ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of
resuscitation devices and related software solutions, announced today
that over 12,000 patients at high risk of sudden cardiac arrest (SCA)
have been prescribed the ZOLL LifeVest® Wearable
Defibrillator by their physician since it was approved by the FDA in
2002. This represents over 2,000 years of cumulative patient time
wearing a LifeVest, and, in any given month, more than 1,000 patients
are being protected from sudden death wearing the LifeVest.
LifeVest, the first and only wearable defibrillator, has a 98% first
shock success rate for treating patients with SCA. In addition, no
bystander intervention is required. This unique, non-invasive technology
continuously monitors the patient’s heart and, if a life-threatening
heart rhythm is detected, the device alerts the patient prior to
delivering a shock. The device releases a conductive gel onto the
therapy electrodes to protect the skin, and then delivers a shock to
restore normal heart rhythm. The entire event, from detecting a
life-threatening arrhythmia to automatically delivering a defibrillation
shock, usually occurs in less than a minute. Timely defibrillation is
the single most important factor in saving a SCA victim’s life.
"We are extremely pleased to see accelerating acceptance for the
LifeVest among cardiologists,” said Richard A. Packer, Chairman and
Chief Executive Officer of ZOLL. "We saw revenue growth over 50 percent
this fiscal year for the LifeVest. The ever-increasing number of
physicians regularly prescribing LifeVest creates a strong potential for
it to become a standard of care sometime in the future.”
There are two main components to the LifeVest: a garment and a monitor.
The garment is worn under clothing and records arrhythmias, including
before and after treatment. If it detects a life-threatening rhythm, the
device alerts the patient to allow a conscious patient to prevent the
shock. If the patient is unconscious, the device delivers an electric
shock to attempt to restore normal rhythm. The lightweight monitor
weighs about 1.8 pounds and is worn around the waist or from a shoulder
strap, making it the only wearable external defibrillator available.
Patients wearing the LifeVest are encouraged to wear the device
continuously, excluding time when bathing or showering.
Additionally, patients can connect the LifeVest monitor to a telephone
modem, and transmit their heart monitoring data to the LifeVest Network,
where their physicians can review the data.
The LifeVest is specifically approved by Medicare and other insurers for
those at high risk of cardiac arrest. The LifeVest is considered a
treatment option for patients who have the following medical conditions:
-
Primary prevention (EF<36% and either MI or NICM) including:
- Immediately after MI (Coverage during the 40 day ICD waiting period)
- Before and immediately after CABG or PTCA (Coverage during the 90 day
ICD waiting period)
- Listed for cardiac transplant
- Recently diagnosed nonischemic cardiomyopathy (Coverage during the 3
to 9 month ICD waiting period)
- NYHA class IV heart failure
- Terminal disease with life expectancy of less than 1 year
-
VF and sustained VT (spontaneous or induced) if it occurs >48 hours
post MI
-
All ICD indications are covered
-
Any ICD explantation
The amount of coverage for each indication is determined by the
approving insurance company’s policy.
Over half of the Medicaid programs in the United States are now covering
the LifeVest and more are coming online each month. Since state Medicaid
plans represent large populations in every state, this marks a
significant step in the LifeVest evolution. Over 1,200 health plans,
both commercial and state plans, now approve reimbursements for the
LifeVest.
About Sudden Cardiac Arrest
There are more than 325,000 deaths each year from out-of-hospital
cardiac arrest in the U.S. Estimates say that more than half of these
deaths occur suddenly. Currently, only about 5 percent of victims
survive; 95 percent will die from SCA. SCA strikes without warning and
can kill its victims within minutes.
About ZOLL Medical Corporation
ZOLL Medical Corporation is committed to developing technologies that
help advance the practice of resuscitation. With products for pacing,
defibrillation, circulation, ventilation, and fluid resuscitation, ZOLL
provides a comprehensive set of technologies, including Real CPR Help®
and See-Thru CPR®, that 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. 2008 marks the 25th anniversary of
ZOLL’s resuscitation product development. 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 August 8,
2008.
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 © 2008 ZOLL Medical Corporation. All rights reserved. 269 Mill
Road, Chelmsford, MA 01824-4105. ZOLL, LifeVest, Real CPR Help, and
See-Thru CPR are registered trademarks of ZOLL Medical Corporation. All
product names are the property of their respective owners.