Johnson & Johnson (NYSE:JNJ) subsidiary Cordis is taking its Incraft AAA stent abroad after winning regulatory approvals to market the device in Europe and Canada.

Incraft represents a less invasive option for endovascular repair of abdominal aortic aneurysms (AAA), a condition that affects an estimated 24 million patients worldwide, Cordis said.

"With the launch of the Incraft System, Cordis is bringing an innovative advancement to the field of EVAR, while entering a growth segment that further diversifies our strong product portfolio," Cordis worldwide president Celine Martin said in prepared remarks. "At Cordis, we are proud to deliver market-relevant interventional vascular treatments to address unmet needs, and with the availability of the Incraft System, more patients will have access to an important, new EVAR treatment option."

The Incraft approvals were based in part on results from the INNOVATION clinical trial, launched in 2010, which found no cases of aneurysm enlargement, endoleaks, device or procedure related major adverse events, stent-graft migrations or stent fractures at 2 years following treatment. Only 1 patient had a stent occlusion, but it was attributed to shrinkage of the aneurysm, according to a Cordis statement released at the 2014 Leipzig Interventional Course in Germany early this year.

The Incraft system is not yet approved in the U.S., but it has investigational device exemption for use in clinical trials. Cordis is also pursuing approval in Japan, the company said.

The company may be in the midst of a major shift, as rumors on the street suggest that J&J is looking to divest its Cordis business after years of lackluster sales.