MINNEAPOLIS, Mar 24, 2010 (BUSINESS WIRE) -- AGA Medical Holdings, Inc. (AGA Medical) /quotes/comstock/15*!agam/quotes/nls/agam (AGAM 14.86, +0.09, +0.61%) today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to evaluate the safety and efficacy of its AMPLATZER(R) Cardiac Plug, or ACP, to close the left atrial appendage. The trial is designed to demonstrate efficacy in preventing stroke in atrial fibrillation patients who are eligible to receive Warfarin, as well as safety of the device and the procedure.
President and Chief Executive Officer of AGA Medical John Barr commented, "Stroke can be a debilitating condition, and is a significant concern to the approximately 4.5 million people in the United States and Europe suffering from atrial fibrillation. Approval of this study will now allow us to further evaluate our approach to reducing strokes in patients with atrial fibrillation by using our AMPLATZER Cardiac Plug to permanently seal the appendage, hopefully sparing patients from spending the rest of their lives on anticoagulants."
The ACP clinical study will be a multicenter trial with a two-to-one randomization between the ACP and medical management, Warfarin, the current standard of care. The study design is based on a statistical method referred to as a Bayesian adaptive design with interim analyses that use observed efficacy and safety event rate data to predict the final sample size, probabilities for trial success and when the trial should be stopped. Interim analyses will be performed after the first 400 patients are enrolled and at pre-determined periodic intervals thereafter, until a possible maximum of 2,000 patients are enrolled. These interval analyses will determine when the trial has achieved its endpoints and if AGA Medical is able to conclude the trial prior to enrolling 2,000 patients.
This trial design will include a feasibility phase to be followed by a pivotal phase. The results of the feasibility phase, which consists of the first 30 patients to receive the ACP, will serve to further validate safety conclusions demonstrated through pre-clinical testing. These patients will be followed for 45 days after the procedure and evaluated for adverse events. The 45-day feasibility data will be reviewed by an independent data safety monitoring board prior to FDA review. Additional subjects will be enrolled in the pivotal phase of the trial after the FDA has completed its review.
Scientific data have demonstrated that patients with a heart arrhythmia, called atrial fibrillation, face a five-fold higher incidence of stroke. Clinical research has further demonstrated that a stroke in these patients is linked to a small structure, shaped like a pouch, off the left atrium of the heart called the LAA. Atrial fibrillation can cause blood to pool in the LAA, increasing the chance of clots that may travel to the brain and lead to stroke. The current standard of medical care is to treat these patients with anticoagulants, which are difficult to tolerate for many people and carry a risk of complications, such as bleeding.
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(R) 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 1,500 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.
Forward-Looking Statements
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).
