Medicalcv (MM) (NASDAQ:MDCV)
Historical Stock Chart
From Jun 2019 to Jun 2024
![Click Here for more Medicalcv (MM) Charts. Click Here for more Medicalcv (MM) Charts.](/p.php?pid=staticchart&s=N%5EMDCV&p=8&t=15)
MedicalCV Announces Completion of First U.S. Clinical Case Using
AtriLaze(TM) Surgical Ablation System in Open-Heart Surgery
The Laser System Precisely Replicated Maze Lesions
MINNEAPOLIS, Jan. 24 /PRNewswire-FirstCall/ -- MedicalCV, Inc. (OTC:MDCV)
(BULLETIN BOARD: MDCV) , http://www.medcvinc.com/ , a cardiovascular surgery
device manufacturer, focusing on surgical needs surrounding atrial
fibrillation, announced today the completion of the first U.S. human clinical
case using the AtriLaze(TM) Surgical Ablation System. The diode laser system
allows the cardiovascular surgeon to deliver laser energy to atrial tissue
creating exact and complete lines of cardiac tissue ablation.
Dr. Carmelo Otero, Cardiothoracic and Vascular Surgeon, performed the first
U.S. clinical case at Christus Santa Rosa Hospital in San Antonio, Texas. The
53 year old, female patient presented with paroxysmal atrial fibrillation
(A-Fib), mitral and tricuspid valve and coronary artery disease. The
AtriLaze(TM) surgical ablation procedure was performed as a concomitant
procedure with mitral valve replacement and tricuspid valve repair. Use of the
AtriLaze(TM) system added a minimal amount of time to the overall surgical
procedure.
"The AtriLaze(TM) system performed well, allowing me to easily and precisely
replicate Maze lesions," said Dr. Otero. "The laser technology provides me the
capability to safely and quickly create an array of cardiac lesions that
enabled today's successful clinical case. The AtriLaze(TM) system facilitates a
simple, reproducible technique that I believe will be very effective in
concomitant cardiac surgical procedures and potentially lends itself to
minimally invasive and robotic surgical treatments of A-Fib," commented Dr.
Otero.
Marc P. Flores, President and Chief Executive Officer of MedicalCV, Inc.
commented, "We are pleased to enter the U.S. market with this innovative
technology for surgical cardiac tissue ablation. The atrial fibrillation
market is in a state of chaos looking for an 'ideal' technological solution to
provide a minimally invasive surgical option that mirrors outcomes of the 'gold
standard' surgical Maze procedure. This successful surgery represents a further
milestone in the Company's goal of providing a better treatment solution for
ablating cardiac tissue."
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 and is
focusing its resources on the minimally invasive treatment of A-Fib as a
stand-alone procedure.
"The laser's physical properties are a specific balance of absorption and
transmission through atrial tissue that optimizes overall photocoagulation,"
said Adam L. Berman, Vice President, Research and Development. "Through our
continued development efforts, we believe the delivery of light energy through
low-profile fiberoptic elements has the potential to enable closed-chest,
beating heart procedures for cardiac tissue ablation."
About MedicalCV, Inc.
MedicalCV, 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.
Historically, MedicalCV developed and marketed Omnicarbon(R) mechanical heart
valves and its proprietary pyrolytic carbon processes. The Company acknowledges
their continued maintenance of the mechanical heart valve business, supporting
their customers and distributors during the divestiture process. The Company
also continues to concentrate it resources on the A-Fib market. The Company's
securities are 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, efficaciousness and safety 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 the Form 8-K filed 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.
DATASOURCE: MedicalCV, Inc.
CONTACT: John H. Jungbauer, Vice President, Finance and CFO 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/