MedicalCV, Inc. Announces Completion of First Clinical Cases with the SOLAR(TM) Surgical Ablation System.MINNEAPOLIS -- MedicalCV, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : MCVI MCVI Michigan Cardiovascular Institute (Bay City, Michigan) MCVI Miami Cardiac and Vascular Institute ), www.medcvinc.com, announced today that the SOLAR[TM] Surgical Ablation System, cleared for use in 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, has been used
successfully in its first clinical procedures. The first ablation
procedure was performed in conjunction with an open-heart mitral valve
repair Mitral valve repair is a cardiac surgery procedure performed by cardiac surgeons to treat stenosis (narrowing) or regurgitation (leakage) of the mitral valve. The mitral valve is the "inflow valve" for the left side of the heart. by Dr. Patrick M. McCarthy at Northwestern Memorial Hospital
"The device was easy to position and easy to deploy due to its automation features," said Dr. McCarthy, Northwestern Memorial's chief of cardio-thoracic surgery who is also co-director of the hospital's Bluhm Cardiovascular Institute and is a Heller-Sacks professor of surgery at Northwestern University's Feinberg School of Medicine The Feinberg School of Medicine is one of Northwestern University's 11 schools and colleges. It is a prestigious American medical school located in the Streeterville neighborhood of Chicago, Illinois, situated near Lake Michigan and the Magnificent Mile. . "We were able to reduce the amount of time the patient spent on cardiopulmonary bypass, which is good. I am very encouraged by these preliminary results." Dr. Caskey, a pioneer 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 , said, "MedicalCV's Ablation Systems proved to be uniquely suited for my application as they enabled me to utilize a right-sided, beating heart, minimally invasive technique to perform both an automated circumferential pulmonary vein isolation and additional lesion sets. Visually, I was able to verify that the lesion sets were transmural transmural /trans·mu·ral/ (trans-mu´ral) through the wall of an organ; extending through or affecting the entire thickness of the wall of an organ or cavity. trans·mu·ral adj. , or full-thickness, and was pleased that the patient left the operating room in normal sinus rhythm." "We are honored that pioneers like Dr. McCarthy and Dr. Caskey were the first surgeons in the country to utilize our SOLAR[TM] Ablation System," said 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. "These procedures represent another significant milestone for MedicalCV and illustrate the value of developing our laser-based technology platform through ongoing collaboration between leadings physicians from both the academic and community settings and our engineering team." In addition to being utilized in its first clinical procedures, the SOLAR[TM] Surgical Ablation System was recently highlighted in presentations at both the Advanced Cardiac Techniques in Surgery ("ACTS") and the American Association for Thoracic Surgery ("AATS AATS American Association for Thoracic Surgery AATS Ames Airborne Tracking Sunphotometer AATS Alternate Aircraft Takeoff System AATS Anti Aircraft Target System AATS Aircrew/Aircraft Tasking System AATS Audit Action Tracking System ") meetings before nearly 1000 physicians held earlier this month. The SOLAR[TM] and ATRILAZE[TM] Surgical Ablation Systems are based on MedicalCV's laser-based technology platform which has been designed to deliver focused, coherent light energy for the purpose of creating deep, continuous lesions during surgical ablation procedures. The automated SOLAR[TM] System recently received 510(K) clearance from the 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. with an indication for the delivery of laser light to soft tissue during surgical procedures. The ATRILAZE[TM] System is indicated for the delivery of laser light to soft tissue, including cardiac tissue, during surgical procedures. Neither the SOLAR[TM] System nor the ATRILAZE[TM] System has been cleared for the treatment of cardiac arrhythmias. About MedicalCV, Inc. MedicalCV, Inc. is a medical device company that develops, manufactures and sells surgical ablation systems that utilize a laser energy technology platform to create precise lesions, or scars, in soft and cardiac tissue. The Company's core technologies are the SOLAR[TM] and ATRILAZE[TM] Surgical Ablation Systems for use in soft tissue ablation 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.OB." For the full prescribing and use information for the SOLAR[TM] Surgical Ablation System, please visit our website at http://www.medcvinc.com/html/productsSOLAR.html. 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 the Company's expectations regarding the development and commercialization of its SOLAR[TM] Surgical Ablation System. 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 acquire qualified capital equipment and to manufacture the disposable components of our System in sufficient quantities to support our initial clinical sites; our ability to generate appropriate clinical data to increase physician acceptance of our product versus competitive products for which they may have more data; current clearance on the SOLAR[TM] Surgical Ablation System may not be sufficient to encourage widespread usage of our product. For more detailed information about these risks and uncertainties, please review the Cautionary Statement set forth in the Company's Quarterly Report on Form 10-QSB, as filed with the Securities and Exchange Commission on March 15, 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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