Biotronik has unveiled a new Pulsar-35 self-expanding stent system to reduce target lesion revascularization in superficial femoral artery (SFA).
The Pulsar-35 system, which includes the same stent design of Pulsar-18 (0.018"/4F-platform) stent system such as high multiaxis flexibility and optimized radial force, features 6F platform technology and a triaxial delivery system to provide precise implantation accuracy.
Pulsar stent technology of 4F-platform was proven to be effective in the 4EVER clinical study, designed to demonstrate the safety and efficacy of Pulsar stents in the SFA.
The primary endpoint include primary patency at 12 months, while secondary endpoints includes technical success, time to hemostasis and wound complication rate.
The 120-patient, prospective, non randomized, multicenter study’s six-month data showed clinical primary patency rates of 90%, freedom from target lesion revascularization of 95.4%, technical success of 100%; and mean manual compression time of 8.12 minutes.
In addition to Pulsar-35 system, the company has added a new product, Passeo-14 balloon infrapopliteal percutaneous transluminal angioplasty (PTA) catheter, to its lower limb portfolio.
The Passeo-14 PTA catheter features a stiffened proximal catheter shaft, hydrophilic coating for excellent push transmission and crossability as well as a balloon-diameter-specific distal shaft length to provide optimized flexibility in tortuous pedal anatomy.
The company said full 12-month data from the 4EVER study will be presented at the CIRSE Annual Congress and Postgraduate Course in Lisbon, Portugal held in September 2012.