ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced that a study demonstrating a reduction in total mortality after cardiac revascularization in patients prescribed a LifeVest® Wearable Defibrillator was presented at the American Heart Association’s Scientific Sessions 2011 in Orlando today.
Edwin Zishiri, M.D., Cleveland Clinic, presented an abstract entitled “Use of the Wearable Cardioverter Defibrillator and Survival after Coronary Artery Revascularization in Patients with Left Ventricular Dysfunction.” The analysis sought to determine if there is a difference in survival of patients with a left ventricular ejection fraction less than or equal to 35 percent (LVEF≤35%) using the LifeVest following surgical or percutaneous revascularization (CABG or PCI, respectively) compared to patients discharged without the LifeVest. Kaplan-Meier survival, Cox proportional hazards and propensity score matched analyses were performed to determine if survival differed in patients discharged after CABG or PCI revascularization with LVEF≤35% from a national database of LifeVest patients (N=809) compared to non LifeVest patients from registries at the Cleveland Clinic (N=4,149).
Survival curves showed an 80% reduction in total mortality at 90 days for LifeVest patients as compared to non LifeVest patients post PCI, with 90 day mortality of 2% for LifeVest patients versus 10% for non-LifeVest patients. In addition, LifeVest use was associated with an adjusted 57% lower risk of death in post PCI patients (p<0.0001) over a mean follow up of 3.1±2.3 years. Survival curves showed a 57% reduction in total mortality at 90 days for LifeVest patients as compared to non LifeVest patients post CABG, with 90 day mortality of 3% for LifeVest patients versus 7% for non LifeVest patients. In addition, LifeVest use was associated with an adjusted 38% lower risk of death in post CABG patients (p=0.048) over a mean follow up of 3.2 ± 2.5 years. In summary, LifeVest patients experienced a reduction in total mortality at both 90 days and 3 years as compared to the non LifeVest patients after cardiac revascularization.
“Patients with a low ejection fraction after a PCI or CABG have a high risk of mortality in the first 90 days following the procedure, with up to 60 percent of this mortality due to sudden cardiac death,” said Richard A. Packer, Chief Executive Officer of ZOLL. “These powerful data demonstrate that the LifeVest significantly reduces total mortality in these high risk patients during recovery following a revascularization. It is equally, if not more, remarkable that these data show the LifeVest reduces three year mortality, with continuing separation of the survival curves over the long-term. LifeVest is commonly worn by patients for 90 days following a PCI or CABG, and the fact that the mortality benefit of LifeVest extended beyond the time patients typically wear the device may indicate potential clinical benefits related to optimization of medical therapy, patient compliance with prescribed treatment and follow-up, along with other broad healthcare impacts.”
The LifeVest is worn by patients at risk for sudden cardiac arrest (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 a patient’s heart and, if a life-threatening heart rhythm is detected, the device delivers a treatment shock to restore normal heart rhythm.
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.
About ZOLL Medical Corporation
ZOLL Medical Corporation (zoll.com) develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and critical care.
A NASDAQ Global Select company and a Forbes 100 Most Trustworthy Company in 2007, 2008, and 2009, ZOLL was designated in 2011 as one of Forbes Top 100 Small Public Companies in America with annual revenues under $1 billion. ZOLL develops and manufactures its products in the United States, in California, Colorado, Illinois, Massachusetts, Pennsylvania, and Rhode Island. More than 400 direct sales and service representatives, 1,100 business partners, and 200 independent representatives serve our customers in over 140 countries around the globe.
Certain statements contained in this press release, including statements regarding the anticipated development of the Company's business, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Annual Report on Form 10-K filed with the SEC on December 17, 2010 and updated in the Company’s Quarterly Reports on Form 10-Q filed subsequently to the Form 10-K, including the Form 10-Q Quarterly Report filed on August 8, 2011. You should not place undue reliance on the forward-looking statements in this press release, and the Company disavows any obligation to update or supplement those statements in the event of any changes in the facts, circumstances, or expectations that underlie those statements.
Copyright © 2011 ZOLL Medical Corporation. All rights reserved. LifeVest and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All product names are the property of their respective owners.
A. Ernest Whiton, Chief Financial Officer ZOLL Medical Corporation
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