The Incraft is an endovascular AAA stent using a 13 French catheter sheath introducer, making for a low-profile, integrated delivery system. The stent is available in the U.S. under Investigational Device Exemption from the FDA.
The INNOVATION trial is a multi-center, open-label, prospective study with sites in Germany and Italy. At the 2-year mark the study found no cases of aneurysm enlargement, endoleaks, device or procedure related major adverse events, stent-graft migrations or stent fractures.
Cordis announced. Only 1 patient had a stent occlusion, but it was attributed to shrinkage of the aneurysm, according to a press statement released at the 2014 Leipzig Interventional Course in Germany.
“We are very pleased with these excellent longer term results and look forward to making our Incraft System available to clinicians in need of alternative therapeutic options for patients suffering from abdominal aortic aneurysms. The Incraft System was designed to address some of the limitations of current AAA stent-grafts and to increase access to this life-saving therapy to a broader range of patients including those with small or diseased vasculature,” worldwide president Celine Martin said in prepared remarks.
Cordis received good news more good news recently when the U.S. Supreme Court denied Dr. Bruce Saffran’s appeal of a $600 million patent infringement decision. The long-running case was thought completed when a $600 million decision landed Saffran’s way in 2011, but Cordis appealed to the U.S. Court of Appeals for the Federal Circuit, which saw it another way and overturned the decision that the Supreme Court then upheld.