United States - 65-- MagPro X100 system

Description

Added: Jun 13, 2019 1:17 pm

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

1.00

LT

$00.00

$00.00

MagPro X100 Magnetic Stimulator 230V Systems

LOCAL STOCK NUMBER: 9016E0711

0002

1.00

BD

$00.00

$00.00

On-site installation and training included in pricing. Extended Warranty Platinum (Free Coil Replacements & Caps), per year:

LOCAL STOCK NUMBER: PW

0003

1.00

LT

$00.00

$00.00

Shipping and insurance

GRAND TOTAL

$00.00

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability of businesses including (but not limited to) 8(a), HUBZone, Service Disabled Veteran-Owned Small Business, and Veteran-Owned Small Business firms relative to the North American Industry Classification Code (NAICS) 339112.

The Department of Veterans Affairs is seeking both manufacturers and/or distributors of the exact match or functionally equivalent equipment/ services to the following listed above.

Statement of Salient Characteristics MagPro X100 TMS Research System

Background

The VISN 17 Center of Excellence (COE) for Research on Returning War Veterans in Waco, Texas, was designated in 2006. Congress instructed the Department of Veterans Affairs (VA) to designate the Waco campus as a Center of Excellence to focus on mental health/post traumatic stress disorder (PTSD) needs. The COE will allow the VA to consolidate personnel, training, and specialized resources in an efficient manner to improve knowledge related to treatment, prevention, rehabilitation, and clinical services to our nation s veterans, with particular focus on those veterans returning from Operations Iraqi Freedom and Enduring Freedom (OIF/OEF).

The primary mission of the VISN 17 Center of Excellence (COE) is to (1) develop, implement, and disseminate research into the causes of PTSD and its effects on combat veterans and their significant others; and (2) provide education for health care specialists and administrators around improved methods of diagnosing and treating individuals with mental health problems, especially veterans. The COE serves as a major source of expertise on the mental health consequences of war to legislative bodies such as Congress, and it serves as an internationally visible focus of research activity on the psychological problems of combat veterans. Administratively, the COE consortium is under the direct control of the Office of Mental Health Services at VA Central Office.

Objective

In support of the above Background, the requested system will; provide the Neuroimaging Core at the CoE with the ability to determine causes, find solutions, and provide treatments for the mental health problems of PTSD and co-occurring depression and TBI.

Scope

The VA requires a repetitive TMS system that meets the requirements as defined below. The vendor shall provide all products and services necessary to complete the tasks outlined. The vendor shall perform all activities to assemble the system equipment to ensure a fully functional system, to include any support systems as applicable. Two rTMS stimulator systems shall be capable of stimulating at a maximum strength of no less than 32 kT/s near the coil surface. The systems must have a documented lineage of substantial equivalence to the medical device with 510(k) number K061053. Biphasic pulse width shall be no more than 290 microseconds. Each stimulator shall have an active cooling system such as water cooling or refrigeration making it capable of delivering no less than 20,000 pulses before warm-up at ambient temperature (20 degrees Celsius), when running a protocol with pulses at full dB/dt, pulse trains at 10Hz, 40 pulses per train, 26-second inter-train interval. A system for head fixation shall ensure that coil placement relative to head position remains constant throughout a treatment session this system should provide adequate resistance to prevent head motion on the millimeter scale, rather than merely providing sensory feedback when such motion occurs. An example of an inadequate head fixation system would be stringing adhesive tape across the patient s forehead. An internal tracking system shall notify the user of coil use over time, and a replacement plan shall cover the cost of replacement coils including shipping after coils have reached their expected end of reliable stimulation. Both systems shall be capable of neuronavigational, providing native support for DICOM and NifTI file formats. Neuron avigation software shall support the visualization of previously recorded functional MRI data in real time. Both systems shall be capable of delivering sham treatment in the form of electrical stimulation to the skin synchronous with the sound of magnetic pulses in placebo-controlled trials, and these electrodes shall emanate from the stimulator coil itself, while no magnetic fields are permitted to stimulate CNS nerve cells in the sham condition. One system shall include a robotic coil placement apparatus which, in conjunction with the included neuronavigational system, allows for the automatic placement of the coil in user-defined locations in a corresponding 3-dimensional model of the patient s scalp based on previously acquired MRI data. This robotic system shall include a sensor that prevents the transmission of force more than ten Newtons to the patient s scalp at any time.

Part # Qty

9016E0711 2 MagPro® X100 Magnetic Stimulator, 230V

9016D0031 2 Isolation Transformer rTMS System

9016B0383 2 Trolley for MagPro (includes coil holder accessories)

9016E0482 2 Coil C-B60 - flat figure of eight coil with built-in power control

9016E0151 1 Coil Cool B65CO - (Axilum TMS-Cobot Edition of the active cooled coil)

9016E0161 1 Coil Cool B65 A/P CO (Axilum TMS-Cobot Edition of the active/sham coil)

9016E0491 1 Coil Cool B65 - dynamic cooled butterfly coil

9016E0501 1 Coil Cool B65 A/P combined active & sham coil

9016S0161 2 Research Software for MagPro R30 / X100 for double blind studies - USB less

9016B0151 2 Coil Cooler for Cool Coils

9016B0171 2 Super Flex Arm for Coil Positioning - long

9016B0081 2 Motorized Procedure Chair with neck rest and cloth cover

9016B0252 2 Head Stabilizer System (Special Vacuum Pillow and Evacuation Pump)

9016B0601 2 Textile Caps - XSmall, Small, Medium, Large, Extra Large-10 pcs.each bundle

Sub-Total for two MagPro systems (1)

7611L1710 2 LocaliteTMS Navigator for Research-Spectra (MRI Based Neuro Navigation System)

Includes, NDI Polaris Spectra (large format) Infrared Tracking camera, Camera stand,

Instruments: Registration Pointer, Calibration Plate, Adhesive Head Reference,

2 Coil Geometry Trackers with MagVenture coil ring brackets to fit the incl. coil handles

Localite TMS Navigator software with remote control for MagPro stimulator, High perf.

PC with large format monitor (24"), Three function footswitch, trigger box, and all

functional data overlay capabilities (MR- based, MR-Less, MEP+Brainmapping, fMRI, EEG)

Sub-Total for two Localite systems (2)

9016ECOB01 1 Axilum Robotics TMS-Cobot TS MV (1)

Configuration includes:

Axilum Robotics Optical tracking system for TMS-Cobot TS MV (1) (2)

TMS-Cobot Coil adaptation kit for MagVenture Cool B65 CO coil (3)

TMS-Cobot Coil adaptation kit for MagVenture Cool B65A/P CO coil (3)

Training Onsite installation and training Included

Sub-Total (3)

*The MagPro R30 and MagPro X100 systems are available for sale in the US. The clinical indications and

recommended use of the devices are limited solely and exclusively to those expressly stated in the

Indications for Use for such devices as cleared by the United States Food and Drug Administration. Any

uses other than those stated in the accompanying product labeling are not cleared or approved in the United

States.

PW Extended Warranty Platinum (Free Coil Replacements & Caps), per year:

First MagPro system * per year.

Second MagPro system * per year.

24 months coverage. Zero Ongoing Costs for life of warranty

Opportunity closing date

20 June 2019

Value of contract

to be confirmed