Cordis shares positive 2-year drug-eluting balloon data

Selution SLR, an innovative endovascular therapy, offers treatment options for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Last fall, Cordis acquired this drug-eluting balloon (DEB) technology from MedAlliance for a substantial $1.135 billion. The company recently showcased data from the SELUTION SFA Japan Trial at the 2024 Japan Endovascular Treatment Conference (JET).

Selution SLR is notable for delivering a controlled, sustained release of drugs, akin to a drug-eluting stent. It employs distinctive micro-reservoirs made from biodegradable polymers blended with sirolimus. These micro-reservoirs ensure a steady and prolonged release of the drug for up to 90 days. MedAlliance’s proprietary Cell-Adherent Technology (CAT) allows these microdeposits to coat the balloon and adhere to the vessel lumen via an angioplasty balloon.

Initially, the balloon received CE mark approval for treating peripheral artery disease in February 2020 and for coronary artery disease in May 2020. It is currently available in markets across Europe, Asia, the Middle East, and the Americas, excluding the United States, where it remains investigational.

In May 2022, Selution SLR obtained its first FDA investigational device exemption (IDE) for use in below-the-knee indications. By August 2022, it secured a second IDE, covering occlusive disease of the superficial femoral artery (SFA) and coronary in-stent restenosis (ISR). A third IDE was acquired in January 2023 for treating coronary de novo lesions.

Cordis presented promising long-term study data. The follow-up of the DEB demonstrated efficient sirolimus drug transfer and retention, maintaining safety and efficacy over a 24-month period in a complex patient population, 60.3% of whom were diabetics. At 24 months, the DEB delivered primary patency of 83% and a clinically-driven target lesion revascularization (CD-TLR) rate of 95.4%. According to Cordis, these results represent best-in-class efficacy without compromise, underscoring Selution SLR's consistency as a safe and effective treatment for femoropopliteal disease.

Dr. George Adams, Cordis's chief medical officer, emphasized, “The SELUTION SFA Japan trial continues to build confidence in the Selution SLR DEB technology. The Selution SLR DEB delivers some of the highest patency rates among SFA paclitaxel DCB studies and stands apart from other Limus-based devices. Achieving durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real-world patients. We are excited for the evolution of patient care and to be leading that journey by expanding access to Selution SLR DEB.”

With its robust clinical data, Selution SLR is poised to establish itself as a go-to solution for clinicians treating complex vascular conditions, particularly in patients with a high incidence of comorbidities like diabetes. Cordis’s commitment to advancing this technology could significantly impact future treatment paradigms in endovascular therapy.