Jarvik Launches Clinical Trial For Miniaturized Cardiovascular Implant
The FDA has approved an investigational device exemption (IDE) clinical trial to investigate a left ventricular assist device (LVAD) system small enough for use in infants and children. The Jarvik 15mm device, introduced earlier this year by Jarvik Heart, is adjustable for long-term use in children as they grow and wait for a suitable heart transplant.
LVAD systems, which attach to the left ventricle to help heart muscles weakened by disease maintain a healthy rhythm, have become the standard of care for heart failure patients. Pediatric patients typically are too small to accommodate adult-sized implantable models, and must instead be fitted with external systems that have a higher risk profile.
Earlier this year, Jarvik Heart researchers — in conjunction with the National Heart, Lung, and Blood Institute (NHLBI) — presented a miniaturized LVAD that had demonstrated success in a clinical trial with sheep models. Data from that trial was submitted as part of the company’s IDE application to the FDA.
“We are excited about bringing this miniaturized pump design to pediatric heart failure patients after a decade of intense engineering effort,” said Robert Jarvik, inventor of the device and chairman of Jarvik Heart, which gained fame in the early ‘80s with the introduction of Jarvik-7, a completely artificial heart. Jarvik noted in a press release that the design of the pediatric LVAD was based on over fifteen years of experience with the adult LVAD model and work on the system’s predecessor, the Jarvik 2000.
Pediatric devices present significant design challenges to engineers because of the size, activity levels, and the rapid growth rate of pediatric patients, especially infants. Former FDA commissioner Margaret Hamburg, during a keynote address at the 2nd Annual Pediatric Surgical Innovation Symposium in 2014, noted that it was not enough to take a device indicated for adult use and scale it down.
To address the unique needs of children, engineers at Jarvik Heart included an adjustable control system, which allows clinicians to adjust blood flow speed as the child grows. The 15mm device, which is roughly the size of an AA battery, is suitable for infants through children up to about age 10, and is an option for long-term use as the child waits for a transplant.
The Pump for Kids, Infants, and Neonates (PumpKIN) study will be centered at the New England Research Institutes and will enroll 88 patients at 20 different sites in the U.S. and Canada. Trial participants will randomly receive either the Jarvik system or Berlin Heart’s Excor Pediatric LVAD System, which was approved by the FDA in 2011. The study will compare the two systems as a “bridge to transplant” over a six-month period.
“We are thankful for the NHLBI program, without which this effort to provide lifesaving support for children would not have been possible,” said Peter Hinchliffe, president of Jarvik Heart. “We look forward to the day when infants and children will be able to receive a fully-implantable LVAD that will enable a greatly-improved quality of life over currently available options.”
In 2015, St. Jude Medical launched HALO, an IDE clinical trial to test its Masters HP series 15mm mechanical heart valve in pediatric patients. Over 40 different sites will collect data that will be used to apply for FDA approval, but the device currently is available under the agency’s “compassionate use” protocols.”