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Published on 6/13/2006 in the Prospect News Biotech Daily.

ZOLL Medical says mixed results of AutoPulse in two published studies 'unexpected'

By Lisa Kerner

Charlotte, N.C., June 13 - ZOLL Medical Corp. commented on the publication in The Journal of the American Medical Association of the Aspire Trial and the Richmond Study, both of which relate to the AutoPulse Non-invasive Cardiac Support Pump.

"The unexpected Aspire Trial results coupled with the strong positive Richmond Study results continue to confound many clinicians in the resuscitation industry," president and chief executive officer Richard A. Packer said in a company news release.

"We maintain our belief that the AutoPulse has great potential for improving CPR performance in out-of-hospital and in-hospital settings. The favorable findings of the Richmond Study and five other previous studies create a strong body of evidence that supports the device."

The Aspire Trial article entitled "Manual Chest Compression vs. Use of an Automated Chest Compression Device During Resuscitation Following Out-of-Hospital Cardiac Arrest" reported on interim data in which survival at four hours was similar between 394 patients who received the AutoPulse (24.7%) and 373 patients who received manual CPR (26.4%).

Survival to hospital discharge was lower in patients who received AutoPulse (5.8%) compared to those who received manual CPR (9.9%). The trial was halted based on this data.

In the Richmond Study article entitled "Use of an Automated, Load-Distributing Band (LDB) Chest Compression Device for Out-of-Hospital Cardiac Arrest Resuscitation," the use of the AutoPulse was compared to manual CPR efforts prior to implementing the AutoPulse.

The improvement in the return of spontaneous circulation was 34.5% for the AutoPulse and 20.2% for manual CPR. There was a statistically significant improvement in survival to hospital admission with the AutoPulse (20.9%) versus manual CPR (11.1%).

The AutoPulse improvement in survival to hospital discharge was more than double that of manual CPR.

Based in Chelmsford, Mass., ZOLL develops technologies that help advance the practice of resuscitation, including products for pacing, defibrillation, circulation, ventilation and fluid resuscitation.


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