6515--Repair Specific - Mitral Retractor - IND Amendment - Update Instructions, Provisions, and Clauses

incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026 01, effective 03/13/2026. This solicitation is unrestricted for Full and Open competition. The North American Industry Classification System (NAICS) number is 339112. NOTE: This solicitation is for Mitral Valve Retractor systems specifically designed to support advanced reconstructive mitral valve repair procedures. Retractors intended solely for routine mitral valve replacement or basic atrial exposure do not meet the clinical requirements and will not be considered. All interested companies shall provide quotations for the requirements listed below. Materials and parts will be delivered to: Richard L. Roudebush VA Medical Center, 1481 W. 10th St., Indianapolis, IN 46202, FOB destination. Requirements: LIN Description Qty. 1 FIXED ARM W/ RACK DOWN + MOBILE ARM + KEY/HANDLE 2 2 TRANSVERSE BAR 2 3 MEDIAL RAIL SYSTEM WITH SCREW 2 4 NEW NON-DETACHABLE BRACKET RETRACTOR WIRE BLADE AND ROD, 5MM 6 5 PAIR OF BLADES - 50X40MM FOR RACK DOWN 2 6 PAIR OF BLADES - 70X40MM FOR RACK DOWN 2 7 PAIR OF DUBOST BLADES - 97X40MM FOR RACK DOWN 2 8 LONG AND THIN HOOK FOR MITRAL VALVE, L:270MM W:20MM D:34MM FOR RETRACTOR 4 9 MEDIUM HOOK FOR MITRAL VALVE, L:250MM W:26MM D:34MM FOR RETRACTOR 2 10 LARGE HOOK FOR MITRAL VALVE, L:250MM W:35MM D:34MM FOR RETRACTOR 2 11 TRICUSPIDE HOOK, L:265MM W:35MM D:16MM FOR RETRACTOR 2 Minimum Requirements Lateral Atrial Displacement Mechanism The device shall provide controlled lateral displacement of the left atrium up to 30 mm, allowing enhanced mitral valve exposure without additional sternal spreading. Multi Positional, Adjustable Retraction System The retractor must include: A fixed arm with rack and a mobile arm with key hole style adjustment Capability for rack-up and rack-down configurations for varying exposure needs Interchangeable Sternal Blades (Three Size Categories Required) Blade sets must include at least the following equivalent dimensions: Small blades: approx. 50 mm × 30 40 mm Medium blades: approx. 70 mm × 40 mm Large sternotomy blades: approx. 97 mm × 30 50 mm Advanced Atrial Hooks for Mitral Repair Must include multiple hook options enabling leaflet and commissural visualization, including: Long, thin hooks (approx. 220 270 mm length) Medium hooks (approx. 200 250 mm length) Medial Rail System with Locking Mechanism The retractor must incorporate a locking medial rail capable of maintaining sustained lateral displacement during reconstructive procedures (e.g., annuloplasty, chordal repair). Antero Lateral Atrium Retraction Capability via Transverse Rail System must include a transverse rail with anti rotation secured click in functionality that supports antero lateral atrial hook positioning. Minimal Additional Sternal Spreading Requirement Device shall permit optimized mitral visualization with reduced sternal spreading, supporting reconstructive mitral repair via small or modern sternotomy approaches. Compatibility Across Conventional and Modern Sternotomy Approaches The device must support: Conventional sternotomy Modern sternotomy (7 8 cm incision) Ergonomic Design and Reusable Surgical-Grade Construction The system must: Be fully autoclavable Include ergonomic handles Use robust surgical-grade materials capable of reuse Must Facilitate Advanced Reconstructive Mitral Techniques System must support complex repair procedures including: Multi segment leaflet repair Chordal replacement Annuloplasty Non resectional repair techniques Contact: Rachel MacRae, Contracting Specialist, via email at rachel.macrae@va.gov. No telephone inquiries will be accepted. Only written inquiries received directly for the offeror are acceptable. All quotes must be received by 8/3/2026 by 12:00pm EST to Rachel MacRae (rachel.macrae@va.gov). Offerors must comply with all instructions contained in provision 52.212-1, Instructions to Offerors-Commercial Products (SEP 2023) (DEVIATION OCT 2025), applying to this acquisition. An award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following must be completed to be considered for award: Quote with the following information The solicitation number; The name, address, telephone number of the Offeror; The Offeror s Unique Entity Identifier (UEI) and, if applicable, Electronic Funds Transfer (EFT) indicator; A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary; FAR 52.225-2 Buy American Certificate (attached) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://sam.gov. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition. OR The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Contractor shall provide an authorized distribution letter. The Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized Contractor reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Contractor shall provide new items ONLY; no remanufactured/used or "gray market" items (852.212-71 Gray Market and Counterfeit Items (FEB 2023)). All items must be covered by the manufacturer's warranty. The following additional Provisions apply: 52.212-2 Evaluation - Commercial Products (NOV 2021) (DEVIATION OCT 2025) The Government will award a contract/purchase order resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation and is determined to be the most advantageous to the government, price and other factors considered. The following factors will be used to evaluate offers: Technical Offeror provided documentation evidencing that it can provide the required equipment and whether required features can be provided. Price The Contracting Officer will evaluate price for reasonableness. The Government will evaluate quotes for award purposes to determine the best value. Warranty Quote must provide information regarding warranty of equipment including warranty information and number of years covered. Estimated delivery time and past performance may be considered. (End of provision) 52.252-5 Authorized Deviations in Provisions (NOV 2020) (a)� The use in this� solicitation� of any Federal� Acquisition� Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the provision. (b)� The use in this� soli