6515--Equipment, Neurostimulation Device for Investigational, Ann Arbor

Notice of Intent to Sole Source Requirement

The Department of Veterans Affairs, VA Healthcare System, VISN 11 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1, Only One Responsible Source for the following items listed below. The associated NAICS code for this medical equipment is 334510. The vendor, Cocart, LLC, is a small business, located at 101 S. Reid St., Suite 307, Sioux Falls, SD 57103-70454.

Description of equipment requirements:

The Bohnen lab is requesting five Transcutaneous Vagus Nerve Stimulation Research (tVNS R) devices from tVNS USA, sold by CoCart LLC. The tVNS R devices provide a non-invasive transcutaneous auricular vagal nerve stimulation. The device is a non-invasive treatment option that provides mild electrical stimulation to the auricular branch of the vagus nerve, which is accessible from the outer part of the ear. The vagus nerve allows for communication between the brain with many parts of the body, such as the heart, lungs, and digestive tract. The device itself is similar in appearance to a music playing device with earphones that connect to the outer portion of the ear and a long wire that is connected to a control box. These devices will provide therapeutic electrical impulses that are designed to alleviate symptoms of disorders that may be related to sympathovagal dysfunction, such as Parkinson s Disease (PD). This stimulation may be able to improve heart rate variability. Novel emerging evidence from the literature has uncovered that decreased heart rate variability (HRV) both at rest and during walking could be a fundamental but, until recently, an unrecognized factor in the pathophysiology of freezing of gait (FoG), which is often considered one of the most debilitating symptoms of PD. Individualized HRV-informed programming of in-home use of a tVNS neural stimulator may offer a very novel therapy to treat gait disturbances, including FOG, in Veterans with PD. The tVNS R devices by tVNS USA, sold by CoCart LLC offer easily programable stimulation devices that can be adjusted to provide prescribed treatment to those with PD.

A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This is not a Request for Proposal; this is a Notice of Intent to Sole Source requirement.