Australia & New Zealand Society of Vascular Surgeons

The Ancure endovascular graft (Guidant, Menlo Park, CA) entered the US market in 1999 with a pre-marketing agreement (PMA) including a responsibility on the part of the vendor to teach surgeons-interventionalists appropriate deployment techniques and track performance/complications. As experience grew, ‘bail-out’ maneuvers not described in the pre-market trials and not included in the original PMA were identified to aid in graft deployment. The vendor failed to submit PMA supplement to take into account these ‘bail-out’ maneuvers and failed to report implantation complications. These events became apparent in March of 2001 and, as a result, Guidant suspended manufacture and withdrew the Ancure graft from the US market. A new multi center trial was undertaken to study evolving ‘bail-out’ techniques of Ancure graft and the graft returned to the US market in September 2001. Data from the 2001 study was favorable in terms of AAA exclusion and success of the newer ‘bail-out’ techniques yet Ancure market share never recovered. By mid-2003, the Department of Justice filed criminal charges against the corporation. Heavy fines combined with lack of market share and absence of profitability forced Guidant to exit the AAA market. The causes of Ancure’s failure include problems with ease of use, corporate regulatory irregularities, manufacturing complexity, expense, and failure of profitability. The durability of the Ancure graft is arguably excellent compared to other grafts available in the US yet it is the first to exit the market. Qualities beyond durability are necessary for success of an endovascular AAA graft in the US market.