6515--Repair Specific - Mitral Retractor - IND

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for quote to be requested with no other form of written solicitation to 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. 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. Vendor to supply necessary materials and/or parts 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: Description Qty. FIXED ARM W/ RACK DOWN + MOBILE ARM + KEY/HANDLE 2 TRANSVERSE BAR 2 MEDIAL RAIL SYSTEM WITH SCREW 2 NEW NON-DETACHABLE BRACKET RETRACTOR WIRE BLADE AND ROD, 5MM 6 PAIR OF BLADES - 50X40MM FOR RACK DOWN 2 PAIR OF BLADES - 70X40MM FOR RACK DOWN 2 PAIR OF DUBOST BLADES - 97X40MM FOR RACK DOWN 2 LONG AND THIN HOOK FOR MITRAL VALVE, L:270MM W:20MM D:34MM FOR RETRACTOR 4 MEDIUM HOOK FOR MITRAL VALVE, L:250MM W:26MM D:34MM FOR RETRACTOR 2 LARGE HOOK FOR MITRAL VALVE, L:250MM W:35MM D:34MM FOR RETRACTOR 2 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 The PO number must appear on all invoices, packing slips, shipping labels, and/or correspondences to the contracting officer....