Healthcare Industry News: Mitral Valve
News Release - May 16, 2007
MedicalCV, Inc. Announces Completion of First Clinical Cases with the SOLAR(TM) Surgical Ablation SystemMINNEAPOLIS--(HSMN NewsFeed)--MedicalCV, Inc. (OTCBB: MCVI ), www.medcvinc.com, announced today that the SOLAR(TM) Surgical Ablation System, cleared for use in the ablation or coagulation 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 by Dr. Patrick M. McCarthy at Northwestern Memorial Hospital in Chicago, Illinois. The second ablation was performed in conjunction with a minimally invasive Mitral Valve repair by Dr. Michael P. Caskey in Phoenix, Arizona. Both Dr. McCarthy and Dr. Caskey serve on MedicalCV's Scientific Advisory Board.
"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. "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, 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, 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, President and CEO 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") 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 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 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 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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