MedicalCV Receives Third FDA 510(k) Clearance for Laser Technology; Company Advances Its Leadership Position in Laser Technology for a Stand-Alone, Closed-Chest, Minimally Invasive Solution for Treating Atrial Fibrillation.MINNEAPOLIS -- MedicalCV, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MDCV MdCV Marais des Cygnes Valley (Kansas) MDCV Maximum Dry Cargo Volume MDCV Merci Dieu C'est Vendredi (French: Thank God It's Friday) ), www.medcvinc.com, announced today that it has received its third 510(k) clearance from the U.S. Food and Drug Administration (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. ) which states that, "The MedicalCV Atrilaze(TM) Surgical Ablation system is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue during surgical procedures." This latest 510(k) clearance is for the 1064 nm wavelength laser technology, and complements its existing 810 nm wavelength laser technology, which has already received two FDA 510(k) clearances. This new clearance increases the functionality of the AtriLaze system allowing for further optimization and miniaturization min·i·a·tur·ize tr.v. min·i·a·tur·ized, min·i·a·tur·iz·ing, min·i·a·tur·iz·es To plan or make on a greatly reduced scale. min , two characteristics required for a true, minimally invasive approach for treating atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. . MedicalCV is a cardiovascular surgery cardiovascular surgery Heart surgery An operation for repairing structural defects of the cardiovascular system Examples CABG, repair of congenital heart defects, varicose veins, aortic aneurysms, ventricular remodeling, transmyocardial company focused on developing a truly minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an (closed chest, beating heart) for the treatment of atrial fibrillation by utilizing a platform of laser-based technology for cardiac tissue ablation in surgery. 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 commented, "This most recent and strategic FDA clearance has broadened our laser technology spectrum with the inclusion of a 1064 nm wavelength. With this wavelength, we are optimizing the application of laser energy to cardiac tissue. Furthermore, this wavelength is particularly suitable for the miniaturization required to utilize laser technology through smaller access ports, bringing us one significant step closer to delivering a truly stand-alone, minimally invasive procedure for the treatment of atrial fibrillation." Flores concluded, "We believe our laser-based technology platform and forthcoming minimally invasive solution will allow for the widespread adoption of a consistent and effective stand-alone procedure for the treatment of atrial fibrillation." About MedicalCV, Inc. MedicalCV, Inc., a cardiovascular surgery company, focuses on the development and introduction of products designed to improve patient outcomes through the early treatment of cardiovascular disorders and disease, specifically products used by cardiac surgeons to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise cardiac tissue as a potential means to treat atrial fibrillation. The Company's core technology is the AtriLaze(TM) Surgical Ablation System for use in cardiac tissue ablation procedures. With the use of its platform of laser-based technology, the Company is focused on developing a truly minimally invasive procedure (closed chest, beating heart) for the treatment of atrial fibrillation. 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 "MDCV." For further information on MedicalCV, Inc., please visit www.medcvinc.com. 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 our expectations regarding our development and commercialization of products for the minimally invasive treatment of atrial fibrillation. 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 fund significant capital needs; market acceptance in the U.S. of the Company's cardiovascular products; acceptance of minimally invasive techniques for the reduction of atrial fibrillation through ablation; potential reductions in pricing by competitors; the costs of licensing and acquiring new products and technologies; the time and costs involved in obtaining regulatory clearance for cardiovascular products; competing technological and market developments; physician acceptance of the Company's cardiovascular products; dependence upon governmental reimbursements and third party suppliers; and the strength of the market for cardiovascular products. For more detailed information about these risks and uncertainties, please review the Company's Current Report on Form 8-K, as filed with the Securities and Exchange Commission on March 29, 2006. 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. |
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