European Solaris SX Iliac Postmarket Study Presented With 12-Month Data

December 4, 2025—Solaris Endovascular announced 12-month results from the Solaris SX iliac postmarket clinical follow-up study of the company’s non–drug-eluting mechanical scaffold. The data were presented in November at the VEITHsymposium.

The prospective, physician-initiated multicenter trial demonstrated high primary patency, low reintervention rates, and a favorable safety profile across nine European sites for the Solaris SX device, stated the company.

As outlined in Solaris Endovascular’s press release, the findings included the following:

• Primary patency > 95% at 6 months and 94% at 12 months
• Ankle-brachial index improvement from 0.547 at baseline to 0.927 at 12 months
• No device-related serious adverse events through 30 days
• Patent target vessels in 100% of patients with prosthetic arteriovenous grafts (AVG) at 6 months
• Patent target vessels in 91% of patients with native arteriovenous fistulae (AVF) at 6 months

Giacomo Isernia, MD, from Azienda Ospedaliera di Perugia in Perugia, Italy, is Principal Investigator of the study.

“The 12-month results from this multicenter study show consistent and durable performance of the Solaris SX covered stent across challenging iliac anatomy,” commented Dr. Isernia in the company’s press release. “We observed high patency, very few reinterventions, and strong safety outcomes across nine European sites. The performance of Solaris SX in this study reflects the integrity of the stent design and indicates potential utility in broader peripheral arterial applications.”

The company stated that these results follow the 6-month interim outcomes from the DEScover trial of the sirolimus drug-eluting Solaris DE self-expanding covered stent that demonstrated 95% target lesion primary patency at 6 months, 100% procedural success, and no device-related serious adverse events through 30 days. The data were reported at the TCT 2025 scientific symposium in October.