Cordis, a unit of Johnson & Johnson ($JNJ) is seeking an expanded indication for its SMART self-expanding stent, and the device performed well in patients with obstructive superficial femoral artery disease in a 12-month study.
The nitinol stent, already FDA approved to treat iliac arteries, had a one-year patency rate of 81.7%, Cordis said, with no major adverse events after 30 days. Only 1.8% of patients endured stent fractures after a year, and all those reported were Type I, the least severe.
"These outcomes both meet and exceed our expectations for patients with symptomatic disease of the superficial femoral artery," said study investigator William Gray of the Cardiovascular Research Foundation.
An expanded indication for SMART would likely mean bigger stent sales for J&J and Cordis, boosting revenue in a business the company has reined in over the past year. Last summer, Cordis announced it would scale back its stent production, cutting about 1,000 jobs as it changed its focus to other cardiovascular devices. That refocusing hasn't always been smooth, however, as Cordis has had to recall a number of devices over the past year, including balloon catheters and insulin pump cartridges.
- read Cordis' announcement