Biotronik, a leading manufacturer of cardiovascular medical devices, announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an FDA-approved investigative device exemption (IDE) trial evaluating the use of self-expanding nitinol stents in treating peripheral artery disease. A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at 34 centers in the US, Canada and Europe.
The investigational Pulsar-18 is currently the only self-expanding stent with 4F introducer sheath compatibility for stent diameters of up to 7 mm and lengths of up to 200 mm. It represents a major advance in the minimally invasive treatment of lower limb disease. Pulsar-18 is designed to have high bending and axial flexibility. Its sufficient chronic outward force and crush resistance are intended to support the vessel while minimizing the risk of inflammatory response that can be triggered by excessive chronic outward force.
"The ability to deliver an SFA stent through a 4F sheath expands the possibilities for patient treatment," commented Dr. Carlos Mena, Yale New Haven Hospital, New Haven, Connecticut. Mena is the first US physician to implant a Pulsar-18 stent through a 4F sheath. "The flexible Pulsar-18 has a low crossing profile that is advantageous, allowing use not only through the 4F sheath, but also in tight lesions of the SFA."
Pulsar-18 has CE mark and is sold in over 50 countries globally. The Pulsar-18 and 4F approaches to lower limb interventions were validated in several independent studies, including the 4EVER study, which showed excellent technical success, safety and efficacy for up to two years. In this study, the primary patency of Pulsar-18 was 73.4 percent at 12 months and 69.7 per cent at 24 months. More recently, the Pulsar-18 stent showed 79.5 per cent primary patency 12-month results in the PEACE I all-comers registry.
"Completion of enrollment in the SFA arm of this study represents a major milestone for Biotronik as we strive to bring the full portfolio of Biotronik Vascular Intervention products to the US," explained Dr. Daniel Bühler, president, Biotronik Vascular Intervention.
"Achieving this enrollment goal in the BIOFLEX-I study brings us one step closer to having these novel products available to US physicians for the treatment of lower limb disease," remarked principal investigator Dr Mark W. Burket, University of Toledo Medical Center, Toledo, Ohio. "The Pulsar-18 and Astron stents will give physicians greater opportunity to treat peripheral vascular disease, thereby improving patient quality of life."
Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility - which is believed to contribute to its excellent clinical results. Pulsar-18 comes in diameters of 4 7 mm and lengths of 20-200 mm, all deliverable through a 4F sheath.