Biotronik has reported positive six-month results of Pulsar stent system form 4EVER clinical study.
The multicenter, single-arm study, which enrolled 120 patients, was designed to assess the safety and efficacy of Pulsar system in superficial femoral artery (SFA) patients.
Results demonstrated convincing evidence of benefits of device performance, patency rates in lower limb intervention on a 4F platform.
The study was also initiated to investigate the feasibility of treating patients with 4F devices from the company’s Fortress 4F sheath, together with the Astron Pulsar and Pulsar-18 SE stents.
Biotronik vascular intervention sales and marketing vice president Alain Aimonetti said results using 4F devices are favorable than compared to 6F devices.
"These six-month results are certainly encouraging and challenge the results from other studies of devices such as Zilver Flex 35 and the RESILIENT study, which both demonstrated a lower value of around 85% primary patency at the same time frame," Aimonetti added
"We are eagerly awaiting the twelve-month results, which we anticipate to show an even greater delta in patency."
The company said the primary endpoint data, primary patency at twelve months, is expected to be unveiled at Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012 in Lisbon, Portugal.