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Royal Brompton Cardiologist Successfully Performs PFO Closures Using Sutura's SuperStitch EL Wednesday May 14, 4:39 pm ET
FOUNTAIN VALLEY, CALIFORNIA--(MARKET WIRE)--May 14, 2008 -- Sutura, Inc. ("Sutura") (OTC BB:SUTU.OB - News), a California-based medical device company, announced today that Dr. Michael Mullen, lead clinician for interventional cardiology at Royal Brompton Hospital in London, performed two successful PFO closures using the newly released SuperStitch EL. Dr. Mullen is a member of Sutura's Clinical Advisory Board, and is currently consultant cardiologist and Director of the Cath Lab at Royal Brompton, specializing in adult congenital interventional catheter laboratory procedures. ADVERTISEMENT
Dr. Mullen placed a single suture across and through the vascular structure of the PFO and closed the defect. The procedures were conducted at Royal Brompton Hospital in London, England.
Commenting on the successful PFO closures using the SuperStitch EL Dr. Mullen stated, "The goal of PFO closure remains to achieve effective closure with minimal anatomical and biological impact. These cases confirm the potential for effective PFO closure without the disadvantages of synthetic devices. Based on our experience to date I believe we now have a reliable technique that will be applicable to a wide spectrum of PFO patients."
Anthony Nobles, PhD, Sutura's President and COO, commented, "Dr. Mullen's technique was excellent. These patients are the first two in a 50 patient PFO registry that will be have the SuperStitch EL used in their closure procedures at Royal Brompton and four other centers in the U.S. and Europe. We have now transitioned from development to design freeze and product launch. Our goal is to collect the registry data over the next few months and begin broader distribution in the fall."
Brian Abraham, PhD, CEO of Sutura added, "We are excited by the recent acceleration in progress we have made in finalizing the design and successfully deploying the product. We have a clearly outlined, executable strategy and are appreciative to our team, both internally and collaboratively, for executing this strategy according to plan."
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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