A medical device company that previously secured approval for a wearable adult defibrillator has won 510(k) clearance from the U.S. Food and Drug Administration for a pediatric version, according to a statement from the regulator.
ZOLL Medical Corp‘s LifeVest is approved for children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent, the FDA statement said.
The company claims that its device stands apart from automated external defibrillators that require a second person to operate them because it is only worn by the patient and provides continuous monitoring of the heart for abnormal, life-threatening arrhythmias.
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Medical device manufacturers don’t frequently develop indications for children and if they do, it can take years. The pediatrics market doesn’t represent a large enough market to be commercially viable to medical device manufacturers and their devices often have to be adjusted for younger, smaller users. To complicate matters, the patient recruitment process can be tricky.
These are the kinds of circumstances that propelled the development of the FDA’s pediatric medical device consortia. Children’s hospital clinicians collaborate with medical device companies to identify priorities for pediatric patients and work towards designing devices to fit those needs. ZOLL initially got FDA clearance for the first version of the device in 2001 and it subsequently got a greenlight for additional indications in 2002, 2006 and 2009. The market for this kind of device for children is small. Ventricular fibrillation is rare in children. It clearly sees a viable opportunity for pediatric applications , albeit one that has taken a backseat to the adult market.
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