DURABILITY Iliac 9-Month Data Presented and FDA Approves Iliac Use for Covidien's EverFlex Stent

November 5, 2014—Covidien plc announced that US Food and Drug Administration (FDA) has approved the addition of the iliac indication for its EverFlex self-expanding peripheral stent system. In 2006, the FDA cleared the EverFlex for biliary treatment and in 2012 the agency approved the device to treat the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Covidien made the announcement at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.

Also at VIVA 2014, the company announced that Peter Faries, MD, presented 9-month results from the DURABILITY Iliac study confirming the safety and effectiveness of the EverFlex and Protégé GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries. The data were presented during a VIVA 2014 late-breaking trials session. The EverFlex and Protégé GPS self-expanding stent systems are nitinol stent systems that expand to a predetermined diameter to restore blood flow.

Dr. Faries, who is from Mount Sinai School of Medicine in New York, New York, and John Rundback, MD, from Holy Name Medical Center in Teaneck, New Jersey, serve as co-National Principal Investigators of the DURABILITY Iliac study.

In the company press release, Dr. Faries, commented, “The EverFlex and Protégé GPS self-expanding stent systems demonstrated strong patency rates even in difficult to treat calcified lesions in patients with iliac disease. This data, along with the robust EverFlex stent data in the superficial femoral artery, speaks to the clinical versatility of the system.”

According to Covidien, the prospective, multicenter, nonrandomized clinical study enrolled 75 patients at 15 centers in the United States and Europe. Approximately 68% of patients included in the trial had moderately to severely calcified lesions. The study demonstrated 100% device success, and the primary endpoint was met with no major adverse events (MAE) at 30 days and an MAE rate of 1.3% at 9 months.

The company advised that secondary outcomes were also favorable. The 9-month primary patency by Kaplan-Meier analysis was 95.8%, and freedom from target vessel revascularization was 98.6%. Additionally, the investigators evaluated patient quality of life by ankle-brachial index (ABI) and the Walking Impairment Questionnaire (WIQ). The data from the trial demonstrated significant improvements in ABI and WIQ scores at both 30 days and 9 months when compared to the baseline.

The EverFlex system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 180 mm in length in the native SFA and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm to 7.5 mm. The EverFlex is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to and including 100 mm in length, with reference vessel diameters of 4.5–7.5 mm.

Covidien advised that the Protégé GPS self-expanding peripheral stent system is cleared in the United States for biliary use and is currently not indicated for iliac stenosis. The results of the DURABILITY Iliac trial have been submitted to the FDA to support a premarket approval submission for an iliac indication for the Protégé GPS.