Vascular Perfusion Solutions Nabs Grant for Pediatric Heart Transplant Preservation Device

San Antonio, Texas-based startup Vascular Perfusion Solutions Inc. (VPS) has received a $25,000 grant from the Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC) to develop its current VP.S ENCORE cardiac preservation technology as a portable pediatric device. Early activities supported by the grant include preclinical testing of pediatric hearts to adapt the VP.S ENCORE PEDS (Pediatric Enhanced Delivery System) and developing anatomically appropriate modifications for the use of pediatric patients, especially 0-5 years old.
 
“Development of a pediatric perfusion device is critical for expanding the donor pool and improving outcomes in pediatric cardiac transplantation,” said Joseph Turek, M.D., Ph.D., a pediatric heart surgeon with more than 20 years’ experience who performed the world’s first partial heart transplant on a newborn. “Unfortunately, children are an underserved population when it comes to innovation, adaptation of technology, and clinical trials. It is our duty to advocate for them and to continue to advance the care in pediatric medicine.”
 
Although there currently is a great need for pediatric medical devices, their development is influenced by economic, clinical, and regulatory challenges, as well as a lack of established mechanisms for industry partnerships. The SWPDC prize is designed to foster device innovation for kids.
 
Pediatric heart failure presents unique challenges compared to its adult counterpart, stemming from diverse causes such as congenital heart defects and cardiomyopathy. Despite different manifestations, heart transplantation remains the standard for end-stage heart failure in both adults and children.
 
In 2021, 1,146 pediatric heart transplant candidates awaited transplantation, with more than 40% enduring waits of 12 months or more. Particularly concerning are outcomes for infants under a year old, with 23% succumbing to end-stage heart failure while on the waitlist.
 
Donor heart ischemic times, notably ≥ four hours, are associated with poorer one-year post-transplant survival, posing greater risks to younger recipients. Despite this, more than 40% of infant heart transplants exceed the four-hour limit, influenced by factors such as the shortage of available donors and the need for complex reconstructive surgeries during transplantation.
 
“We are honored to be recognized by SWPDC for the potential to apply our technology to the pediatric patients,” VPS Scientific Director Dr. Kristina Andrijauskaite said. “We will expand our efforts to target additional funding in the coming months and look forward to developing a true solution for these children in need.”
 
Vascular Perfusion Solutions advocates for increasing heart transplant utilization rates in underserved populations by expanding geographic region, maintaining organ viability, and improving surgical outcomes in pediatric heart transplantation.
 
The VP.S ENCORE cardiac preservation device, tested in more than 100 ovine, porcine, and human donor hearts not utilized for transplant, provides a simple, portable method for preserving and transporting hearts for transplantation and maintaining tissue viability longer than the current standard of care. The key is the perfusion of hypothermic, oxygenated, acellular (no blood) nutrient rich solution to the coronary arteries. The VP.S ENCORE has been awarded Breakthrough Designation by the U.S. Food and Drug Administration (FDA) and is currently undergoing preclinical testing for its first indication of use for standard criteria hearts in the United States, Latin America, and Europe.
 
San Antonio-based VPS develops prolonged organ preservation technologies for use before transplants.
 
SWPDC is a multi-institutional consortium that is supported by an FDA P50 grant, anchored by Texas Children’s Hospital (TCH) and Baylor College of Medicine (BCM), and is dedicated to improving children’s health by supporting pediatric device innovators.