Physician Prescriptions for ZOLL LifeVest Top 50,000

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced that more than 50,000 patients at high risk of sudden cardiac arrest (SCA) have been prescribed the LifeVest® Wearable Defibrillator.

The LifeVest is worn by patients at risk for SCA, providing protection during their changing condition and while permanent SCA risk has not been established. The LifeVest allows a patient’s physician time to assess his or her long-term arrhythmic risk and make appropriate plans.

The LifeVest is lightweight and easy to wear, allowing patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. The LifeVest continuously monitors the patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.

“As an investigator in the original WEARIT/BIROAD clinical trial and the primary investigator for the WEARIT II registry, it is rewarding to see so many patients have benefited from this therapy. The LifeVest plays an important role in the continuum of care for patients at high risk from SCA”, stated Arthur J. Moss, M.D., University of Rochester Medical Center.

“LifeVest allows physicians to protect patients during their period of highest risk early after an acute cardiac event such as a myocardial infarction or newly diagnosed nonischemic cardiomyopathy, when other therapies are not appropriate due to the patient’s changing condition and the potential for cardiac recovery.” “The fact that over 50,000 patients have been prescribed the LifeVest by their physicians is a meaningful milestone, made even more rewarding by the fact that it was reached during Sudden Cardiac Arrest Awareness Month.

The powerful result of partnering with physicians to protect so many patients from SCA is that all of these patients benefit from the peace of mind provided by the protection and a patient’s life is being saved almost each and every day by a ZOLL LifeVest,” said Richard A. Packer, Chief Executive Officer of ZOLL. The LifeVest is used for a wide range of patient conditions or situations, including following a heart attack, before or after bypass surgery or stent placement, as well as for those with cardiomyopathy or congestive heart failure that places them at particular risk. The LifeVest is covered by most health plans in the United States, including commercial, state, and federal plans. October 27, 2011: AtriCure's Synergy Ablation System Receives a Recommendation from FDA Expert Advisors AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and systems for the exclusion of the left atrial appendage, announced that AtriCure's Synergy Ablation System received a vote of approval from the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA).

The panel recommended that the FDA approve the system for the treatment of atrial fibrillation (AF) during open-heart concomitant surgical procedures. This marks the first time FDA's expert panel has voted to recommend a surgical ablation system to treat AF. "We are very pleased with the panel's approval recommendation and we look forward to working interactively with the FDA to facilitate an AF approval for our Synergy Ablation System. An AF label will result in a comprehensive surgeon training program, which we believe will optimize patient care and improve outcomes for patients with AF undergoing open-heart surgery," said David J. Drachman, President and Chief Executive Officer.

"We would like to thank all of our partners who worked with us on the ABLATE trial, particularly the FDA, physicians and their patients. Additionally, I would like to recognize the efforts of the AtriCure team, who have worked tirelessly toward the successful achievement of this important milestone." The Synergy Ablation System includes AtriCure's Isolator Synergy clamps, a radiofrequency generator and related switchbox. It is currently cleared in the United States for cardiac tissue ablation during concomitant open-heart surgical procedures. The approval recommendation by the panel includes a post-approval study and a physician training program. The FDA is not required to follow the panel's recommendations.