By Brittany Levine
The Orange County Register
SAN CLEMENTE, Calif. — A San Clemente startup published a study this month in the New England Journal of Medicine highlighting a new medical device that aims to change the way cardiac arrest is treated.
Cameron Health Inc. makes a heart defibrillator that doesn’t have to be placed on the heart. Others currently in use do.
Defibrillators shock the heart and turn rapid beating, which may lead to an abrupt loss of heart function, back to normal. Cameron’s device is known in the medical world as an implantable cardioverter-defibrillator.
The study is significant for Cameron. It led to commercial approval of the device in Europe, and the company is seeking approval from the U.S. Food and Drug Administration, said Rich Sanders, Cameron’s vice president of marketing.
If it wins approval, the company will have a shot at the U.S. market for ICDs, which Bloomberg has reported is a $4.3 million industry.
Sudden cardiac arrest accounts for about 325,000 deaths a year in the United States, according to the Heart Rhythm Society, a professional industry group.
Defibrillators typically have cords, known as leads, that are threaded through veins and then placed in or on the heart, according to a Cameron news release. The wires have been known to cause complications, the release says. Cameron said its main goal was to reduce complications by creating a device that doesn’t use such leads.
Cameron’s device is placed under the skin like other ICDs. It has been placed in four different areas near the rib cage, while most other ICDs are placed in the chest.
Though current ICDs have been effective in treating sudden cardiac arrest, there is room for improvement, Dr. Gust Bardy, co-founder of Cameron Health and lead author of its study, said in a statement.
“The findings suggest that physicians now have an important new option to consider when evaluating patients for defibrillator therapy, and one that may reduce the barriers to adoption of this life-saving therapy,” said Bardy, who also works with the Seattle Institute for Cardiac Research.
According to the Journal, the study doesn’t show that Cameron’s device is superior to current ICDs, but does point out that the new device can detect conditions leading to cardiac arrest and help the heart resume normal rhythm.
Cameron says the study’s data comes from several short- and long-term trials involving about 200 patients, some of whom received temporary implants of Cameron’s device, while others got permanent implants.
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