Research Project
9042000
The contractor shall deliver transcatheter stents using conventional interventional cardiovascular techniques includingguiding catheters or sheaths, translesional guidewires, and balloon-expandable or self-expanding delivery systems.During Phase I the contractor shall focus on mechanical and biological performance of the proposed biodegradablestents in the intended use for pulmonary artery stenosis and aortic coarctation, taking into account mechanicalstrength required for the application; geometry of the access vessels and geometry and morphology of targetvessels including tapering and branching; strategies to avoid inflammatory restenosis or constriction; and delivery,implantation, and visualization strategies. At the conclusion of Phase I, a candidate device design shall be selected forclinical development based on in vivo performance of a mature prototype resembling a final design. At the conclusionof Phase II the contractor shall obtain an investigational device exemption (IDE), and a supply of devices provided, fora first-in-human research protocol, involving at least 10 subjects, to be performed by the sponsoring NHLBI laboratory.The contractor shall perform or obtain safety-related in vivo experiments and data to support the IDE.
