Boston Scientific Receives FDA OK for New Balloon Catheter; Begins Stent Trial

Boston Scientific received U.S. Food and Drug Administration (FDA) clearance to market a new balloon-style catheter in the United States and European Union.

The Natick, Mass.-based firm said its NC Quantum Apex PTCA Dilation Balloon Catheter is intended for use in coronary angioplasty and stent procedures, which are designed to open arteries that have been blocked by atherosclerosis. The condition can cause strokes or heart attacks.

Boston Scientific officials said the device is available with a variety of balloon diameters and lengths. The company plans to launch the catheter in Europe this week and in the United States in June.

In other product development news, the company has begun a clinical trial for its Promus Element Stent. The stent was approved in Europe with a CE Mark in October and is designed to have more radial strength and flexibility as part of its platinum chromium alloy architecture, according to the company.

The trial, called the Platinum Plus clinical trial, will enroll 3,000 patients through 50 sites located in France, Spain, Germany, Italy and the United Kingdom. Patients will participate in the random trial, receiving either the Promus Element Stent or the Xience Prime Stent. The trial will support Boston Scientific’s efforts for regulatory approval by the U.S. Food and Drug Administration and the Japanese Ministry of Health.