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Polymeric Pulmonary Valve

Project Lead: PolyVascular
Year: 

2018

Anticipated Classification:

Class III

Initial Development Stage:

Pre-clinical

Current Development Stage:

Pre-clinical

Congenital heart disease (CHD) is the most common type of birth defect, and one of the leading causes of child mortality in the developed world. One of the most vexing problems that children with CHD face is the poor durability of replacement heart valves, with the pulmonary valve being the most commonly replaced heart valve in children. Until recently, dysfunctional pulmonary valves could only be replaced via open heart surgery, committing these patients to multiple repeat surgeries throughout their lives. The advent of percutaneous pulmonary valve implantation has enabled many thousands of patients to receive new pulmonary valves while avoiding open-heart surgery. Unfortunately, this important advance remains applicable only to older children and adults, due to the bulky delivery systems and the large diameters of the valve implants. Therefore, young children - who rapidly outgrow their valves - sometimes require several open-heart surgeries before adolescence to keep replacing poorly durable valve implants.   PolyVascular has developed a pediatric polymeric pulmonary valve that addresses this important unmet need in the care of children with CHD. Our valve can be fabricated in any diameter, including small diameters for toddlers, which will finally enable small children to benefit from a minimally-invasive valve replacement approach.

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