Guiding devices to market, and mending broken hearts

by Tom Ulrich on March 25, 2011

A biodegradable patch for repairing ventral septal defects (VSDs).

Imagine: You’re a pediatric cardiologist who for years has worked on the design of a device that could revolutionize the treatment of a severe atrial arrhythmia. But while you can find a lot of assistance and advice for bringing devices for adults to market, you find little help for devices intended for infants and children. What can you do?

The U.S. Food and Drug Administration could be your best friend. Better known for its role in establishing and enforcing regulations for drug and device safety and information, the FDA is also an advocate, helping bring innovative devices for pediatric treatment into clinical practice. Pedro del Nido, chief of cardiac surgery at Children’s Hospital Boston, outlined the FDA’s advocacy role last week at the monthly Innovators’ Forum hosted by the Children’s Innovation Acceleration Program.

Pediatric devices come out years after analogous devices for adults reach the market. del Nido spoke of the unique challenges behind this delay: Children differ in size, growth, and body chemistry; their activity levels vary greatly; the market for pediatric devices is small; reimbursement is limited. And because there are fewer patients, it can be difficult to gather the data required for FDA approval of high-risk devices.

“Designers often end up adapting the designs of adult devices for pediatric use,” he noted, “even though those designs may not be appropriate for use in kids.”

This is where the FDA’s advocacy role comes into play. In 2004 and 2007, Congress passed legislation that empowers the FDA to address the inherent obstacles and help new devices make it to the patient’s bedside. The two acts gave the FDA a number of duties – such as modifying safety and probable benefit guidelines, encouraging interactions between pediatric clinicians and industry, and creating networks of hospitals and other facilities with pediatric expertise – aimed at stimulating the development of devices for children.

The 2007 legislation also created the Pediatric Device Consortia Grants Program, which currently supports four partnerships dedicated to pediatric device development. del Nido leads one of the four: the Pediatric Cardiovascular Device Consortium, a partnership between Children’s, the Georgia Tech College of Engineering, the New England Research Institutes, and the National Heart, Lung, and Blood Institute’s Pediatric Heart Network. The consortium has clinical trial, engineering and regulatory & commercialization cores that provide valuable infrastructure and mentorship for device developers.

Looking inside: Image capture from a 3D echocardiograph system being developed with the help of the Pediatric Cardiovascular Device Consortium.

The consortium is already guiding four projects through the design and approval process: improved 3D echocardiographic imaging for diagnostics and surgical planning, a new generation of pediatric vascular assist devices, and two devices for pediatric heart valve repair or replacement.

Nora Lang, a fellow in del Nido’s laboratory and his co-presenter at the Innovators’ Forum, is the kind of innovator who could benefit from the consortium’s expertise and the FDA’s expanded advocacy role. Lang is working with several collaborators to improve the treatment of ventricular septal defects, or VSDs.

The most common congenital heart defects, VSDs are essentially holes between the right and left sides of the heart. These holes allow blood to leak from one side to the other, increasing the blood pressure in the lungs and potentially making it harder for the heart to pump effectively. Perimembranous VSDs, which are located close to valve leaflets and electrically conductive tissue, are particularly tricky to close.

While VSDs can be treated surgically, the operation can be quite invasive and requires cardiopulmonary bypass. VSDs can also be closed with catheter-delivered devices, but current devices, which trap and compress tissue, can damage electrically conducting tissue, potentially requiring patients to receive a pacemaker.

In the forum, Lang described her work on a new biodegradable patch, delivered by a catheter, and a novel, light-activated adhesive to anchor it into place while the heart is still beating.

Lang’s work is just one example of the kinds of innovative devices that, with the help of del Nido’s consortium, can be put in the hands of doctors and surgeons to help mend children’s broken hearts. And hopefully, if the FDA’s advocacy role in this arena continues to expand rationally, investors and companies will see the opportunity to bring additional innovations to market and have a real impact on how hospitals like ours treat some of our smallest patients.

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