Structural Heart Steerable Delivery Catheter | Bidirectional ±90°, 12 Fr, Pull-Wire Actuated, TAVR/MitraClip Compatible
Structural Heart Steerable Delivery Catheter | Bidirectional ±90°, 12 Fr, Pull-Wire Actuated, TAVR/MitraClip Compatible
Bidirectional Steerable Delivery Built by Structural Heart Catheter Specialists
The 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.
Bidirectional 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).
The hemostasis valve, Tuohy-Borst adaptor, and rotating thumb wheel handle are assembled under microscope and adhesive-bonded with cyanoacrylate (low-viscosity, <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.
Build Specifications
| Parameter | Value |
|---|---|
| Deflection | Bidirectional ±90° |
| Pull Wire | Dual 0.008 in. SS, opposing lumen layout |
| Pull Force at Full Deflection | ≤2.0 N, per TPW-017 |
| Shaft OD | 12 Fr (0.158 in.) |
| Outer Jacket Zones | Pebax 35D / 55D / 63D (3-zone co-extrusion) |
| Braid | 16-wire 2-over-2, SS |
| Working Length | 110 cm standard |
| Handle | Rotating thumb wheel, Tuohy-Borst, hemostasis valve |
| Bond | Cyanoacrylate <5 cP at polymer-to-metal interfaces |
| Validation | IQ/OQ/PQ available for DHF |
| EtO Compatibility | Yes |
| Regulatory | ISO 13485:2016, FDA Registered, QCBD QMS |
M4D 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&V documentation package available.