BIOTRONIK AG, a leading manufacturer of vascular interventional devices, announced the introduction of a line extension to its popular 4 F compatible, self-expanding stent system dedicated for the treatment of long disease segments in the superficial femoral artery (SFA) and infrapopliteal arteries.
With this launch, BIOTRONIK claims to have surged ahead of its competitors and positioned itself as the only company in the world to offer a complete “4 F solutions” peripheral intervention products package to treat lower limb disease.
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 SFA 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 when compared with competitor devices, as well as the previously successfulAstron Pulsar stent, which it is replacing. This is especially important in the SFA where stiffer, previous-generation stents have, according to the data, offered only moderate results. The 4EVER study recently completed its enrollment 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 atThe Leipzig Interventional Course, LINC 2012, January 25–28, 2012.
Available on a 0.018″/4 F platform, the new product release completes the “4 F solutions” portfolio that the company has created. When used together with the 0.018″ Cruiser-18 wire, 4 F 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 minimizing inventory and maximizing 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 4 F 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.”
“The company is now able to offer guidewires, angioplasty balloons, 4 F introducer sheaths and stents on 4 F,” Aimonetti continued. “The soon-to-be-released drug-eluting balloon will further enhance treatment options available for physicians. BIOTRONIK has stepped up to take and hold the primary position as the partner for physicians treating lower limb disease.”