6515--Repair Specific - Mitral Retractor - IND Amendment - Update…

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation RFQ- 36C25026Q0769 is issued as a request for quote (RFQ). This solicitation document and 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 t