MedicalCV, Inc. Announces Completion of 1st Closed-Chest, Beating Heart Cardiac Ablation with the SOLAR(TM) System.Ground-Breaking Technology Makes Least Invasive Surgical Ablation a Reality MINNEAPOLIS -- MedicalCV, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MCVI), www.medcvinc.com, announced today that J. Crayton Pruitt, M.D., one of the nation's leading pioneers in the minimally invasive surgical ("MIS") treatment of atrial fibrillation, completed the world's 1st closed-chest, beating heart cardiac ablation using the SOLAR[TM] Surgical Ablation System. Dr. Pruitt, a member of MedicalCV's Scientific Advisory Board, performed the procedure yesterday at Morton Plant Hospital Morton Plant Hospital is a 687 bed hospital at 300 Pinellas Street in Clearwater, Florida. Morton Plant is community-based and provides services in more than fifty specialty areas. This hospital is part of the greater BayCare Health System. in Clearwater, Florida. "I am excited to be the first surgeon to use the SOLAR[TM] System in a truly endoscopic approach," said Dr. Pruitt, a cardiothoracic surgeon at Cardiac Surgical Associates in Florida. "After completing the pulmonary vein isolation, I was especially pleased that I was able to demonstrate exit block which has been somewhat elusive with other technologies in the past." Marc P. Flores Flores, town, Guatemala Flores (flōrəs), town (1990 est. pop. 2,200), capital of Petén department, N Guatemala. Flores was built on an island in the southern part of Lake Petén Itzá and on the site of the , President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of MedicalCV stated, "This procedure represents the culmination of 36 months of focused customer interaction and intense product development to enable a true, minimally invasive surgical ablation. Coupled with the 15 ablations already performed with Intuitive Surgical's da Vinci Robot, we believe this latest procedure establishes MedicalCV as a leading player in the rapidly evolving MIS ablation market." Flores added, "We are grateful to Dr. Pruitt and his team at Morton Plant Hospital for helping us to reach this important milestone." The SOLAR[TM] System received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance for the ablation or coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or of soft tissue in March 2007. This builds on previous
clearances for the company's ATRILAZE[TM] System for the delivery
of laser light to soft tissue, including cardiac tissue, during surgical
procedures. However, the treatment of cardiac arrhythmias is
specifically excluded for both ablation systems. To date, the
company's laser-based technologies have been used in numerous
institutions around the country including Baylor University Medical
Center Baylor University Medical Center (BUMC) is located at 3500 Gaston Avenue in east Dallas, Texas (USA). Its medical services are often listed in the annual U.S. News & World Report compilation of Best Hospitals. , University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. Medical Center, Chicago's
Northwestern Memorial Hospital
San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. , as well as Scottsdale Healthcare - Osborn and Banner Baywood Heart Hospital in Arizona. 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[TM] and ATRILAZE[TM] Surgical Ablation Systems for use in soft and cardiac tissue ablation procedures, respectively; however, neither has been cleared for use in the treatment for cardiac arrhythmias. Both the SOLAR[TM] and ATRILAZE[TM] Systems have been utilized in concomitant open-heart and, by some cardiothoracic surgeons, in minimally invasive cardiac surgery minimally invasive cardiac surgery Interventional cardiology Any of a number of techniques–MIDCAB, off-pump coronary-artery bypass, minimally invasive valve surgery, port-access coronary surgery, and port-access valve surgery–increasingly being used to procedures. The Company's common stock is traded on the OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. under the symbol "MCVI." This release contains certain forward-looking statements of expected future developments, as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The forward-looking statements in this release refer to expectations regarding the commercialization of the company's SOLAR[TM] and ATRILAZE[TM] 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; the Company's ability to acquire qualified capital equipment and to manufacture the disposable components of its products in sufficient quantities to support initial clinical sites; competing technological and market developments; physician acceptance of the Company's products; dependence upon reimbursements and third party payors; the possibility that current clearances on the Company's products may not be sufficient to encourage widespread usage; 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. |
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