First Patient Successfully Treated with Innovative Procedure Focused on Most Challenging Atrial Fibrillation Patient Segment
NORFOLK, Va.--(BUSINESS WIRE)--Sep 17, 2012--Sentara Heart Hospital is leading the way in an innovative Atrial Fibrillation (AF) procedure for what is typically the most difficult to treat or persistent, forms of AF. This past week, surgeons and cardiologists at Sentara Heart Hospital were the first in the world to begin performing surgeries in the feasibility trial. The first procedure was performed by cardiothoracic surgeon collaborator Jonathan Philpott, M.D., director of the Sentara Atrial Fibrillation Surgery Program and cardiac electrophysiologist collaborator Ian Woollett, M.D. of Cardiovascular Associates.
The Staged DEEP trial is a Food and Drug Administration-approved pilot study sponsored by cardiac device manufacturer, AtriCure, Inc. The study is designed to evaluate the safety and efficacy of a combined procedure whereby the surgeon creates lines of block on the outside of the heart working through tiny chest incisions. During the same hospital stay, an electrophysiologist tests the surgical lines and then completes additional ablation lines using tiny catheters within the heart. There are currently no FDA approved devices for the Minimally Invasive Surgical (MIS) or endocardial treatment of persistent forms of AF and current options yield very limited success.
"We believe that this staged hybrid procedure has the potential to represent an important advancement in the treatment of persistent forms of AF," commented Robert Bernstein, M.D., a leading electrophysiologist in Norfolk VA, and one of four electrophysiologists at Sentara collaborating in the trial. "Our initial experience with this hybrid procedure suggests that it represents a highly promising AF treatment." AF is the most common irregular heartbeat affecting more than 2 million people in the United States. AF is characterized by heart palpitations, dizziness and shortness of breath. Persistent forms of AF comprise roughly half of the AF patient population. This number is expected to increase significantly due to the progressive nature of the disease and the aging population.
Dr. Philpott added, "Our preliminary experience with this procedure is very encouraging. The partnership between the electrophysiologist and the cardiac surgeon in the hybrid procedure leverages the skills and technologies of each specialist providing patients with the most comprehensive ablation and mapping procedure available.” Dr. Woollett added, “Staging these procedures gives the cardiac surgeon and the electrophysiologist the flexibility to work within their own familiar environments making each team more efficient and effective.” Sentara offers a number of services to help patients manage AF, including the Sentara Heart Arrhythmia Center – the region's first and only center that brings together highly talented cardiothoracic surgeons and cardiac electrophysiologists to diagnose and treat simple to complex AF and other cardiac arrhythmias.
Sentara Heart Hospital is one of only five leading AF Centers of Excellence participating in this FDA trial. Other medical centers included are Stanford Medical Center, Palo Alto, California, Vanderbilt Heart Institute, Nashville, Tennessee, University Hospital Brussels, Brussels, Belgium and the Academic Medical Center of the University of Amsterdam, Amsterdam, Netherlands.
To learn more about heart services at Sentara Heart Hospital, visit the cardiac care page on www.Sentara.com. For more health information and the latest press releases, visit the Sentara Healthcare News Page.AtriCure, Inc. (NASDAQ:ATRC), a medical device company, received final approval from the Food and Drug Administration to proceed with the DEEP AF trial June 27, 2012. AtriCure is the first and only medical device company with an FDA approval for the treatment of non-paroxysmal AF patients. This approval is for patients undergoing a concurrent structural heart disease procedure. For more information regarding AtriCure, visit www.AtriCure.com.
The Staged DEEP AF trial uses AtriCure's MIS ablation product platform in conjunction with the Biosense Webster® THERMOCOOL® catheter ablation products.
Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure’s products. Forward-looking statements are based on AtriCure’s experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure’s control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure’s products, AtriCure’s ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure’s products, competition from existing and new products and procedures or AtriCure’s ability to effectively react to other risks and uncertainties described from time to time in AtriCure’s SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
The FDA has not cleared or approved certain AtriCure products for the treatment of AF or a reduction in the risk of stroke. MKT-1640A-GCONTACT: AtriCure Media Contact: Pickett and Associates Patricia Pickett, 317-501-8275 firstname.lastname@example.org or Sentara Media Contact: Sentara Communications Department Kim Van Sickel, 757-984-8132 email@example.com KEYWORD: UNITED STATES NORTH AMERICA OHIO VIRGINIA INDUSTRY KEYWORD: SURGERY HEALTH CARDIOLOGY HOSPITALS MEDICAL DEVICES RESEARCH FDA SCIENCE SOURCE: AtriCure, Inc. and Sentara Healthcare Copyright Business Wire 2012 PUB: 09/17/2012 05:00 PM/DISC: 09/17/2012 05:00 PM http://www.businesswire.com/news/home/20120917006517/