(Fast-Track proposals will be accepted.)
Number of anticipated awards: 1
Budget (total costs): Phase I: $200,000
for 12 months; Phase II: $1,500,000 for 2 years
It is strongly suggested that proposals
adhere to the above budget amounts and project periods. Proposals
with budgets exceeding the above amounts and project periods may not
Implanting large appliances, such as
mitral valve replacement, currently requires cardiac surgery and
cardiopulmonary bypass. Minithoracotomy access remains high risk.
NHLBI has shown early feasibility of direct transthoracic large-port
access to the beating heart, and effective closure using nitinol
appliances in animal models. The objective of this contract
solicitation is to support the commercial development of
purpose-built access ports and closure devices for direct
transthoracic cardiac access to the left and right ventricles.
Safe non-surgical access to the beating
heart would be attractive to implant large appliances (such as
mitral valve replacement), to repair complex congenital or
structural heart defects, or to deliver smaller appliances such as
transcatheter aortic valve replacement in the large minority of
patients ineligible for transvascular delivery.
NHLBI DIR has demonstrated early
feasibility of this approach using MRI guidance and off-the-shelf
nitinol closure devices. A purpose-built device would be necessary
for safe and robust transthoracic access port and closure.
Phase I Activities and Expected
A phase I award would develop and test a
port and closure device system prototype. The awardee deliverable
would be tested in vivo in the contracting DIR lab
(cardiovascular intervention program).
Applicants are directed to several
publications from NHLBI regarding this topic in calendar year 2011
(Pubmed ID: 21234923, 22192372, and 2192373), accessible from