ZOLL Medical Corporation, the manufacturer of the LifeVest® Wearable Defibrillator, announced today that North Carolina’s Division of Medical Assistance has established a coverage policy for wearable cardioverter defibrillators. The LifeVest® is a wearable cardioverter defibrillator (WCD) worn by patients at risk of sudden cardiac arrest (SCA).
The policy, effective November 1, 2011, states that a WCD is considered medically necessary and covered by North Carolina Medicaid for patients, both ischemic and non-ischemic, who are at risk for sudden cardiac death and are not suitable candidates for immediate implantable cardioverter defibrillator (ICD) implantation. This new policy is effectively identical to the current Medicare coverage policy, providing coverage for patients with a low ejection fraction early after an acute cardiac event (e.g., myocardial infarction, non-ischemic dilated cardiomyopathy, or other dilated cardiomyopathy) during ICD waiting periods, familiar or inherited conditions with high-risk of ventricular tachyarrhythmias, documented ventricular tachyarrhythmias, and when an ICD cannot be implanted or requires explantation (e.g., infection or other temporary medical conditions).
“We are pleased with the decision by North Carolina Medicaid to provide coverage for wearable defibrillator therapy, especially given these challenging financial times for state budgets. I believe the decision to initiate coverage, after their thorough review of all available research and literature, highlights that wearable defibrillator therapy delivers both the quality of patient care and the economic value that payers are seeking,” said Richard A. Packer, Chief Executive Officer of ZOLL. “As payers more closely evaluate coverage policies for therapies to protect patients from sudden cardiac death (SCD), including wearable defibrillators and implantable defibrillators, they see the wisdom of the current Medicare policy originally initiated in 2005. The recent determination by North Carolina Medicaid that wearable defibrillators are medically necessary to protect patients at risk of SCD during ICD waiting periods represents yet another affirmation of that policy, which enables physicians to cost effectively save more lives.”
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.
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.
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. For more information, visit zoll.com.
Certain statements contained in this press release, including statements regarding the anticipated development of the Company's business, our belief regarding growth in the capital equipment market, 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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