Procyrion Awarded $50,000 Pediatric Device Innovation Grant

Procyrion Inc., a medical device firm developing a catheter-deployed circulatory assist device for long-term use in the treatment of chronic heart failure, has been awarded a $50,000 grant from the National Capital Consortium for Pediatric Device Innovation. The award is part of the U.S. Food and Drug Administration’s (FDA) Pediatric Device Consortia grant program.

Procyrion’s Aortix device is a small, continuous-flow pump mounted within a self-expanding anchoring system and delivered via catheter through the femoral artery to the descending thoracic aorta. Once the catheter sheath is pulled back, nickel-titanium anchors deploy to anchor the pump to the aortic wall. Aortix functions by accelerating a portion of the native aortic flow, resulting in reduced work of the heart and increased blood flow to vital organs.

The grant funds are being used in partnership with maxon precision motors of Fall River, Mass., to modify the adult Aortix device for use in children born with single ventricle heart defects. “The commercialization path of pediatric medical devices presents unique challenges due to limited market size; maxon precision motors is proud to help meet those challenges and work with Procyrion to develop an efficacious tool for this important unmet clinical need,” said Christopher Blake, president of maxon precision motors.

maxon precision motors is donating a supply of modified motors and engineering support to help optimize the circulatory assist device for pediatric use.  In addition to adapting the device to fit a child, the Procyrion team already has begun optimizing the flow profile needed to clinically manage single ventricle physiologies associated with the Fontan procedure.

“Many devices for adults are not suitable for pediatric use, but the small form factor of Aortix makes it very useful for the pediatric patient. With minor modifications, we hope to create a first-in-class device for pediatric patients with failing Fontan circulation.  Receiving this grant reflects confidence our product can impact the underserved pediatric medical device market,” said Ben Hertzog, president and CEO of Procyrion.

Procyrion also is collaborating on the pediatric device with Charles Fraser, M.D., chief of congenital heart surgery and cardiac surgeon-in-charge, and Daniel Penny, M.D., chief of pediatric cardiology, at Texas Children’s Hospital. “This is a promising technology with many potential applications,” said Fraser.

The grant program places special emphasis on helping bridge the gap that often follows the prototyping phase to help manufacture, clear, market and sell the device.