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Tapered Guidewires for Transcatheter Electrosurgery

Description:

Fast-Track proposals will be accepted.
Number of anticipated awards: [1 Phase I, 1 Phase II]
Budget (total costs):
Phase I: $200,000 for 12 months
Phase II: $2,000,000 for 24 months
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 be funded.
Summary
The solicitation will support the small business development of specific guidewire devices to ease and simplify transcaval access to the aorta, to make the procedure available to a wider range of patients and operators.
Project Goals
The goals are to develop and commercialize specific tools to simplify transcaval access to the aorta. The tools are a tapered guidewire and a connector-switch to a common electrosurgery generator. These will greatly simplify transcaval access procedures, reducing the required operator skill, making the procedure more accessible to a wider array of patients and operators, and reduce the cost of the procedure.
Phase I Activities and Expected Deliverables
A phase I award would develop and test a suite of working prototypes in swine. The contracting intramural laboratory wishes to test the final prototype in vivo, and offers an earlier stage test to the contractor at no cost.
Below is a list of individual devices which are part of the suite, along with specific requirements. The devices must be able to function alone or together as components of the multifunctional suite.
8. Tapered transcameral guidewire
a.
Intended to cross a vascular or chamber wall with a 0.014” tip and then seamlessly transition to a rigid 0.35” shaft
b.
Preferred embodiments have a long continuously tapered core, a lubricious and electrically insulating coating except at the tip.
c.
Tip mechanical properties must resemble Asahi Astato XS 20 guidewire
d.
Shaft mechanical properties must resemble Cook Lunderquist guidewire

e.
Approximately distal 10cm is 0.014”, approximately next 20-30cm is tapered, remainder of wire has 0.035” outer diameter. Total length is 2.6-3m
9. Electrosurgical connector
a.
Serves to replace a Bovie electrosurgery pencil connector to a guidewire, otherwise accomplished using a forceps
b.
Connects to the back end of a 0.014” and 0.035” guidewire, such as using a screw-type friction clamp
c.
Connects to a conventional electrosurgery generator such as Medtronic Valleylab FX
d.
Allows controlled actuation only of the “cutting” switch
e.
A preferred embodiment allows a preset time-limit to individual actuations for each button press, such as 1second timeout, before the button is again depressed.
f.
A preferred embodiment also has a switch lockout to assure no inadvertent actuation
Phase II Activities and Expected Deliverables
In addition to meeting all requirements for Phase I, a phase II award would allow commercial introduction of the suite of tools together or independently as 510(k) devices substantially equivalent to marketed predicate devices. If this is not feasible, the phase II deliverable would be all testing and regulatory development for the device to be used in human investigation in the United States, under Investigational Device Exemption, along with devices sufficient to test in 30 human subjects.
The contracting DIR lab offers to perform an IDE clinical trial at no cost to the awardee. Complete IDE documentation and license and a suitable supply of clinical materials would constitute the deliverable.

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