[By NBC-1TV E. H Kim]Following the success of BIOTRONIK's Pulsar-18 0.018”/4F-platform self-expanding stent system, the company has now introduced its Pulsar stent technology in a 0.035”/6F platform. With this, BIOTRONIK is offering even more physicians its high qualitative stent technology with its high technical success and encouraging clinical performance.

Pulsar stent technology was proven effective during the 4EVER clinical study, with six-month clinical patency rates of 90%. Results were presented in January 2012 at The Leipzig Interventional Course (LINC), Germany, by principal investigator Dr. Marc Bosiers, Chief of Surgery, AZ Sint Blasius, Dendermonde, Belgium.

The 4EVER study is a prospective, nonrandomized, multicenter, 120-patient clinical investigation that evaluates the safety and efficacy of Pulsar stents in the superficial femoral artery (SFA). It examines both the acute and long-term performance of 4F-compatible devices. The primary endpoint is primary patency at 12 months, with secondary endpoints being technical success, time to hemostasis and wound complication rate.

Six-month highlights from 4EVER study data include: primary patency, 90%; freedom from target lesion revascularization (TLR), 95.4%; technical success, 100%; and mean manual compression time, 8.12 minutes (no vascular closure devices used).

The promising 4EVER study data demonstrate the high technical success possible with 4F intervention and the encouraging clinical performance of BIOTRONIK's Pulsar stent systems. Full 12-month data from the 4EVER study will be announced at the CIRSE Annual Congress and Postgraduate Course (CIRSE 2012) in Lisbon, Portugal, in September 2012.

The addition of the Pulsar-35 self-expanding stent system will make BIOTRONIK's proven stent technology available to even more clinicians offering a convenient platform. The Pulsar-35 features a triaxial delivery system designed to provide precise implantation accuracy, and the system benefits from the same outstanding stent design as the Pulsar-18 -- including features such as high multiaxis flexibility and optimized radial force specifically designed for the challenges of SFA stenting. Available in lengths from 30 mm to 200 mm and diameters of 5 mm to 7 mm, this stent will provide an additional treatment option with promising clinical data.