Cardiac Science Shares Rise 44% After FDA Clears New Device

Cardiac Science Inc. stock climbed 44% Thursday after the Irvine company said it has received clearance from the Food and Drug Administration to market its combination heart monitor and defibrillator.

The shares, which trade over the counter, rose $1 to $3.25.

The bedside detection and defibrillation device, to be marketed under the brand name Powerheart, is designed to prevent the damage caused by undetected heart attacks in hospital patients. The device can detect a dangerous change in the heart’s rhythm and shock the heart back to normal within seconds.

“Recognition is the issue,” said Raymond Cohen, president and chief executive officer for Cardiac Science. “Access to defibrillation is not the problem. Defibrillation is available once cardiac arrest is observed.”

Defibrillators use an electrical pulse to “jump-start” the heart and are extremely effective when used immediately following a heart attack.

In most hospital settings, however, there is a significant delay between the time a patient’s heart stops beating and the time the attack is registered and treated. Only about 15% of the patients survive in-hospital heart attacks, and that rate has remained largely unchanged since the 1960s, Cardiac Science said.

In clinical trials, the device showed a 100% accuracy rate in identifying when a patient needed to be shocked, and a response time of 21 seconds, the company said.