Biotronik Pulsar-18 T3 Stent Approved

FDA has approved a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is designed to improve implantation procedures for endovascular treatments. The device features a 4-French low-profile delivery system that is intended to decrease the risk of access site complications and reduce the need for closure devices when compared to 6-French devices, the company says. Its tri-axial system with braided shaft design helps to maintain a stable and accurate implantation of the Pulsar stent, which has thin struts and a low chronic outward force that helps to contribute to a reduced mean area of restenosis, it says. The device is indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0 mm and total lesion lengths up to 190 mm.