May 27, 2010 - Wearable Defibrillator Discussed at Heart Rhythm Scientific Sessions

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A. Ernest Whiton
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ZOLL Medical Corporation
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Diane Egan
ZOLL Medical Corporation
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degan@zoll.com

ZOLL LIFEVEST DISCUSSED IN NINE SCIENTIFIC PRESENTATIONS AND POSTERS AT HEART RHYTHM SOCIETY’S 31ST ANNUAL SCIENTIFIC SESSIONS   

May 27, 2010CHELMSFORD, MASS.– ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that the LifeVest® Wearable Defibrillator was discussed in nine scientific presentations and posters at the Heart Rhythm Society’s 31st Annual Scientific Sessions in Denver, Colorado last week. The LifeVest presentations given at this premier international meeting of cardiac arrhythmia professionals illustrate the role of the LifeVest as an emerging standard of care to protect patients during their changing medical condition, and until their permanent risk of sudden cardiac arrest (SCA) is established.

“The electrophysiology community works diligently and tirelessly to ensure that patients with impaired ejection fractions receive consultation on the treatment options regarding the risks of SCA,” stated Richard A. Packer, Chairman and Chief Executive Officer of ZOLL.  “The LifeVest has been a focus of almost 100 scientific publications and presentations over the last several years.  The scientific data presented at this year’s Heart Rhythm Society's Scientific Sessions represents a robust addition to that growing library of evidence and demonstrates the important clinical role the LifeVest plays in the continuum of care for these patients,” Mr. Packer added. 

General Sessions

In the scientific session entitled “Evaluation and Management of Patients at Risk of Sudden Death in the Waiting Periods,” presenters discussed the use of the wearable cardioverter defibrillators (WCD) as part of their respective presentations.  Jeffrey Goldberger, M.D., Northwestern Memorial Hospital, discussed the clinical use of WCD during his presentation on the “Management of Patients Early after Diagnosis of Nonischemic Cardiomyopathy.”  Dr. Goldberger explained that WCD use is frequent in the nonischemic cardiomyopathy (NICM) patient population because there is a potential for recovery and, if long-term SCA risk is determined, it is unclear at diagnosis which type of device will be appropriate. 

Stefan Hohnloser, M.D., J.W. Geothe University,Frankfurt, Germany, discussed WCD use as part of his presentation, “Management of Patients Early Post-MI.”  Dr. Hohnloser stated that the arrhythmia substrate evolves over the first several weeks following a myocardial infarction and recommended the course of action to be optimized medical therapy, especially in congestive heart failure patients, followed by ischemia testing with optimized revascularization, and possibly SCA protection with a WCD.   

Andrew Epstein, M.D., University of Pennsylvania, discussed ejection fraction improvement as one clinical consideration during the waiting periods in his presentation, “Reconciling Practice Guidelines and Reimbursement Guidelines.”  Dr. Epstein recalled the results of the HEART Trial, stating that 66 percent of patients experienced left-ventricular ejection fraction improvement at 90 days with a mean absolute improvement of 4.5 percent.  The WCD was discussed as an option to protect patients from SCA during optimization of medical therapy, and the benefits from commercial WCD use to date were discussed, including no bystander intervention required,  98 percent first treatment shock success, and 92 percent treatment shock event survival (conscious ER arrival or stayed at home). 

In the scientific session “Prevention of Sudden Cardiac Death: The Pro´s and Con´s of ICD Therapy,” Georg Schmidt, M.D., Munich University of Technology, discussed the need to manage patients at high risk for sudden cardiac death in the first 40 days after myocardial infarction as part of his presentation on the “Risk Stratification to Improve Patient Selection.” The WCD was noted as one treatment option.    

In the scientific session, “Under-Referral For Primary Prevention ICDs: Who, Where, and Why?”, Michael Mirro, M.D., Parkview Health System, Fort Wayne, Indiana, discussed the benefits of a WCD in ensuring SCA screening in his presentation on the “Role of the Cardiologist and Primary Care Physician in Referral For Primary Prevention ICDs: Should We Consider Performance Measurement With Routine Sudden Cardiac Death Screening?”.

John G. Chenarides, M.D., Allegheny General Hospital, Pittsburgh, discussed WCD use when ICD implantation surgery is delayed or deferred due to patient condition both in a presentation and abstract entitled “Wearable Defibrillator Use Prior to ICD Implantation or Evaluation”. Dr. Chenarides et al. concluded that a WCD effectively prevents ventricular tachycardia (VT) and ventricular fibrillation (VF) death while a patient awaits ICD implantation.  

Poster Sessions

Edwin Zishiri, M.D., Cleveland Clinic, presented a poster entitled Appropriateness of ICD Indications:  Insights from an Analysis of Mortality Rates in Patients Using a Wearable Cardioverter Defibrillator.” Dr. Zishiri et al. performed an analysis of mortality by type of ICD indication (indications with as compared to without ICD waiting periods). He concluded that the lower mortality supports the deferral of an ICD implantation after acute cardiac events and use of a WCD, while awaiting improvements in the patient’s cardiac function.

Nicole Bianco, Ph.D., ZOLL Medical Corporation, presented a poster entitled “Impact of Transthoracic Impedance on Wearable Cardioverter Defibrillator Effectiveness.” Dr. Bianco et al. concluded that low shock impedance observed with the self-gelling electrodes of the LifeVest translated into an exceptional first-shock success in unconscious patients with sustained ventricular tachyarrhythmias.

Roger G. Carrillo, M.D., University of Miami, presented a poster entitled “Wearable Defibrillator Use after ICD Explantation.”  Dr. Carrillo et al. analyzed 2060 patients who used a WCD following ICD explantation larger due to either pocket infection or ICD malfunction and concluded that it is reasonable to use a WCD following ICD explantation if immediate reimplantation is not feasible or desired.

Raul Mitrani, M.D., Memorial Regional Hospital, Hollywood, Florida, presented a poster entitled “Use of Automatic Wearable Defibrillator in an Uninsured Patient Population”.  Dr. Mitrani et al. concluded that the WCD was associated with a high adherence to practice guidelines with regard to optimization for ejection fraction improvement and appropriate ICD implantation.  

In addition, over 200 physicians and clinicians attended a presentation by Joshua Cooper, M.D., University of Pennsylvania, and Ranjit Suri, M.D., Lenox Hill Heart and Vascular Institute, entitled “The Role of the LifeVest Wearable Defibrillator in the Continuum of Care for Patients at Risk of SCA” at Rhythm Theater. Their discussion focused on the treatment options for patients during waiting periods for implantable defibrillators and when implantable defibrillator implantation is postponed or prohibited due to patient condition, including explantation due to infection.

About the LifeVest Wearable Defibrillator

The LifeVest Wearable Defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), providing protection during their changing medical condition and until their permanent risk of SCA is established.  The LifeVest allows a patient’s physician time to assess his/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. To date, the LifeVest has been prescribed to more than 25,000 patients.

For more information, go to www.zoll.com or call 1-800-543-3267. 

About ZOLL Medical Corporation

ZOLL Medical Corporation 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 which 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 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 www.zoll.com

Certain statements contained in this press release, including statements regarding the future business of the Company, 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 Quarterly  Report on Form 10-Q filed with the SEC on May 14, 2010. 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.

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