Cook’s Advance Evero 18 Everolimus-Coated Balloon IDE Study Plan Approved by FDA

August 20, 2025—Cook Medical announced that the FDA has granted approval for the company to initiate an investigational device exemption (IDE) study of the Advance Evero 18 everolimus-coated percutaneous transluminal angioplasty balloon catheter.

According to the company, the clinical study will assess the safety and effectiveness of the Evero everolimus-coated balloon when compared to commercially available paclitaxel-coated balloons for the treatment of peripheral artery disease.

The head-to-head evaluation will study everolimus- and paclitaxel-coated balloons in the treatment of lesions of the superficial femoral and popliteal arteries.

Cook Medical stated that the EVERO trial is a United States prospective, multicenter, stratified, blinded, randomized controlled trial with a parallel pharmacokinetic (PK) study. The company intends to enroll 410 patients in the pivotal trial and 30 patients in the PK evaluation.

The company advised that the primary safety endpoint is a composite of freedom from device- or procedure-related death at 30 days, freedom from target limb major amputation at 12 months, and freedom from target lesion revascularization (TLR) at 12 months. The primary effectiveness endpoint is primary patency, defined as peak systolic velocity ratio ≤ 2.4 at 12 months and freedom from clinically driven TLR at 12 months.

The Evero everolimus-coated balloon is an investigational device, limited by United States law to investigational use, cautioned Cook Medical.