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CHELMSFORD, Mass. -- ZOLL Medical Corporation, 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). It allows patients to return to their activities of daily living, while having the peace of mind that they are protected from SCA. The monitor housing for the lightweight and easy to wear LifeVest, is made of Bayblend FR-110 by Bayer, a flame retardant PC/ABS copolymer.
"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." Today over 2,000 patients are currently wearing the LifeVest.
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.
About Bayblend FR-110
Bayer's Bayblend FR-110, is flame retardant PC/ABS copolymer with super-high melt flow and high impact strength even at low temperatures. It has V-O & 5V flammability ratings at UL and is based on a novel flame retardance technology which is free of chlorinated and brominated flame retardant additives.
About ZOLL Medical Corporation
ZOLL Medical Corporation is committed to developing technologies that help advance the practice of resuscitation and temperature control therapies for the treatment of critical care patients. With products for pacing, defibrillation, circulation, temperature management, and fluid resuscitation, ZOLL provides a comprehensive set of technologies, including Real CPR Help® and See-Thru CPR®, which help clinicians, EMS professionals, and lay rescuers resuscitate sudden cardiac arrest or trauma victims. ZOLL also designs and markets software that automates the documentation and management of both clinical and non-clinical information.
ZOLL markets and sells its products in more than 140 countries. The Company has direct operations, distributor networks, and business partners throughout the U.S., Canada, Latin America, Europe, the Middle East and Africa, Asia, and Australia. During 2008 ZOLL marked the 25th anniversary of the Company's resuscitation product development.
Forward looking statements
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 August 7, 2009. 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.
Source: ZOLL Medical Corporation
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