Biotronik has reported positive data from the six-month 4EVER study which evaluated the efficacy and safety of the Pulsar stent system in 120 superficial femoral artery (SFA) patients.
Pulsar-18 stents feature ultrathin nitinol struts coated with Probio, a silicone carbide layer that improves the stent’s hemocompatibility and biocompatibility, which is believed to contribute to the beneficial clinical results.
Available in diametres of 4mm-7mm and lengths of 20mm-200mm, the Pulsar-18 stent is deliverable through a 4F sheath.
The prospective multicentre single-arm 4EVER study was intended to investigate the efficacy of Pulsar stents and the feasibility of treating patients with the company’s 4F devices, namely the Fortress 4F sheath, together with the Astron Pulsar and Pulsar-18 SE stents.
The analysis of the patients in the 4EVER study showed promising Pulsar stent performance, patency rates and convincing evidence of the benefits of lower limb intervention on a 4F platform.
In the study, the six-month primary patency was found to be 90%, and the average lesion length in the Pulsar-18 subgroup was 10.5cm.
During the study, the 4F platform had shown a complication rate of 3.3% and a mean manual compression time of around eight minutes, halving the time of a 6F intervention.
Biotronik Vascular Intervention sales and marketing vice president Alain Aimonetti said the six-month results are encouraging.
"We are eagerly awaiting the twelve-month results, which we anticipate to show an even greater delta in patency," Aimonetti added.
The primary patency data from the twelve-month study is anticipated to be presented at Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012 in Lisbon, Portugal.
Biotronik manufacturers cardiovascular medical devices and provides the solutions for all phases of patient care, ranging from diagnosis to treatment to patient management.
Image: The Pulsar stent from Biotronik had shown efficacy in the 4EVER study. Photo courtesy of: Biotronik.