6835--NOTICE OF INTENT TO SOLE SOURCE Inhales Nitric-Oxide Gas WEST HAVEN VAMC

STATEMENT OF WORK (SOW) 1. Contract Title. INO Therapeutics 2. Background. The therapeutic use of inhaled nitric oxide is based on its ability to achieve potent and sustained pulmonary vasodilation, without significantly decreasing systemic vascular tone. 3. Place of Performance/Place of Delivery VA Connecticut Healthcare System 950 Campbell Ave. West Haven, CT 06516 Bldg. 1 2nd floor Room 2154 4. Scope. Patients of all ages who are undergoing or have undergone heart surgery and develop pulmonary hypertension. In these patients, INOmax is used to help improve heart function and reduce blood pressure in the lungs. The active substance in INOmax, nitric oxide, is a naturally occurring chemical in the body, which causes the muscles in the lining of the blood vessels to relax. When inhaled, it causes the vessels in the lungs to dilate (widen): this allows blood to flow more easily in the lungs to supply oxygen to the rest of the body and remove carbon dioxide, reducing pulmonary hypertension. It also helps to decrease inflammation in the lungs. It is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the improvement of peri-operative pulmonary hypertension associated with heart surgery. INO selectively decreases pulmonary arterial pressure and improves right ventricular function and oxygenation. INO is already on-site at VACT and is used in the catheterization lab, intensive care units and operating rooms. 5. Specifications. Following requirements must exist for INO to function properly: Complete INOmax DSIR machine with associated parts. INO gas cylinders (800PPM) Calibrations gases NO and NO2 Backup INO blender INO tanks checked and replaced by manufacturer monthly. Recommended vendor Mallinckrodt Pharmaceuticals: Supplies the INO tank, machine for use and disposables needed for INO to be used. 6. Installation: None required, INO is on-site at VACT. 7. Period of Performance. Vendor shall deliver items and check tanks monthly.