A trial of Boston Scientific's ($BSX) Epic self-expanding nitinol stent system met its primary endpoints, signaling a win for the company as it attempts to get FDA clearance for the product. The company submitted data in support of Epic, which has CE Mark approval, in the fall.
Data from the Orion trial, which included 125 patients with iliac artery disease, were presented at the International Symposium on Endovascular Therapy in Miami. The trial met its primary endpoint, a composite rate of major adverse events—including myocardial infarction, target vessel revascularization and amputation—at 9 months. In fact, it did extraordinarily well, demonstrating a 9-month MAE rate of 3.4% in the intent-to-treat population—far lower than the goal of 17%.
"The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems," said Jeff Mirviss, president of the company's peripheral interventions business, in a statement. "Upon approval, the Epic Stent, along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients."
As Zack's notes, Boston Sci has strengthened its peripheral interventions stent systems recently, launching the Charger balloon catheter, Mustang angioplasty balloon and the Coyote balloon catheter last year. In addition, the company made a couple of strategic buys—S.I. Therapies and ReVascular Therapeutics—to further bolster itself in this arena.
Still, devicemakers, including Boston Sci rivals Medtronic ($MDT) and St. Jude Medical ($STJ), are seeing stents and defibrillators struggle for growth as a result of pricing pressures and a dip in market share. Companies are looking to cope by expanding their product portfolios through innovative products or strategic acquisitions, according to Zack's. For example, in the fall, Medtronic got a regulatory win in the U.S. for its Assurant cobalt chromium balloon-expanded iliac stent system, and in August, Covidien ($COV) started enrolling patients in two stent trials, as MassDevice notes.