Zoll Medical Corporation (NasdaqGS: ZOLL), a manufacturer of
resuscitation devices and related software solutions, announced today
that the first planned review of data related to patient enrollment in
the CIRC (Circulation Improving Resuscitation Care) Trial by the trial
Data Safety Monitoring Board (DSMB) has been completed and the trial is
proceeding with patient enrollment as originally designed.
Data from the international trial that is testing the effectiveness of
the FDA-cleared AutoPulse® Non-invasive Cardiac Support Pump,
in comparison to manual chest compressions alone, was fully reviewed by
the Data Safety Monitoring Board. The Board, which consists of several
physicians and a statistician, is responsible for ensuring the trial is
proceeding safely and in accordance with protocols, and has the
authority to halt the trial. If the Data Safety Monitoring Board were to
have any concerns about the safety of the trial, the Board would be
required to take action to insure patient safety and/or protocol
adherence. More than 700 cases from the two arms of the trial were
reviewed.
The principal investigator for the trial is Lars Wik, M.D., Ulleval
University, Oslo, Norway. Dr. Wik and colleagues from Houston, Texas;
Fox Valley Region, Wisconsin; Hillsborough County, Florida; Vienna,
Austria; and Nijmegen, The Netherlands, are conducting the research into
whether the AutoPulse-integrated chest compressions are superior or
equivalent to manual compressions alone for patients suffering cardiac
arrests tied to heart conditions. Each site has gone through extensive
training around very strict protocols established for the trial,
including proper use of the AutoPulse.
"We are pleased with the significant progress the CIRC Trial is making.
We note that an earlier trial of the AutoPulse, ‘ASPIRE’, was halted
prematurely after its first review due to futility and concerns about
safety, and if similar issues had been identified with CIRC, the DSMB
would have halted enrollment,” said Richard A. Packer, Chairman and
Chief Executive Officer of ZOLL. "Instead, we got a clean check-up and
are continuing ahead in this important effort.”
"While some clinicians are waiting for the results of this trial to
validate the contribution mechanical CPR can make to improving outcomes
from sudden cardiac death, recent reports presented at the American
Heart Association Resuscitation Science Symposium add to the continuing
science supporting the AutoPulse. A presentation from St. Charles
County, Missouri showed a marked likelihood of return of spontaneous
circulation in cardiac arrest patients treated with AutoPulse, and data
from a Statewide California Registry showed the risk of adverse events
associated with the AutoPulse to be no greater than with manual CPR
while improving return of spontaneous circulation by forty-five
percent,” Mr. Packer added. "As the economy improves we look for the
growth of the AutoPulse to accelerate.”
The AutoPulse has been commercially available for over four years and is
in use worldwide. It is manufactured by ZOLL Medical Corporation, which
is the CIRC trial's sponsor.
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
for the past three years, 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 Annual
Report on Form 10-K filed with
the SEC on December 10, 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.
Copyright © 2009 ZOLL Medical Corporation. All rights reserved. 269 Mill
Road, Chelmsford, MA 01824-4105. ZOLL and AutoPulse are registered
trademarks of ZOLL Medical Corporation. All product names are the
property of their respective owners.