Cordis said that its SELUTION sustained limus release (SLR) Drug-Eluting Balloon (DEB) has shown sustained benefits in the SELUTION SFA Japan trial as per the 24-month results.
SELUTION SLR is a sirolimus-eluting balloon platform technology. It uses MicroReservoirs that contain a blend of biodegradable polymer and anti-restenotic drug sirolimus.
These MicroReservoirs coat the surface of an angioplasty balloon, delivering the drug in a controlled and sustained manner.
Cordis’ proprietary Cell Adherent Technology (CAT) is said to facilitate the efficient transfer and adhesion of MicroReservoirs to the vessel lumen during balloon expansion.
SELUTION SFA is a prospective, multi-centre, single arm study that evaluated the safety and efficacy of SELUTION SLR.
It assessed the device for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA).
The results from the SELUTION SFA Japan Trial were presented at the Japan Endovascular Treatment Conference (JET) 2024.
The long-term follow-up study of SELUTION SLR DEB has proven effective transfer and retention of sirolimus drug over 24 months, maintaining safety and efficacy in a complex patient population.
At the 24-month mark, the DEB demonstrated a primary patency rate of 83% and 95.4% freedom from clinically driven target lesion revascularisation (CD-TLR).
According to Cordis, the results from the SELUTION SFA Japan trial further validate SELUTION SLR DEB as a safe and effective treatment for femoropopliteal disease.
Cordis chief medical officer and managing director George Adams said: “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 amongst SFA paclitaxel DCB studies and differentiates from other Limus-based devices.
“The ability to achieve durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real world patients.”
The Japanese trial is one of the first of several trials in the SELUTION SLR DEB clinical trial portfolio.
SELUTION SLR was originally developed by Swiss medical technology company MedAlliance which was acquired by Cordis in October 2023.
