Healthcare Industry News: ATRILAZE
News Release - December 4, 2007
MedicalCV, Inc. Announces SOLAR(TM) System Cases in Milwaukee
Leading Minimally Invasive Cardiac Surgeon Completes Ablations in 3 Area HospitalsMINNEAPOLIS--(HSMN NewsFeed)--MedicalCV, Inc. (OTCBB:MCVI ), www.medcvinc.com, announced today that three procedures utilizing MedicalCV’s SOLAR™ Surgical Ablation System have been performed in recent weeks by Husam H. Balkhy, MD, a leading minimally invasive cardiothoracic surgeon specializing in the surgical treatment of arrhythmias, and a recent addition to the company’s Scientific Advisory Board. The procedures were performed in three different hospitals in the Milwaukee, Wisconsin area.
“I have been truly impressed by the SOLAR™ Surgical Ablation System in terms of both its ease of use and procedural performance,” said Dr. Balkhy, who is the Chairman of the Department of Cardiac Surgery at the Wisconsin Heart Hospital and a pioneer in minimally invasive arrhythmia surgery. “In addition, I have been able to achieve exit block each time I have tested for it which gives me great confidence in the technology.”
"Surgeons continue to demonstrate the versatility of our laser-based technology platform by utilizing our ATRILAZE™ and SOLAR™ Systems in robotic procedures with Intuitive Surgical’s da Vinci System, thoracoscopic procedures using standard endoscopic instrumentation, and in standard, open-chest procedures,” said Marc P. Flores, President and CEO of MedicalCV. “In addition to enabling the completion of their desired lesion sets, surgeons have reported both intraoperative conversion to normal sinus rhythm and exit block, demonstrating early stage success of our technology.”
To date, cardiothoracic surgeons from 10 leading institutions have performed a total of 80 cardiac ablations using the ATRILAZE™ System, the SOLAR™ System, or a combination of the two, in open and closed-chest procedures. This includes 70 ablations that were performed concomitantly (in conjunction) with other open-chest cardiovascular procedures and 10 that were performed in stand-alone, minimally invasive, closed-chest settings.
The SOLAR™ System received FDA clearance for the ablation or coagulation of soft tissue in March 2007. This builds on previous clearances for the company’s ATRILAZE™ System for the delivery of laser light to soft tissue, including cardiac tissue, during surgical procedures. However, the products are not approved for the treatment of cardiac arrhythmias, which is specifically excluded for both ablation systems. To date, the company’s laser-based technologies have been used in institutions around the country including Baylor University Medical Center, University of Michigan Medical Center, Chicago’s Northwestern Memorial Hospital, Baptist Medical Center in San Antonio, Texas, Abbott Northwestern Heart Hospital in Minneapolis, Minnesota, Wisconsin Heart Hospital in Milwaukee, Wisconsin, Morton Plant Heart Hospital in Clearwater, Florida, as well as Arizona’s Scottsdale Shea Hospital, Banner Good Samaritan Medical Center and Banner Baywood Heart Hospital.
About MedicalCV, Inc.
MedicalCV, Inc. is a medical device company that develops, manufactures and sells innovative, laser-based surgical ablation systems to create precise, clinically relevant lesions, or scars, in both soft and cardiac tissue. The Company's core products are the SOLAR™ and ATRILAZE™ Surgical Ablation Systems for use in soft and cardiac tissue ablation procedures, respectively. Both the SOLAR™ and ATRILAZE™ Systems have been utilized in concomitant open-heart and, by some cardiothoracic surgeons, in minimally invasive cardiac surgery procedures. The Company's common stock is traded on the OTC Bulletin Board under the symbol "MCVI."
This release contains certain forward-looking statements of expected future developments, as defined in the Private Securities Litigation Reform Act of 1995. The forward-looking statements in this release refer to expectations regarding the commercialization of the company’s SOLAR™ and ATRILAZE™ Surgical Ablation Systems. These forward-looking statements reflect management's expectations and are based on currently available data; however, actual results are subject to future risks and uncertainties, which could materially affect actual performance. Risks and uncertainties that could affect such performance include, but are not limited to, the following: the Company's ability to obtain financing required to continue operations; the ability to gather acceptable clinical data in a timely manner to support regulatory clearances; the ability of the Company’s suppliers to provide it with suitable clinical product; competing technological and market developments; physician acceptance of the Company's products; dependence upon reimbursements and third party payors; and the strength of the market for ablation products. For more detailed information about these risks and uncertainties, please review the Cautionary Statement set forth in the Company's Annual Report on Form 10-KSB, as filed with the Securities and Exchange Commission on July 25, 2007.
These events and uncertainties are difficult or impossible to predict accurately and many are beyond the Company's control. The Company assumes no obligation to publicly release the results of any revisions that may be made to any forward-looking statements to reflect events or uncertainties after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
For further information on MedicalCV, Inc., please visit www.medcvinc.com.
Source: MedicalCV
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