This project offers the opportunity to leverage Dura Biotech technologies to develop and commercialize a transcatheter pulmonary valve replacement (TPVR) device, Joyce Fit TPVR system, to treat congenital heart defects (CHD) in patients with right ventricular outflow tract (RVOT) and pulmonary valve (PV) dysfunctions. CHD affects nearly one in every 100 babies, approximately 40,000 babies in the US and over 1,000,000 babies worldwide . It is estimated that about 20% of these children are born with RVOT and PV dysfunctions. These pediatric patients are typically subjected to multiple invasive open-heart surgeries throughout their lifetime in order to reestablish normal blood flow from the heart to the lungs.
- Joyce Fit TPVR offers a longer Nitinol frame with an optimized stent radial expansion force to prevent damage (and over dilation) of the native vessel,
- The frame contains a unique rigid valve-housing section that allows for proper anchoring in the pulmonary trunk without the need for pre-stenting, and prevents distortion of the leaflets which is important for TPV function and durability,
- The unique flexible frame that is designed to conform to the native pulmonary curvature,
- The unique leaflet design designed to maintain leaflet coaptation even with over expansion of the stent due to dilation of the main pulmonary artery.
 Congential heart defects, data and statistics. https://www.cdc.gov/ncbddd/heartdefects/data.html
Note: Dura TPVR is not approved for investigational use or sale in the United States.