An FDA advisory committee panel voted 11 to 4 to recommend the agency grant premarket approval to Cordis’ stent-graft device for abdominal aortic aneurysms, a long-sought win for the company that watched its product undergo review three times before.
A clinical trial of the company’s Incraft endovascular repair system met its primary safety and efficacy endpoints, successfully treating aneurysms located below the kidneys. The device is deployed through the artery and opened to seal and relieve pressure where the aorta splits to supply blood to the legs.
However, rates of subsequent stent fractures and endoleaks—when blood flows outside the graft but inside the aneurysm sac—led the FDA to turn down approval of the device and request more clinical information in July 2015, April 2016 and July 2017 letters to Cordis, as well as call for the June 12 meeting of its circulatory system devices advisory panel.
Cordis, traded from Johnson & Johnson to Cardinal Health in 2015 for $1.9 billion, previously launched the Incraft device in Canada and Europe following regulatory approvals in 2014.
Still, the company’s U.S. setbacks allowed it to capture and analyze five years of safety data, and conduct root cause analyses of the stent fractures, which were submitted to the agency in January. Typically, premarket approvals for endovascular grafts such as Incraft are based on studies lasting one year, plus two years of follow-up, with five-year data following in the postmarket setting, the FDA said.
Cordis said that there were no subsequent injuries, symptoms or clinical consequences observed following a stent fracture, and no secondary interventions required as a result, over more than four years of monitoring.
Fractures were found in 10% of the study’s 190 patients, the FDA said, with additional fractures and propagations being reported as follow-up time increased. The company maintained that the totality of evidence supported the device’s approval.
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Agency reviewers also pointed to a higher-than-normal frequency of type II endoleaks—the most common and least dangerous type, caused by largely benign, retrograde flows of blood from branching arteries.
“Most studies report declining percentages over time with around 10% for longer-term follow-up as compared to the more stable rates of around 36-45% in this study,” the reviewers wrote in their briefing document (PDF) for the advisory panel.
In addition, 29 participants, 15.3%, saw their aneurysm expand following the procedure, with 25 found to be likely attributable to type II endoleaks. Other studies of similar devices have reported percentages between 4% and 12%, the FDA said.
If approved, Cordis has proposed to conduct an observational study in routine clinical practice. The study would enroll about 150 de novo subjects at U.S. sites, with check-ins at 30 days and annually for five years.