Biotronik has introduced a new Pulsar-35 self-expanding stent system, designed to reduce target lesion revascularisation in superficial femoral artery (Sfa).
The Pulsar-35 system, which includes the same stent design as Pulsar-18 (0.018"/4F-platform), 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 includes primary patency at 12 months, while secondary endpoints include technical success, time to hemostasis and wound complication rate.
The 120-patient, prospective, nonrandomised, multicentre study’s six-month data showed clinical primary patency rates of 90%, freedom from target lesion revascularisation of 95.4%, technical success of 100% and mean manual compression time of 8.12 minutes.
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, according to the company.
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-diametre-specific distal shaft to provide optimised flexibility in tortuous pedal anatomy.
Biotronik vascular intervention sales and marketing vice president Alain Aimonetti said; "The Pulsar-35 self-expanding Stent and Passeo-14 PTA balloon catheter greatly improve BIOTRONIK’s ability to meet physician needs and deliver best-in-class technology with flexibility for different treatment options."
Image: The new Pulsar-35 self-expanding stent system’s implantion is done to reduce target lesion revascularisation in SFA. Photo: Market Wire.