Defibtech gains FDA clearance to market pediatric defibrillation pads
The pediatric pads are specially designed to be used on children under age 8. The pads attach to the child's chest and deliver the AED's lifesaving defibrillation at an optimal energy level.
Defibtech has announced that it gained clearance from the Food and Drug Administration (FDA) to market pediatric defibrillation pads for its Lifeline(TM) and ReviveR(TM) automated external defibrillators (AEDs).
Defibtech's product enhancement will enable schools and community resources serving children to have pediatric pads for the best value AED in the market, said Defibtech CEO Glenn W. Laub. Many states have passed or introduced legislation that facilitates or mandates the placement of AEDs in schools. With a single-unit list price of $1,495, the Lifeline(TM) and ReviveR(TM) units are the most-affordable, fully featured AEDs available. The pediatric pads are available as an option at a list price of $99.
"Now, our AEDs can be equipped to save a young child's life," said Defibtech CEO Glenn W. Laub, M.D. "Our easy-to-use and effective devices make lifesavers out of ordinary people."
The pediatric pads are specially designed to be used on children under age 8. The pads attach to the child's chest and deliver the AED's lifesaving defibrillation at an optimal energy level. According to American Heart Association 2004 heart disease statistics, about 340,000 Americans lose their lives to sudden cardiac arrest (SCA) each year, and SCA accounts for 19 percent of sudden deaths among children age 1 to 13. With timely defibrillation, most victims of SCA survive; without it, fewer than 5 percent live. Among the causes of SCA in children are conditions such as ventricular fibrillation, commodio cordis, Long QT Syndrome and Wolff-Parkinson-White Syndrome.
"Our AEDs make safety more affordable and accessible," Dr. Laub said. "By purchasing AEDs with the lowest per-unit price on the market, our customers can buy more units for their money and provide lifesaving technology for adults and children at more locations."
The pediatric pads add capability to a unit already recognized for its innovative design and technology. The Defibtech AED received an Excellence in Design Award in the medical category from Appliance Manufacturer magazine. Easy to use, the Defibtech AED actually "talks" to the user, giving audible step-by-step instructions on how to give lifesaving defibrillation. The unit's bright yellow and black design makes it recognizable and easy to find quickly. Having the industry's longest operational battery life, the Defibtech AED is built to the durability standards of professional emergency personnel.
Defibtech relentlessly pursues one goal: making the best automatic external defibrillators (AEDs) in the world at affordable prices. Defibtech designs and manufactures the FDA-approved, Lifeline(TM) and ReviveR(TM) brand AEDs and related accessories. Defibtech's products are sold through its network of distribution partners in the United States and around the world. Founded in 1999, Defibtech is headquartered in Guilford, Conn., and manufactures all of its defibrillators in the United States in a state-of-the-art ISO-9002 certified facility. Defibtech also has earned the CE Marking and ISO-13485 certification. For more information about Defibtech and its products, visit www.defibtech.com or call (866) DEFIB-4-U (866-333-4248)