myself and our institution to participate in what will be a historical advance in cardiology." Dr. Goktekin added, "One of the greatest advantages of this technology is the ability to perform the procedure and not suffer the complications associated with device placement."
Also present for the case was Dr. Anthony Nobles, Chief Scientific Officer at Sutura. "We are honored to work with such a great team and it was the perfect environment to expand our clinical experience," noted Nobles. "We incorporated several improvements learned from our initial experience in Tbilisi and they performed beyond our expectations. Additionally, we substantially improved our learning curve on the deployment and imaging which will allow us to bring this product to market."
Dave Teckman, Sutura's President and CEO added, "This is a significant step to changing the gold standard of leaving a device of any kind behind after the procedure. We believe in time this will eliminate the need for these invasive technologies and mark the introduction of a new era in the treatment of structural heart disease. Accomplishing this is a primary goal of ours 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.
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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 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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