BIOTRONIK is releasing on the international market the Pulsar-18 stent for treatment of long lesions in the superficial femoral and infrapopliteal arteries in patients with peripheral vascular disease. This is the first available 4 F-compatible stent with lengths up to 200 mm.
The Pulsar-18 stent is the next generation of the market-leading Astron Pulsar stent and provides physicians with longer lengths of 100 mm up to 200 mm, optimized radial force and improved flexibility in diameters from 4 mm to 7 mm. The delivery system features an easy to use friction-reducing handle for smooth stent deployment, is compatible with a 0.018-in. guidewire and importantly, a 4F-sheath. The long stent lengths combined with the ultralow profile delivery catheter represent a much-anticipated technology advance.
The Pulsar-18 continues to be studied clinically in multiple trials, including the investigator-initiated 4EVER study, which is evaluating the efficacy of treating SFA lesions with Pulsar-18 and other 4 F-compatible products. The EXPAND study in Europe and Canada compares direct stenting with the Pulsar-18 to PTA with optional bail-out stenting for the treatment of below-the-knee (BTK) lesions.
Development of the Pulsar-18 into lengths from 20 mm to 80 mm is underway.