Cordis Corp., the stent-making arm of healthcare colossus Johnson & Johnson (NYSE:JNJ), said it’s acquired Flexible Stenting Solutions as part of turning its back on the coronary stents market in favor of the endovascular arena.
Bridgewater, N.J.-based Cordis didn’t reveal the purchase price or any details for its buyout of FSS, which makes the FlexStent self-expanding stent. Cordis said the deal is a chance to expand its reach into the peripheral artery disease and, potentially, into the below-the-knee and venous intervention markets.
FSS first won CE Mark approval in the European Union in January 2009 for its FlexStent self-expanding stent to treat vascular disease, which was later expanded to include additional sizes. Later in 2009 the FlexStent device won 510(k) clearance from the FDA later that year for treating malignant bile duct tumors.
"Cordis continues to identify opportunities to enhance its expanding portfolio of less invasive treatment options to address the needs of patients suffering from vascular disease worldwide," Cordis chairman Shlomi Nachman said in prepared remarks. "This acquisition will enable Cordis to provide clinicians more options to meet their evolving therapeutic needs and to strengthen our leadership position in the treatment of vascular disease."
In January Cordis presented 2-year data from a study of the Smart stent in treating patients with obstructive superficial femoral artery disease, touting "excellent" clinical results, including freedom from clinically driven target revascularization at 2 years in more than 80% of enrolled patients, nearly ½ of whom were diabetic and nearly ¼ of whom entered the trial with total occlusions.
Cordis said FSS’s FlexStent is in its own clinical trial under an investigational device exemption for patients with atherosclerosis in the superior femoral artery, aiming to back a pre-market approval bid in the U.S.