{"product_id":"structural-heart-steerable-delivery-catheter-bidirectional-90-12-fr-pull-wire-actuated-tavr-mitraclip-compatible","title":"Structural Heart Steerable Delivery Catheter | Bidirectional ±90°, 12 Fr, Pull-Wire Actuated, TAVR\/MitraClip Compatible","description":"\u003ch2\u003eBidirectional Steerable Delivery Built by Structural Heart Catheter Specialists\u003c\/h2\u003e\u003cp\u003eThe M4D LLC Structural Heart Steerable Delivery Catheter is a bidirectional, pull-wire–actuated delivery system built by engineers with 70+ years of combined structural heart and endovascular catheter experience, and manufactured under ISO 13485:2016 quality management with full IQ\/OQ\/PQ validation documentation available for customer DHF submission.\u003c\/p\u003e\u003cp\u003eBidirectional deflection is achieved through a symmetric dual-lumen pull-wire architecture: two 0.008 in. SS pull wires run in opposing Pebax 72D strain-relief sleeves through the full catheter working length (110 cm standard), with distal termination via micro-TIG welded SS anchor plates that distribute pull force uniformly across the braid layer. The outer shaft is a 12 Fr co-extruded Pebax 63D\/55D\/35D three-zone body over a 16-wire 2-over-2 SS braid, providing pushability through the aortic arch while permitting the distal 4 cm to deflect through ±90° without pull-wire load exceeding 2.0 N at full deflection (bench tested per M4D TPW-017).\u003c\/p\u003e\u003cp\u003eThe hemostasis valve, Tuohy-Borst adaptor, and rotating thumb wheel handle are assembled under microscope and adhesive-bonded with cyanoacrylate (low-viscosity, \u0026lt;5 cP) at all polymer-to-metal interfaces. Compatible with TAVR prostheses, MitraClip delivery, and LAA closure sheath systems up to 14 Fr delivery outer diameter.\u003c\/p\u003e\u003ch2\u003eBuild Specifications\u003c\/h2\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003cth\u003eParameter\u003c\/th\u003e\n\u003cth\u003eValue\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDeflection\u003c\/td\u003e\n\u003ctd\u003eBidirectional ±90°\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePull Wire\u003c\/td\u003e\n\u003ctd\u003eDual 0.008 in. SS, opposing lumen layout\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePull Force at Full Deflection\u003c\/td\u003e\n\u003ctd\u003e≤2.0 N, per TPW-017\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eShaft OD\u003c\/td\u003e\n\u003ctd\u003e12 Fr (0.158 in.)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eOuter Jacket Zones\u003c\/td\u003e\n\u003ctd\u003ePebax 35D \/ 55D \/ 63D (3-zone co-extrusion)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eBraid\u003c\/td\u003e\n\u003ctd\u003e16-wire 2-over-2, SS\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWorking Length\u003c\/td\u003e\n\u003ctd\u003e110 cm standard\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eHandle\u003c\/td\u003e\n\u003ctd\u003eRotating thumb wheel, Tuohy-Borst, hemostasis valve\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eBond\u003c\/td\u003e\n\u003ctd\u003eCyanoacrylate \u0026lt;5 cP at polymer-to-metal interfaces\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eValidation\u003c\/td\u003e\n\u003ctd\u003eIQ\/OQ\/PQ available for DHF\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eEtO Compatibility\u003c\/td\u003e\n\u003ctd\u003eYes\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eRegulatory\u003c\/td\u003e\n\u003ctd\u003eISO 13485:2016, FDA Registered, QCBD QMS\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e\u003cp\u003eM4D LLC manufactures steerable delivery catheters for structural heart applications including TAVR, MitraClip, and LAA closure. Bidirectional deflection, 12 Fr co-extruded Pebax shaft, dual pull-wire architecture. Full V\u0026amp;V documentation package available.\u003c\/p\u003e","brand":"M4D LLC","offers":[{"title":"Default Title","offer_id":50370551414951,"sku":null,"price":1950.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0754\/8842\/8199\/files\/image_6b391a8e-df51-4773-987c-d375a3626c0b.png?v=1779877203","url":"https:\/\/m4dally.com\/products\/structural-heart-steerable-delivery-catheter-bidirectional-90-12-fr-pull-wire-actuated-tavr-mitraclip-compatible","provider":"M4D LLC","version":"1.0","type":"link"}