ZOLL LL Receives FDA Approval To Market New LifeVest Model

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Heart Disease
Article Date: 25 Aug 2009 - 18:00 PDT

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ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of resuscitation devices and related software solutions, has received approval from the U.S. Food and Drug Administration (FDA) to market and sell a new model of the LifeVest® wearable defibrillator.

The LifeVest wearable defibrillator is worn by patients at risk for sudden cardiac arrest (SCA), allowing their physicians time to assess their long-term arrhythmic risk and make appropriate plans, including potentially the decision to implant a cardioverter defibrillator (ICD). 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. Today over 2,000 patients are currently wearing the LifeVest.

"With the FDA approval of this additional LifeVest model, we are increasing inventory levels to provide improved customer service to support our continued growth," said Richard A. Packer, Chairman and Chief Executive Officer of ZOLL. "The flexibility to grow inventory in response to business needs positions us well to execute our aggressive field force expansion to reach our goal of 86 representatives in the U.S. by fiscal year-end." Mr. Packer went on to say, "We are pleased to be able to focus on meeting physicians' needs for this lifesaving therapy for their patients."

The LifeVest is rented to patients like other durable medical equipment (DME), allowing physicians to provide the patient the protection of the LifeVest by placing a medical order directly with ZOLL. From this point, ZOLL manages the process to protect the patient from sudden cardiac arrest from hospital discharge to recovery at home, including fitting the LifeVest to the patient, educating the patient in the hospital prior to release, managing all of medical documentation and insurance paperwork, and addressing via telephone and in person any patient needs once home.

Source
ZOLL Medical Corporation

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