DSMB completes review of patient enrollment data in ZOLL Medical's CIRC trial

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.

“As the economy improves we look for the growth of the AutoPulse to accelerate.”

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.