MedicalCV Announces Completion of a Series of U.S. Clinical Cases Using the ATRILAZE(TM) System for Cardiac Tissue Ablation
11 Abril 2005 - 11:35AM
PR Newswire (US)
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. (OTC:MDCV) (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 Phone 212.495.0200, ext. 10 / 17
http://www.medcvinc.com/ / http://www.roiny.com/ DATASOURCE:
MedicalCV, Inc. CONTACT: Christopher C. Hlozek, Vice President,
Marketing of MedicalCV, Inc., +1-651-452-3000, , or Investor
Relations, Robert Giordano, President, +1-212-495-0200, ext. 10, ,
or Sarah Shepard, Vice President, +1-212-495-0200, ext. 17, , both
of ROI Group Associates, Inc. Web site: http://www.medcvinc.com/
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