SON Coronary Physiology Platform.docx

Statement of Need (SON) Coronary Physiology Platform

A. GENERAL INFORMATION

1. Purchase: Coronary Physiology Platform

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of need (SON), except as may otherwise be specified. Contractor shall provide (1) Coronary Physiology Platform; (1) Medical Cart with handle;(10) disposable Activation Key Card; (12) Months of customer service fee to be charged every month following the conclusion of the warranty period.

3. Background: Intracoronary hemodynamic measurements are frequently made (approx. 50/month) to determine hemodynamic significance of coronary artery disease to help diagnose patients with symptoms of heart disease and make management decisions. These measurements are performed during invasive coronary angiography and create additional patient risk and expense. The Coronary Physiology Platform removes the need to perform intracoronary hemodynamic by computer processing the already obtained coronary angiograms images and predicting intracoronary hemodynamic measurements with good accuracy. This will allow the management of coronary artery disease in the Veteran population with less procedural risk and expense, including less need for anticoagulation and nitroglycerin, less post-procedural recovery time, and less inadvertent damage of coronary arteries (~1%). The Coronary Physiology Platform will not be connected to the Atlanta VA Health Care System network. The C&A requirements do not apply, and that a Security Accreditation Package is not required.

4. Performance Period and Delivery Schedule: The contractor shall provide the specific deliverables described below within the performance period stated in this SON, unless otherwise directed by the Contracting Officer (CO). Delivery will be to the Atlanta VA MC 1670 Clairmont Rd. Decatur GA 30033 (Logistics).

a. Task One: The vendor will ensure delivery of equipment within 30 days of award.

b. Deliverable One: The vendor shall provide (1) Coronary Physiology Platform; (1) Medical Cart with handle;(10) disposable Activation Key Card; to the Atlanta VAHCS warehouse within thirty (30) days of the award via UPS, FedEx, USPS to Atlanta VA Healthcare System 1670 Clairmont Rd Decatur, GA 30033.

5. Type of Contract: Firm-Fixed-Price

B. GENERAL REQUIREMENTS

For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, and along with associated sub-milestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed work plan.

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms not required.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SON.

Task One: The contractor shall provide an exact match to the listed product needed within 30 days.

Deliverable One: Delivery is by a third-party entity i.e., USPS, UPS, FedEx, etc. to be shipped to:

Atlanta VA Medical Center c/o Logistics 1670 Clairmont Road Decatur GA 30033

Task Two: The delivery schedule will be met; unless requested by the Contracting Officer, COR, or Logistics Inventory Specialist.

Deliverable Two: The contractor will agree to the delivery schedule.

D. CHANGES TO STATEMENT OF NEED

Any changes to this SON shall be authorized and approved only through written correspondence from the CO.

6. Salient Characteristics:

· A wire-free coronary physiology platform that uses routine angiograms to generate 3D, vessel-by-vessel Fractional Flow Reserve values across the coronary tree.

· Designed to help physicians assess lesion significance and guide PCI decisions inter-procedurally.

· Uses artificial intelligence and advanced computational science to derive physiologic information from routine angiograms.

· Provides real-time Fractional Flow Reserve values throughout the coronary tree, including multi-vessel assessment and side branches.

· Creates a 3D reconstruction of the coronary tree from angiographic images that Is performed during the angiogram procedure, avoiding invasive pressure wires and drug induced hyperemia.

· Use a resistance-based computational model and aortic pressure to reconstruct coronary physiology.