Biotronik's Pulsar-35 Stent and Passeo-14 PTA Balloon Catheter Launched in EU

September 14, 2012—Biotronik, Inc. (Lake Oswego, OR) announced the introduction of the Pulsar-35 (a 0.035-inch, 6-F self-expanding stent platform) and the Passeo-14 percutaneous transluminal angioplasty (PTA) balloon catheter in markets that recognize CE Mark approval.

According to Biotronik, the Pulsar-35 stent features a triaxial delivery system for accuracy of implantation, high multiaxis flexibility, and optimized radial force that is specifically designed for the challenges of superficial femoral artery stenting. It is available in lengths from 30 to 200 mm and diameters of 5 to 7 mm.

The Passeo-14 device is a dedicated 0.014-inch PTA catheter balloon that is available in lengths up to 220 mm. Key features include a stiffened proximal catheter shaft, a hydrophilic coating to aid push transmission and crossability, and a balloon-diameter-specific distal shaft length that provides optimized flexibility in tortuous pedal anatomy.

In October 2011, Biotronik launched the 4-F-compatible Pulsar-18 self-expanding stent system for the treatment of long disease segments in the superficial femoral artery and infrapopliteal arteries on a 0.018-inch, 4-F platform in diameters of 4 to 7 mm with lengths from 20 to 200 mm. The Pulsar-18 completes the company's “4-F solutions” portfolio, which includes the 0.018-inch Cruiser-18 wire, the 4-F Fortress sheath, and the 0.018-inch, 4-F Passeo-18.

According to the company's press release, the safety and efficacy of Pulsar stents in the superficial femoral artery are being evaluated in the 4EVER study. 4EVER is a prospective, nonrandomized, multicenter, 120-patient clinical investigation examining both the acute and long-term performance of 4-F-compatible devices. The primary endpoint is primary patency at 12 months. Secondary endpoints are technical success, time to hemostasis, and wound complication rates.

Full 12-month data from the 4EVER study will be announced at the CIRSE annual congress in Lisbon, Portugal. In January, Principal Investigator Marc Bosiers, MD, presented 6-month data from 4EVER at LINC 2012 in Leipzig, Germany. The 6-month 4EVER data included a primary patency rate of 90%, a freedom from target lesion revascularization rate of 95.4%, a technical success rate of 100%, and a mean manual compression time of 8.12 minutes (with no vascular closure devices used).