Fast-Track proposals will be accepted.
Number of anticipated awards: [1 Phase I, 1 Phase II]
Budget (total costs):
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.
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.
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
9. Electrosurgical connector
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.