MINNEAPOLIS--()--AGA Medical Holdings, Inc. (AGA Medical) (Nasdaq: AGAM) today announced first patient enrollment in the feasibility phase of the prospective, multicenter, randomized AMPLATZER® Cardiac Plug clinical trial. Dr. William Nicholson, an interventional cardiologist and structural heart specialist at York Hospital in Pennsylvania, enrolled the first patient.
“With our first patient enrolled, we are advancing a study that demonstrates our continued commitment to developing high-value products that can change the standard of care for patients, as well as providing physicians with scientifically sound data”
Scientific data have demonstrated that atrial fibrillation (AF) patients are five times more likely to suffer a stroke without treatment than those who do not have the heart arrhythmia. These strokes are linked to the left atrial appendage – a small structure off the left atrium of the heart – where blood can pool. The current standard of care is to treat these patients with anticoagulants (warfarin), which are difficult to tolerate for many people and carry a risk of serious complications, such as bleeding. This clinical study is evaluating the safety and efficacy of the AMPLATZER Cardiac Plug to close the left atrial appendage and prevent stroke in AF patients compared to warfarin, the most-prescribed, blood-thinning medication.
“Many patients struggle with the effects and regimen of warfarin, and I am hopeful that AF patients may have an alternative with the AMPLATZER Cardiac Plug to prevent stroke,” said Dr. Nicholson. “The AMPLATZER Cardiac Plug represents the next-generation of left atrial appendage closure devices, with a novel design that leverages the proven and easy-to-use AMPLATZER technology.”
An estimated 2.3 million Americans have AF, and the likelihood of developing it increases with age. In the United States, 3 to 5 percent of people over the age of 65 have the arrhythmia. AF can cause blood to pool in the left atrial appendage, increasing the chance of clots that may travel to the brain and lead to stroke.
President and chief executive officer of AGA Medical John Barr commented, “Beginning enrollment in this study is a significant milestone for AGA Medical. We believe that our device to close the left atrial appendage is an innovative solution to a complex and debilitating problem for patients and the health care system.”
“With our first patient enrolled, we are advancing a study that demonstrates our continued commitment to developing high-value products that can change the standard of care for patients, as well as providing physicians with scientifically sound data,” Barr continued.
The AMPLATZER Cardiac Plug received European CE Mark approval in December 2008, and is currently sold in Europe, South America and parts of the Pacific Rim.
About AGA Medical
AGA Medical, based in Plymouth, Minnesota, is a leading innovator and manufacturer of medical devices for the treatment of structural heart defects and vascular abnormalities. AGA Medical’s AMPLATZER® occlusion devices offer minimally invasive, transcatheter treatments that have been clinically shown to be safe and highly effective in defect closure. AGA Medical is the only manufacturer with occlusion devices approved to close seven different structural heart defects, with leading market positions for each of its devices. More than 1,650 articles supporting the benefits of AMPLATZER products have been published in medical literature. AGA Medical markets its AMPLATZER products in 112 countries worldwide to interventional cardiologists, electrophysiologists, interventional radiologists and vascular surgeons. More information about the company and its products can be found at http://www.amplatzer.com.
This news release may include “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, including, in particular, statements regarding the impact of approval of the study, initiation and timing of clinical trials, the possible outcomes obtained and the impact of such outcomes on patients, as well as our operating results. These statements are based on the beliefs of our management as well as assumptions made by, and information currently available to, the company. These statements reflect the company's current views with respect to future events, are not guarantees of future performance and involve risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. These factors include, among other things: failure to complete the company’s clinical trials or failure to achieve the desired results in our clinical trials; failure to implement the company’s business or commercialization strategy; failure to capitalize on the company’s expected market opportunities; lack of regulatory approval and market acceptance of the company’s new products, product enhancements or new applications for existing products; regulatory developments affecting the company’s products; and other risks and uncertainties, including those detailed in the company’s periodic reports filed with the Securities and Exchange Commission. You should not put undue reliance on any forward-looking statements. You should understand that many important factors, including those discussed herein, could cause the company’s results to differ materially from those expressed or suggested in any forward-looking statement. Except as required by law, the company does not undertake any obligation to update or revise these forward-looking statements to reflect new information or events or circumstances that occur after the date of this news release or to reflect the occurrence of unanticipated events or otherwise. Readers are advised to review the company's filings with the Securities and Exchange Commission (which are available from the SEC's EDGAR database at www.sec.gov, at various SEC reference facilities in the United States and via the company's Web site at www.amplatzer.com).