Biotronik Launches Pulsar-18 Self-Expanding Stent in International Markets

November 10, 2010—Biotronik AG (Bülach, Switzerland) announced the international full market release of the Pulsar-18 stent for use in treating long lesions in the superficial femoral artery (SFA) and infrapopliteal artery.

According to the company, the Pulsar-18 stent is the next generation of Biotronik's Astron Pulsar stent and offers longer lengths of 100 to 200 mm, optimized radial force, and improved flexibility in diameters from 4 to 7 mm. The delivery system features a friction-reducing handle for smooth stent deployment, and it is compatible with 0.018-inch guidewires and 4-F sheaths.

Marc Bosiers, MD, is the primary investigator of the 4EVER study, which is evaluating the efficacy of treating SFA lesions with Pulsar-18 and other 4-F-compatible products.

“Studies comparing the results obtained with 4- and 6-F catheters during coronary angiography via the femoral approach report fewer access complications, lower contrast use, decreased mortality rates, and reduced hospitalization as the most important advantages of 4-F systems,” commented Dr. Bosiers. “Our experience confirms that the same advantages may be expected when using 4-F devices in peripheral arteries. Even with their small crossing profile, these 4-F devices offer the pushability needed for peripheral use.”



In addition to the 4EVER trial, the EXPAND study in Europe and Canada compares direct stenting with the Pulsar-18 to percutaneous transluminal angioplasty with optional bailout stenting for treating below-the-knee lesions, Biotronik stated.