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Nika · #1 (**permalink**) 04-12-2005, 11:14 PM

Source:
PR Newswire

MedicalCV Announces Completion of a Series of U.S. Clinical Cases Using the ATRILAZE(TM) System for Cardiac Tissue Ablation

Two Months After Surgery All Patients Show Freedom from Atrial Fibrillation

MINNEAPOLIS, April 11 /PRNewswire-FirstCall/ -- MedicalCV, Inc. (BULLETIN BOARD: MDCV) , http://www.medcvinc.com/ , a cardiovascular surgery device manufacturer, focusing on the surgical needs surrounding atrial fibrillation, announced today the completion of a series of U.S. human clinical cases using the ATRILAZE(TM) Surgical Ablation System. The diode laser system allows the cardiovascular surgeon to deliver laser energy to create exact and complete lines of cardiac tissue ablation.

Dr. Baron L. Hamman, Cardiothoracic Surgeon, performed a series of U.S. clinical cases recently at Baylor University Medical Center in Dallas, Texas. The three patients presented with chronic atrial fibrillation (AF), mitral valve and coronary artery disease. The AtriLaze(TM) surgical ablation procedures were performed as concomitant procedures with mitral valve repair or replacement and coronary artery bypass grafting. The Company advised that the use of the AtriLaze(TM) system added less time when compared to the "standard" cut and sew Maze procedure.

"The AtriLaze(TM) system is a simple, intuitive tool that allows me to make rapid, precise Cox-Maze III partition lines," said Dr. Hamman. "The laser system employs an optimal light wavelength to deliver deep penetrating energy to atrial tissue that I found to be effective in this series of patients. Two months after surgery, each of the patients show freedom from atrial fibrillation," commented Dr. Hamman.

MedicalCV, Inc. acquired rights to the AtriLaze(TM) Surgical Ablation System in September 2003 and received FDA 510(k) clearance on November 30, 2004. The Company is currently marketing the AtriLaze(TM) system for clinical use in ablating cardiac tissue and is focusing its resources on the stand-alone, minimally invasive (closed-chest, beating heart) surgical treatment of AF.

"The completion of these series of clinical cases marks the beginning of an exciting move into the clinical setting providing surgeons and patients an alternative to the current technologies that are available for ablating cardiac tissue," said Christopher C. Hlozek, Vice President, Marketing of MedicalCV, Inc. "This initial methodical release of the AtriLaze(TM) system sets the foundation for our future clinical endeavors to provide a stand-alone, minimally invasive (closed-chest, beating heart) procedure for surgical cardiac tissue ablation and more importantly, defining the market of atrial fibrillation."

MedicalCV, Inc. will be at the 85th Annual Meeting of the American Association for Thoracic Surgery (AATS) this week at the Moscone West Convention Center in San Francisco, California. The executive team will be available to meet with cardiovascular surgeons and the media to answers questions and give updates on the Company's recent developments. To schedule a meeting, please contact Dez Raak at headquarters, phone (651) 452-3000.

About MedicalCV, Inc.

MedicalCV, Inc., a cardiovascular surgery device manufacturer, focuses on the design, development and commercialization of new, improved and enhanced technologies, products, methods and techniques to treat cardiovascular disorders and disease, including products targeting the treatment of atrial fibrillation ("AF"). Historically, MedicalCV developed and marketed Omnicarbon(R) mechanical heart valves utilizing its proprietary pyrolytic carbon processes. Although the Company ceased manufacturing new heart valves in September 2004, it had continued to maintain the mechanical heart valve business, supporting customers and distributors during the divestiture process. After April 30, 2005, the Company will discontinue sales of the Omnicarbon(R) heart valve. The Company is concentrating its resources on the AF market. The Company's core technology is the ATRILAZE(TM) Surgical Ablation System, for use in cardiac tissue ablation in surgery, which the Company acquired on August 27, 2003 and for which it received FDA 510(k) clearance on November 30, 2004. The Company's common stock is traded on the OTC Bulletin Board under the symbol "MDCV."

For further information on MedicalCV, Inc., please visit http://www.medcvinc.com/ .

You may register to receive MedicalCV's future press releases and to be added to the Company's distribution list by visiting: http://www.roiny.com/form.php .

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 our expectations regarding disposition of our heart valve business, operating improvements, development of atrial fibrillation product and 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 supplies; and the strength of the market for cardiovascular products. For more detailed information about these risks and uncertainties, please review the Company's Annual Report on Form 10- KSB for the fiscal year ended April 30, 2004 and our 8-K report filed with the Securities and Exchange Commission on January 6, 2005

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.

MedicalCV, Inc. Contact: Investor Relations Contact: Christopher C. Hlozek ROI Group Associates, Inc. Vice President, Marketing Robert Giordano / Sarah Shepard Phone 651.452.3000 President / Vice President chlozek@medcvinc.com Phone 212.495.0200, ext. 10 / 17 http://www.medcvinc.com/rgiordano@roiny.com / sshepard@roiny.com http://www.roiny.com/Source: MedicalCV, Inc.

CONTACT: Christopher C. Hlozek, Vice President, Marketing of MedicalCV,
Inc., +1-651-452-3000, chlozek@medcvinc.com , or Investor Relations, Robert
Giordano, President, +1-212-495-0200, ext. 10, rgiordano@roiny.com , or Sarah
Shepard, Vice President, +1-212-495-0200, ext. 17, sshepard@roiny.com , both
of ROI Group Associates, Inc.

Web site: http://www.medcvinc.com/