Cook Medical's Advance Evero 18 Receives FDA IDE Approval for First Head-to-Head Trial Against Paclitaxel-Coated Balloons

Cook Medical Announces FDA Approval of ItsEverolimus-Eluting Balloon Catheter---Advance Evero 18of IDE research (EVERO). This is FDA-approvedThe First Everolimus in the United StatesDrug-Eluting Balloon CatheterWith PaclitaxelDrug-Eluting Balloon CatheterHead-to-Head Clinical Study on the Treatment of Superficial Femoral Artery and Popliteal Artery Lesions. Currently, Everolimus is Not Available in the U.S. MarketDrug-Eluting Balloon CatheterListing.

EVEROThis is a prospective, multicenter, stratified-blinded, randomized controlled study with a concurrent pharmacokinetic (PK) substudy. Cook Medical plans to enroll 410 patients in the pivotal trial and 30 patients in the PK assessment. The primary safety endpoint is a composite endpoint comprising freedom from device- or procedure-related mortality within 30 days, freedom from major amputation of the target limb within 12 months, and freedom from target lesion revascularization (TLR) within 12 months. The primary effectiveness endpoint is primary patency, defined as a peak systolic velocity ratio (PSVR) ≤2.4 at 12 months and freedom from clinically driven TLR (CD-TLR) within 12 months.

Executive Evaluation

“Advance Evero 18 embodies our deep-rooted innovation in drug-eluting therapies for peripheral artery disease. The head-to-head study design will provide definitive clinical answers for physicians and patients, and I believe this product will be a significant addition to our dedicated peripheral artery disease portfolio, offering robust support for improving long-term clinical outcomes.”

---John Kaufman  Chief Medical Officer, Cook Medical