Cordis reports positive 2-year data for drug-eluting balloon
18 Jun 2024
AcquisitionClinical Result
Selution SLR offers endovascular therapy for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Cordis acquired the DEB technology from MedAlliance for $1.135 billion last fall. The company presented data from the SELUTION SFA Japan Trial at the Japan Endovascular Treatment Conference (JET) 2024.
Selution SLR provides a controlled sustained drug release, similar to a drug-eluting stent. It features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days. MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen through an angioplasty balloon.
The balloon first earned CE mark for treating peripheral artery disease in February 2020, then coronary artery disease in May 2020. It’s commercially available in Europe, Asia, the Middle East and the Americas outside the U.S., but remains investigational in the states.
Selution SLR picked up its first FDA investigational device exemption (IDE) for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August 2022. Those regulatory nods cover occlusive disease of the superficial femoral artery (SFA) and coronary in-stent restenosis (ISR). Another IDE came in January 2023 for the treatment of coronary de novo lesions.
A look at the study data shared by Cordis
The long-term follow up of the DEB confirmed efficient sirolimus drug transfer and retention. It sustained safety and efficacy through 24 months in a complex population that included 60.3% diabetics.
At 24 months, the DEB delivered primary patency of 83% and CD-TLR of 95.4%. Cordis said it achieved best-in-class efficacy results without compromise. The company says the data demonstrates the consistency of Selution SLR as a safe and effective option for femoropopliteal disease.
“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,” said Dr. George Adams, Cordis chief medical officer. “We are excited for the evolution of patient care and to be leading that journey by expanding access to Selution SLR DEB.”
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