BUELACH, SWITZERLAND--() May 25, 2012 -- The six-month results from the prospective, multicenter, single-arm 4EVER study demonstrate efficacy and safety of BIOTRONIK's Pulsar Stent System in 120 superficial femoral artery (SFA) patients. Analysis of the 120 patients showed excellent device performance, very promising patency rates and convincing evidence of the benefits of lower limb intervention on a 4F platform. Although only the interim results were presented at the Leipzig Interventional Course (LINC 2012) in Leipzig, Germany, analysis of the full cohort has recently been made available.
The 4EVER study was initiated by Dr. Marc Bosiers, Dendermonde, Belgium, to investigate the efficacy of Pulsar stents and also the feasibility of treating patients with 4F devices from BIOTRONIK -- namely the Fortress 4F sheath, together with the Astron Pulsar and Pulsar-18 SE stents.
In total, 120 patients were recruited into the study. Six-month primary patency is documented as being as high as 90.0%. Average lesion length in the Pulsar-18 subgroup was an impressive 10.5 cm. On the 4F intervention side, Dr. Marc Bosiers presented a complication rate of only 3.3% and a mean manual compression time of around 8 minutes, halving the time experienced when using 6F. “The results using 4F devices are very favorable to that experienced with 6F devices and certainly go a long way toward proving what we have always believed -- 4F Solutions are the future,” commented Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention.
Technical success of 100% clearly supports the possibility for minimally invasive peripheral intervention of the lower limb. When asked during the BIOTRONIK symposium at LINC 2012 whether all patients can be treated with 4F, Dr. Koen Deloose, Dendermonde, Belgium, responded, “4F is sufficient for the majority of endovascular treatments.”
Pulsar-18 stents provide an innovative design of ultrathin nitinol struts coated with PROBIO, a silicone carbide layer that improves the stent's hemocompatibility and biocompatibility, which is believed to contribute to its excellent clinical results. Pulsar-18 is available in diameters of 4-7 mm and 20-200 mm lengths deliverable through a 4F sheath.
“We believe that having a good stent platform is essential before adding any combination therapy, especially in SFA,” added Alain Aimonetti. “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. We are eagerly awaiting the twelve-month results, which we anticipate to show an even greater delta in patency.”
The primary endpoint data, primary patency at twelve months, is expected to be presented at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) 2012 in Lisbon, Portugal.
* Failed percutaneous transluminal angioplasty [PTA] arm of the Zilver® PTX® study.
About BIOTRONIK SE & Co. KG
As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.
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