In a groundbreaking advance for pediatric cardiac care, the U.S. Food and Drug Administration (FDA) recently approved the OmniaSecure™ lead — the world’s smallest implantable defibrillator (ICD) lead and the first ever granted FDA approval for use in children ages 12 and older. Children’s Hospital of Philadelphia (CHOP) was the only pediatric institution selected to participate in the pivotal clinical trial that supported this approval.
Medical Director of CHOP’s Electrophysiology and Heart Rhythm Program, Maully Shah, MBBS, FACC, FHRS, CCDS, CEPS, served as the sole pediatric investigator on the study’s steering committee. Dr. Shah and CHOP attending cardiologist Chandra Srinivasan, MD, FHRS, CCDS, CEPS, were the only trained pediatric implanters of the new device in the country. “The industry has a lot of confidence in the excellence of care that we provide to our patients at CHOP,” says Dr. Shah. “As a well-known and well-resourced institution, they knew we would have the bandwidth to participate in the trial. Prior to this, the cardiac rhythm management device industry has never worked with a pediatric institution or a pediatric electrophysiologist on the study team pre-FDA approval.”
Implantable defibrillators are devices used to help prevent sudden cardiac death by correcting dangerous heart rhythms. They work by connecting to the heart through a thin, insulated wire called a lead. The lead senses the heart’s rhythm and sends that information to the device. If the heartbeat becomes dangerously fast or irregular, the device sends a signal back through the lead to correct it.
Historically, children have been left out of FDA trials for electrophysiology devices these like. “Everything is marketed for the masses, and children are the most vulnerable population, often with rare diseases, so they are never included in FDA clinical trials,” explains Dr. Shah. “We just don’t have the number of patients they need to conduct a trial.”
Instead, cardiologists, and especially electrophysiologists, are left to adapt adult technology without specific FDA approval for pediatric use. Approval of the OmniaSecure™ lead is a meaningful step toward changing that.
Unlike traditional ICD leads, which are about 9 French (a standard unit of measurement equaling about 1/3 of a millimeter) in diameter, the newly approved OmniaSecure™ lead is just 4.7 French — making it a more practical option for children and teens, who have faster heart rates and are more physically active than adults. The heart beats millions of times over a person's life, and an ICD lead has to bend and move with every heart beat, making lead durability and design especially important.
“The baseline rate of ICD lead fractures is already higher in children," says Dr. Shah. "With new cardiac modeling and bench testing, the OmniSecure™ lead was tested under 20% greater strain. The result is an ICD lead design projected for a 10-year fracture-free performance, even in active, growing patients.”
Dr. Shah has so far been able to implant the device in six pediatric patients, children who otherwise would have required open-chest surgery because their bodies were too small for a traditional transvenous lead. CHOP will continue to submit outcomes data on patients ages 12–18 over the next five years to further support the FDA’s recommendation. Dr. Shah believes this landmark approval is the first step in future pediatric-specific device innovation.
“I hope that by the time I retire,” she says, “every manufacturer includes pediatric populations in their studies.”
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In a groundbreaking advance for pediatric cardiac care, the U.S. Food and Drug Administration (FDA) recently approved the OmniaSecure™ lead — the world’s smallest implantable defibrillator (ICD) lead and the first ever granted FDA approval for use in children ages 12 and older. Children’s Hospital of Philadelphia (CHOP) was the only pediatric institution selected to participate in the pivotal clinical trial that supported this approval.
Medical Director of CHOP’s Electrophysiology and Heart Rhythm Program, Maully Shah, MBBS, FACC, FHRS, CCDS, CEPS, served as the sole pediatric investigator on the study’s steering committee. Dr. Shah and CHOP attending cardiologist Chandra Srinivasan, MD, FHRS, CCDS, CEPS, were the only trained pediatric implanters of the new device in the country. “The industry has a lot of confidence in the excellence of care that we provide to our patients at CHOP,” says Dr. Shah. “As a well-known and well-resourced institution, they knew we would have the bandwidth to participate in the trial. Prior to this, the cardiac rhythm management device industry has never worked with a pediatric institution or a pediatric electrophysiologist on the study team pre-FDA approval.”
Implantable defibrillators are devices used to help prevent sudden cardiac death by correcting dangerous heart rhythms. They work by connecting to the heart through a thin, insulated wire called a lead. The lead senses the heart’s rhythm and sends that information to the device. If the heartbeat becomes dangerously fast or irregular, the device sends a signal back through the lead to correct it.
Historically, children have been left out of FDA trials for electrophysiology devices these like. “Everything is marketed for the masses, and children are the most vulnerable population, often with rare diseases, so they are never included in FDA clinical trials,” explains Dr. Shah. “We just don’t have the number of patients they need to conduct a trial.”
Instead, cardiologists, and especially electrophysiologists, are left to adapt adult technology without specific FDA approval for pediatric use. Approval of the OmniaSecure™ lead is a meaningful step toward changing that.
Unlike traditional ICD leads, which are about 9 French (a standard unit of measurement equaling about 1/3 of a millimeter) in diameter, the newly approved OmniaSecure™ lead is just 4.7 French — making it a more practical option for children and teens, who have faster heart rates and are more physically active than adults. The heart beats millions of times over a person's life, and an ICD lead has to bend and move with every heart beat, making lead durability and design especially important.
“The baseline rate of ICD lead fractures is already higher in children," says Dr. Shah. "With new cardiac modeling and bench testing, the OmniSecure™ lead was tested under 20% greater strain. The result is an ICD lead design projected for a 10-year fracture-free performance, even in active, growing patients.”
Dr. Shah has so far been able to implant the device in six pediatric patients, children who otherwise would have required open-chest surgery because their bodies were too small for a traditional transvenous lead. CHOP will continue to submit outcomes data on patients ages 12–18 over the next five years to further support the FDA’s recommendation. Dr. Shah believes this landmark approval is the first step in future pediatric-specific device innovation.
“I hope that by the time I retire,” she says, “every manufacturer includes pediatric populations in their studies.”
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