078 Transthoracic Cardiac Access Ports and Closure Devices
Annual Phase I Contract Solicitation
(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 www.ncbi.nlm.nih.gov/pubmed?term=21234923,22192372,2192373.
The specific deliverables include:
- Access Port
- Access port in at least two sizes, one being 32Fr and
another 24Fr, to accommodate implantation of large
- The port (“introducer sheath”) should incorporate
features to assure retention inside the endocavitary space
once delivered, to avoid inadvertent exit from the targeted
- The port should have a mechanism to protect against
damage to endoventricular contents (papillary muscles,
chordae tendinae, valve leaflets) during delivery.
- The system should have a hemostatic valve or equivalent
mechanism to allow large appliances to be introduced into
the heart from a transthoracic access port without
significant blood loss and without entry of air.
- The system should feature sufficient taper, rigidity,
and curvature to be introduced into the left or right
ventricle via intercostal and subxiphoid trajectories, and
characteristics to accomplish non-surgical intercostal
separation if necessary.
- The system should allow delivery into the heart through
the chest initially over a 0.035” guidewire
- The port should have length sufficient to reach the
mid-left atrium or proximal ascending aorta from a
transthoracic (subxiphoid and intercostal) access route in
- The system should be conspicuous under multiple imaging
modalities, including ultrasound and MRI.
- The entire system should be MRI compatible (free from
magnetic displacement and from significant magnetic
susceptibility artifact) based on materials compatibility.
- The system should be curved to allow operation within a
large-bore (70cm diameter) MRI system.
- Myocardial Closure System
- The myocardial port must be closed with high
reliability, immediate hemostasis, and with a reliable
bail-out mechanism in case of failure. Targeted clinical
reliability will be successful deployment and immediate
hemostasis in 99.9% of attempts.
- Anticipated closure mechanisms include permanent
implants with suitable fixation mechanisms or
suture-delivery. Any closure mechanism must assure high
reliability of deployment, high reliability of success,
robust immediate hemostasis, extremely low risk of late
erosion or pseudoaneurysm, and trivial or no degradation of
- One minimal mechanism of bailout is a parallel guidewire
that allows a bailout/temporizing hemostatic mechanism to be
inserted quickly and reliably should hemostasis fail, to
allow controlled surgical rescue. Other options are invited.
- The design should be safe from early and late myocardial
- The proposal should include a risk/failure analysis
- Operational considerations should be described,
including whether the closure system is deployed at the
beginning of the transcardiac procedure (“pre-close”) or at
- Strategies should be defined for use and withdrawal of
secondary drainage catheters after the access port is closed.
Phase II Activities and Expected
A phase II award would allow mechanical,
fatigue, and biocompatibility testing and regulatory development for
the device to be used in human investigation, under Investigational
Device Exemption. We expect the device will require a PMA for
marketing, which is expensive. The contracting DIR lab would perform
an IDE clinical trial at no cost to the awardee.
The specific Phase II deliverables are as
described under Phase I.
- The phase II award would consist of the contractor obtaining
an IDE based on the design finalized in phase I.
For more information, see the FY2013 Contract Solicitation or contact OTAC.
Questions and responses pertaining to this topic are available.
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Last Updated August 2012