FDA approves wearable defibrillator for children
The FDA approved a new indication for the LifeVest wearable cardioverter defibrillator for children who are at risk for sudden cardiac arrest but are not candidates for an implantable defibrillator (due to certain medical conditions or a lack of parental consent). The LifeVest is manufactured by ZOLL Medical Corporation.
Although other automated external defibrillators that require a second person to operate have been cleared for use in children, LifeVest is the only one that is worn by the patient and monitors the heart continuously for abnormal, life-threatening heart rhythms. LifeVest responds automatically if it senses the need to deliver a shock to restore a life-sustaining heart rhythm.
Prior to this approval, the pediatric medical community was often forced to use adult devices off label, without appropriate labeling or instructions, in pediatric patients. LifeVest's pediatric approval was based on data from studies and a registry containing clinical information from 248 patients (ages 3 to 17) at risk for sudden cardiac arrest. No additional safety concerns were identified, and four patients who experienced sudden cardiac arrest received a shock that successfully restored a life-sustaining heart rhythm.
The LifeVest weighs less than 2 lb (1 kg) and consists of an electrode belt and garment that surrounds the chest and a monitor the patient wears around the waist. LifeVest is intended only for children who weigh at least 41 lb (18.6 kg) and have a chest size of 26 in (66 cm) or more-about the size of an average 8-year-old.
Insulin pump with integrated CGM approved for children
Animas Corporation has received FDA approval of the Animas Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes mellitus in children and adolescents, ages 2 to 17.
The Animas Vibe System is the first integrated system to feature Dexcom G4 Platinum CGM technology and is the only such system available in the United States for pediatric patients as young as 2. The Vibe System allows patients and their caregivers to view glucose data and administer insulin right from the pump, making it easy to fine-tune insulin delivery to help manage diabetes and monitor glucose trends accurately with one integrated device.
The Vibe System is the only CGM-enabled pump that is waterproof to 12 ft for up to 24 hours. The Dexcom G4 Platinum Sensor and Transmitter are water resistant up to 8 ft for 24 hours. Alerts can be customized to indicate high and low glucose levels, and a built-in, nonadjustable hypoglycemia safety alert is set at a glucose level of 55 mg/dL for extra peace of mind. The Dexcom Sensors are the only sensors approved for up to 7 days of wear. The system also has one of the smallest introducer needles available.
Humulin R U-500 KwikPen Prefilled Pen approved
The FDA approved Eli Lilly's insulin human injection (Humulin R U-500) KwikPen 500 units/mL, a prefilled device containing Humulin R U-500, a highly concentrated form of insulin. Humulin R U-500 is the only FDA-approved insulin that is five times more concentrated than standard U-100 insulin and is used to treat adult and pediatric patients with diabetes mellitus who need more than 200 units of insulin per day.
Until now Humulin R U-500 was available only in a vial, administered with either a U-100 insulin syringe or a volumetric syringe that requires conversion to respective syringe unit markings.
Although each U-500 KwikPen holds 1,500 units of insulin, it is the same size as other KwikPens and dials in 5-unit increments. The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens.
The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered via insulin infusion pump has not been determined.