Overview

The INCRAFT™ AAA Stent Graft System is an ultra-low-profile, customizable tri-modular device designed for endovascular aneurysm repair (EVAR). It emphasizes efficacy, durability, and ease of use, demonstrated through clinical trials up to 5 years.

Key Specifications and Design Features

• Delivery System: Ultra-low-profile with 13F inner and 14F outer diameter (15F/16F for 34 mm bifurcate), featuring an integrated sheath introducer and advanced device compression technology.
• Tri-Modular Design: Customizable components allow tailored treatment for a broad range of anatomies, including complex and small (<7 mm) vessels.
• Catheter: Highly flexible, hydrophilic coating facilitates smooth navigation through tortuous, calcified vessels, minimizing delivery complications.
• Trans-Renal Fixation: Innovative "cap-free" trans-renal design with flared laser-cut stent and sharpened barbs ensures robust wall anchoring and mitigates migration.
• Modular Junction Strength: Durable polymer-free sealing with interlocking suture knots reduces disconnection and type III endoleaks.
• Fabric and Stents: Seamlessly woven low-porosity polyester graft resists kinking; biocompatible laser-cut nitinol stents minimize micro-motion.
• Radiopaque Markers: Distinctive proximal markers enable optimized placement accuracy and partial repositioning before full deployment.

Clinical Performance and Durability

• Demonstrated efficacy and durability through 5 years in the INNOVATION Trial, with no compromise in AAA repair durability.
• High freedom rates from complications at 5 years, including:
• Type I and III endoleaks
• Stent graft fracture
• Sac enlargement
• Major adverse events (MAE)
• Device migration
• Stent graft patency
• Proven aneurysm sac reduction averaging 7.15 mm decrease at 5 years, with only 8% showing sac enlargement >5 mm.
• Case studies show sustained clinical success and stable aneurysm diameters up to 60 months post-implantation.

Procedural Advantages and Customization

• Designed for minimally invasive PEVAR with simplified access and navigation.
• Conventional delivery techniques are compatible, reducing procedural complexity.
• Real-time bilateral in situ limb adjustments (3 cm ipsilateral, 2 cm contralateral) improve placement accuracy and reduce side-branch coverage risk.
• Few-fit-most concept streamlines inventory and planning with only 4 aortic bifurcate diameters and 19 iliac limb sizes covering a wide oversizing range (3–6 mm).

Recommendations and Usage Notes

• Intended for use by trained vascular interventional physicians and teams.
• Femoral access vessels must be adequate for 14F delivery profile.
• Device specifications may change; consult Cordis representatives for updates and availability.
• Refer to Instructions for Use for detailed indications, contraindications, warnings, and procedural guidance.

Summary

The INCRAFT™ AAA Stent Graft System offers a highly flexible, durable, and customizable solution for EVAR, suitable for a broad patient population including complex anatomies. Its ultra-low-profile delivery system and innovative design features facilitate minimally invasive procedures with proven long-term clinical success and reduced complication rates.