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Cordis reports positive 2-year data for drug-eluting balloon

Cordis reports positive 2-year data for drug-eluting balloon

Cordis Selution SLR drug-eluting balloon
The Selution SLR drug-eluting balloon. (Image courtesy of Cordis)

Cordis today announced positive 24-month results from a study of the Selution SLR drug-eluting balloon (DEB).

Selution SLR provides endovascular therapy for de novo and unstented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA). Cordis acquired MedAlliance’s DEB technology last fall for $1.135 billion. The company presented data from the SELUTION SFA Japan Trial at the Japan Endovascular Treatment Conference (JET) 2024.

Selution SLR provides controlled, sustained drug release, similar to a drug-eluting stent. It features unique microreservoirs made of biodegradable polymer mixed with sirolimus. The microreservoirs ensure a controlled and permanent release of the drug for up to 90 days. MedAlliance’s CAT (cell-adherent technology) allows microdeposits to cover the balloons and adhere to the vessel lumen via an angioplasty balloon.

The balloon was first CE marked for the treatment of peripheral artery disease in February 2020, and subsequently coronary artery disease in May 2020. The balloon is commercially available in Europe, Asia, the Middle East and the Americas outside the US, but remains under investigation in the United States.

Selution SLR was granted the FDA’s first investigational device exemption (IDE) exemption for Selution SLR in indications in May 2022. It received a second IDE in August 2022. These regulatory kinks involve occlusive disease of the superficial femoral artery (SFA). ) and coronary in-stent restenosis (ISR). In January 2023, another IO was performed for the treatment of coronary de novo lesions.

A look at the research data shared by Cordis

The long-term follow-up of the DEB confirmed efficient transfer and retention of sirolimus drugs. It maintained safety and efficacy for 24 months in a complex population that included 60.3% of diabetics.

At 24 months, DEB achieved a 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 conditions.

“The SELUTION SFA Japan trial continues to increase 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 out from other Limus-based devices. The ability to achieve sustainable clinical results in a challenging patient population provides physicians with a solution that will deliver value to real patients,” said Dr. George Adams, Cordis chief physician. “We are excited about the evolution of patient care and to lead that journey by expanding access to Selution SLR DEB.”