Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular treatments.
According to a news release, the 4-French system may decrease the risk of access site complications and reduce the need for closure devices when compared to 6-French devices. The tri-axial system with the braided shaft facilitates stable and accurate implantation of the Pulsar stent, while the thin struts and low chronic outward force means the Pulsar-18 contributes to a reduced mean area of restenosis.
The company said its redesigned Pulsar-18 T3 stent system offers physicians “an intuitive and ergonomic” wheel-operated handle for one-handed stent release that enhances the ability to control its deployment.
“I was immediately impressed by the new concept of the Pulsar-18 T3 system,” said Dr. Koen Deloose, head of the Department of Vascular Surgery AZSint Blasius Hospital Dendermonde, Belgium. “The combination of having a very ergonomic handle combined with a tri-axial system and also everything in a 4-French concept was, for me, quite unique.”
Despite the new design features, the system still builds on the established performance of Biotronik’s Pulsar stent, with long-term safety and efficiency data showing freedom from target lesion revascularization rate of 89.3% and no major target limb amputations at 24 months.
The Pulsar-18 T3 stent system is indicated for use in improving 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.
Biotronik will offer the stent in up to a 200 mm stent length for treatment of long lesions. The full commercial launch of the device in the U.S. will begin in early August.
“The Pulsar-18 T3 stent system is an innovative solution that delivers clinically proven performance – providing effective therapy that is easy to use for physicians while minimizing metal burden and may reduce the risk of restenosis for patients,” said Biotronik CMO Dr. David Hayes.
