22-000616

Post Date/ Solicitation Issue Date

November 15, 2021 12:00 pm

Closing Response Date

November 25, 2021 9:40 am

Proposed Award Date

November 27, 2021 12:00 pm

Project Title

MagVenture Air Cooled Coil MRI-B91 - Mri-compatible stimulation coil

Contracting Office

National Institute of Mental Health (NIMH)

Small Business Size Standard

1000

Competition Status

Brand Name Only

Single-Sole Source Determination

I hereby determine that the MRI-B91 Air Cooled coil listed herein is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.

The essential characteristics of the MRI-B91 Air Cooled coil that limit the availability to a sole source are that they are parts that complete an advanced (higher resolution) MRI-compatible TMS system. They are newly-developed and available, and complete the elements of the system that were previously purchased. The original system enabled a TMS coil to be used in the scanner with a surface MRI coil, but the scanning cababilities of that MRI coil only allowed a fraction of the brain to be imaged, and our study requires full brain scans (something adding the supplemental coil makes possible). It was purchased to test the feasibility and capabilities of the MagVenture TMS/MRI system in our MRI scanner environment before committing to the full system. That testing has been successfully done, but only the completed system will serve to adequately carry out our study.
Only the suggested source can furnish the requirements needed to complete our MRI-compatible TMS system, to the exclusion of other sources, because the system is custom-built only by the MagVenture company, and the requested equipment parts are the only ones available and compatible with our present (incomplete) system.

Background/Description of Requirement

The Experimental Therapeutics and Pathophysiology Branch (ETPB) conducts clinical research on mood disorders with the goal of creating better ways to prevent, diagnose, and treat mental illness. The Non-invasive Neuromodulation Unit (NNU) within the ETPB uses transcranial magnetic stimulation combined with electroencephalography (EEG) recordings to investigate cortical excitability and methods to optimize the efficacy of psychiatric treatments The MRI-B91 Air Cooled coil has much better spatial resolution than the 1 channel head coils currently offered commercially. This allows us to image small subcortical structures in the brain like ventral striatum while applying TMS at the resolution necessary to carry out our study comparisons. However, it is also new technology, so we bought the smaller system (without the supplemental surface coil) in order to test that it would work well in our scanner environment. That testing has been successfully completed, and now we can add the supplemental coil with the assurance that it will work well for us. We can not carry out our study without the completed system. Also, as we play the role of the brain stimulation core of the MRI center, the system will be available to the NIMH for other studies as well, adding a versatile and cutting-edge capability to the center The MRI-B91 Air Cooled coil is needed to support the Study entitled, “Development of Non-Invasive Brain Stimulation Techniques”. This is an essential component for an MRI-compatible TMS System, used for recording MRI with concurrent transcranial magnetic stimulation. Such recordings are fundamental for carrying out our study, which has been reviewed and approved by the NIMH committee for the Scientific Review of Protocols (CSRP) and by the the NIH IRB. Longer and tougher protocols can be run inside the MRI scanner with this Air Cooled MRI coil. The coil is suitable for focused stimulation. Designed for use in MRI scanners up to 4 Tesla with biphasic Waveform Standard mode. Symmetrical placed inside the housing so the magnetic field on both sides is equal. The MRi-B91 Air Cooled has a temperature sensor, which turns the stimulator off, when the coil reaches a specified maximum temperature.