071 Electrophysiologic Catheters for Interventional MRI Ablation of Ventricular Tachycardia
NHLBI SBIR/STTR Contract Topic
(Fast-track proposals will be accepted)
Number of anticipated awards: 1-2
Catheter-based ablation therapy is used to treat
cardiac rhythm disorders. MRI may have value in
targeting and assessing ablation lesions
interactively during catheter based cardiac
electrophysiology (EP) procedures. Real- time MRI EP
ablation may be especially attractive to ablate
mid-myocardial targets causing ventricular
tachycardia in adults and children.
While technically feasible, there are no
commercially available flexible catheter devices to
perform EP ablation that are conspicuous and safe
under real-time MRI guidance. Such technology, if
commercialized, would enable novel treatments for
The offering resembles a “conventional”
deflectable multipolar catheter used to perform EP
ablation procedures in geometry and in mechanical
performance. These must be specified.
The offering must be conspicuous during MRI at
1.5T using “profiling” techniques such that positive
contrast is provided along the entire intravascular
device shaft and tip. The preferred catheter design
for profiling is “active” such that the offering
incorporates an intravascular MRI coil that allows
the device and tissue to be imaged simultaneously.
Alternative designs will be considered that provide
high conspicuity during MRI.
The device must be able to obtain multi-channel
local intracardiac electrograms. Suitable filtering
functionality must be provided to connect the system
to a commercial clinical EP recording and mapping
The device should be suitable for transcatheter
endocardial application and for transthoracic
intrapericardial epicardial application.
The device must be capable of radiofrequency
ablation of ventricular myocardium during
uninterrupted magnetic resonance imaging, which may
require appropriate filtering. Alternative ablative
energy sources may be proposed. Saline irrigation,
or alternative target tissue cooling, should be
integrated into the ablation system.
The device should interoperate during MRI with at
least two other similar catheters that provide
multipolar electrogram recording capability.
The offeror should consider capabilities to
perform ventricular defibrillation in the MRI
environment. The offering should operate with the
interventional MRI system of the sponsoring NHLBI
laboratory. The NHLBI currently uses 1.5T Siemens
MRI systems and the proposed transmit-receive system
must be compatible with these scanners (more details
will be made available upon request). The offering
must be “MRI safe” or “MRI contingent” to allow
future clinical procedures, without heating or local
magnetic field disruption according to accepted
industry standards and should be designed for safety
in a clinical environment. Control of the system
should be possible from a bedside operator and from
a console-based operator outside the radiofrequency
MRI system shield. The system should not generate
radiofrequency noise that interferes with MRI at
1.5T. The system should be safe for operators and
patients inside and near the magnet bores. The
system should not interfere with common commercial
Bluetooth and other common radiofrequency patient
physiologic telemetry systems used during MRI.
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
system nearing final design lock.
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, contact OTAC.
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Last Updated December 2011