NHLBI SBIR/STTR Contract Topic

070 Bioabsorbable Stents for Pediatric Pulmonary Artery Stenosis and Aortic Coarctation

(Fast-track proposals will be accepted)

Number of anticipated awards: 1

Background

Mechanical stents to relieve obstructive cardiovascular lesions could have great utility in pediatric cardiology, but are unsuitable for small children. Commercially available stents limit vessel growth and require future surgical removal. Absorbable stents might revolutionize the treatment of congenital heart disease in children. Small children require small delivery systems for devices that are larger than adult coronary arteries. Specific target diseases include aortic coarctation and pulmonic stenosis, which currently require open surgical repair or multiple X-ray-guided catheter procedures in early childhood.

Specifications

These are transcatheter stents to be delivered using conventional interventional cardiovascular techniques including guiding catheters or sheaths, translesional guidewires, and balloon-expandable or self-expanding delivery systems. Conventional and novel approaches are welcomed.

Specific requirements of the stents include small delivery systems (5-6 French or smaller); sufficient radial force to resist elastic recoil for the two applications; sustained radial strength suited to the application for at least 3-6 months; controlled degradation within 6-9 months; inflammatory response that does not cause significant stenosis, restenosis, or aneurysm; resistance to downstream embolization or toxicity; and nominal calibers suitable for the most common lesions (pulmonary artery stenosis and aortic coarctation, see below) .

Proposed stent nominal geometry should be diameter (6-8mm), length (range 10-25mm), delivery system (5-6 French or smaller). The radial hoop strength of the deployed device should approach that of commercial balloon- expandable stent such as the Cordis Palmaz Genesis. Percutaneous vascular access routes for the pulmonary artery application include femoral and jugular venous. Percutaneous vascular access routes for aortic coarctation application include transvenous-transeptal antegrade and retrograde transfemoral artery. The implant or the delivery system should be conspicuous under the intended image-guidance modality.

Deliverables

At the conclusion of Phase I, a candidate device design should be selected for clinical development based on in vivo performance of a mature prototype resembling a final design.

At the conclusion of Phase II, the offeror should obtain an investigational device exemption (IDE), and a supply of devices provided, for a first-in-human research protocol, involving at least 10 subjects, to be performed by the sponsoring NHLBI laboratory. The sponsoring NHLBI laboratory is willing to perform in vivo proof-of-principal experiments in swine, is willing to collaborate toward design of the clinical protocol, and is willing to provide clinical research services. The vendor is expected to perform or obtain safety-related in vivo experiments and data to support the IDE.

For more information, see the FY2012 Contract Solicitation or contact OTAC.

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Last Updated December 2011