NHLBI SBIR/STTR Contract Topic
070 Bioabsorbable Stents for Pediatric
Pulmonary Artery Stenosis and Aortic
(Fast-track proposals will be accepted)
Number of anticipated awards: 1
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.
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.
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