The use of stents to resolve obstructions within body passageways is an accepted and successful medical treatment modality. However, traditional metallic stents are not suitable for use where the size of pathway structure changes as it would with a growing child. Hence, the permanency of stents has limited use and creates a particular challenge in treating pediatric patients. Stenting has shown to be efficacious in relieving obstructions associated with pulmonary arterial stenosis (PAS), however, the permanency of the implant has resulted in repeat operations, and limited growth potential of the stented blood vessels. In addition, the size of the patient population and commercial market has deterred larger organizations from focusing on development of devices to treat the pediatric population. The current standard of practice includes surgery, balloon angioplasty and bare metal stenting. Balloon angioplasty is plagued by short term failure for which there is no treatment option and recurrent stenosis. Surgery presents a much higher risk/benefit profile and metallic stenting has limited utility in the smaller child.
The use of bioabsorbable stents to treat obstructions in blood vessels of pediatric patients provides the benefit of stenting and removes the risks associated with a permanent implant (i.e., the need to re-intervene and the long term clinical management of the patient). The development of a bioabsorbable stent system for the treatment of PAS represents a shift in modification of adult product for use in pediatrics to development of a novel system specifically designed for the treatment in children.
The APDC provided both clinical and developmental expertise, as well as increased collaborative efforts to identify additional specialists in the field to see this project forward. This project is funded by APDC. When the project joined the consortium the device was in the prototyping stage of development.