Innovative Stent Graft System Treats AAA

An ultra-low profile endovascular aneurysm repair (EVAR) system prevents infrarenal abdominal aortic aneurysm (AAA) rupture in a wide range of patient populations.

The Cordis (Fremont, CA, USA) INCRAFT AAA system is a modular, bifurcated EVAR system composed of an aortic bifurcate prosthesis and two iliac limb prostheses, each preloaded into its own delivery system. The prostheses are advanced to the intended location over a 0.035” stiff guide wire and under fluoroscopy, aided by radiopaque markers. Once in position, they are deployed to exclude the AAA sac from blood flow. While each patient receives an aortic bifurcated prosthesis and two iliac limb prostheses, additional iliac limb prostheses can be used to extend the device caudally, if needed.

The aortic bifurcate prosthesis itself (available in four diameters) has a flared bare crown with 8 or 10 laser-cut barbs designed to provide fixation in the aorta. The trunk has two sealing stents and a taper stent that divides into the ipsilateral and contralateral legs, each with a series of z-stents supporting the graft material. An integrated sheath introducer, along with a hemostatic valve, facilitates introduction of the aortic bifurcate delivery system and also of the iliac limb delivery system, respectively, into the vasculature.

The iliac limb prosthesis is composed of a series of z-stents, one or more taper stents (if other than a straight configuration), and a caudal diamond or z-stent for sealing. The iliac limb delivery system can be delivered through the integrated sheath introducer of the aortic bifurcate system to ease introduction into the vasculature. All stent grafts are constructed of a woven polyester graft supported by a series of laser-cut, electro-polished, self-expanding nitinol stent-rings, which are sutured internally throughout the implant’s entire length.

“We are excited to announce INCRAFT FDA approval, which will enable high-risk AAA patients in the United States to benefit from more than a decade of investment in research and development and clinical research,” said Patrick Holt, president of Cordis, a part of Cardinal Health (Dublin, OH, USA). “Cordis continues to invest in expanding our product offering to meet our global customers’ needs.”

AAA is the localized dilatation of the abdominal aorta exceeding the normal diameter by more than 50%, and is the most common form of aortic aneurysm; approximately 90% occur below the kidneys. The aneurysms can extend to include one or both of the pelvic iliac arteries. The major complication of AAA is rupture, which is life-threatening, as large amounts of blood spill into the abdominal cavity, and can lead to death within minutes. Mortality of rupture repair in the hospital is 60-90%.