FDA Greenlights IDE Study of Cook Medical’s Drug-Coated Balloon Catheter

The U.S. Food and Drug Administration (FDA) has granted Cook Medical approval to begin an Investigational Device Exemption (IDE) study on the Advance Evero 18 Everolimus-Coated PTA Balloon Catheter (Evero DCB).   

The clinical study will assess the safety and effectiveness of Evero DCB when compared to commercially available paclitaxel-coated balloons for treating peripheral artery disease (PAD). There currently are no everolimus-coated balloon devices commercially available in the United States, and this IDE study is the first U.S. head-to-head evaluation of everolimus- and paclitaxel-coated balloons to treat superficial femoral and popliteal artery lesions. 

The EVERO Trial is a prospective, U.S. multi-center, stratified, blinded, randomized control trial with a parallel pharmacokinetic (PK) study. Cook intends to enroll 410 patients in the pivotal trial and 30 patients in the PK evaluation. 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 from target lesion revascularization (TLR) at 12 months. The primary effectiveness endpoint is primary patency, defined as peak systolic velocity ratio (PSVR) ≤2.4 at 12 months and freedom from clinically driven TLR (CD-TLR) at 12 months.  

“Advance Evero 18 leverages our deep understanding and history of innovation in drug elution therapies for peripheral arterial disease,” Cook Medical Chief Medical Officer Dr. John Kaufman said. “The head-to-head study design will provide the answers that physicians and patients want. I’m confident that Advance Evero will be an excellent complement to our dedicated PAD portfolio aimed at improving long-term clinical outcomes for these patients.”  

Founded on inventing, manufacturing, and delivering medical devices, Cook Medical provides healthcare professionals with the necessary tools to help patients. The company brings new products to market and keeps existing products relevant to a changing healthcare landscape. With headquarters in Bloomington, Ind., and manufacturing facilities and offices in various global locations, Cook Medical strives to maintain a global perspective while focusing on local impact.