Biotronik announced the introduction of a line extension to its 4F compatible, self-expanding stent system dedicated for the treatment of long disease segments in the superficial femoral artery and infrapopliteal arteries.
The new sizes of the Pulsar-18 device mean that it is now available in diameters of 4 mm to 7 mm—suitable for treatment of both superficial femoral artery and below-the-knee (BTK) disease—and lengths from 20 mm up to 200 mm. The stent has an improved radial force, flexibility and fracture-resistance, this is especially important in the superficial femoral artery where stiffer, previous-generation stents have, according to the data, offered only moderate results.
The 4EVER study recently completed its enrolment of 120 patients and will be looking to provide clinical data to support the improved efficacy of this fifth-generation stent design. The results after six months of follow-up are expected to be presented first at The Leipzig Interventional Course, LINC 2012, 25–28 January, 2012.
Available on a 0.018”/4F platform, the new product release completes the “4F solutions” portfolio that the company has created. When used together with the 0.018” Cruiser-18 wire, 4F Fortress sheath and 0.018”/4 F Passeo-18, minimally invasive intervention of the lower limb is now truly possible for short through intermediate and even long lesions. With the ever-increasing interest by physicians to treat more complex and longer lesions, the Pulsar-18 stent system is a single device for all infrainguinal stenting—thus minimising inventory and maximising efficiency.
“Pulsar-18 is the single most important addition to our already developed portfolio for lower limb intervention,” commented Alain Aimonetti, vice president Sales and Marketing at Biotronik. “We believe that the ability to treat patients with 4F low-profile devices will change the future of peripheral intervention. The goal is that patients will be able to have treatment on an outpatient basis and suffer fewer puncture-site complications. Physicians should enjoy higher technical success and lower reintervention rates with this dedicated stent design due to the improved long-term outcomes.”