Biotronik’s Pulsar-18 T3 Tri-Axial 4-F Self-Expanding Stent System Approved by FDA

July 26, 2022—Biotronik announced that it received FDA approval for the Pulsar-18 T3 peripheral self-expanding stent system, which is designed to provide an improved implantation procedure for endovascular treatments.

The Pulsar-18 T3 stent system is indicated for 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 to 6 mm and total lesion lengths up to 190 mm.

The company stated the full commercial launch of the device in the United States will begin in early August. Biotronik will offer the Pulsar-18 T3 stent in lengths up to 200 mm for treatment of long lesions.

According to Biotronik, the Pulsar-18 T3 stent system combines three technologies:

• A 4-F low-profile delivery system, which may decrease the risk of access site complications and reduce the need for closure devices when compared to 6-F devices.
• A tri-axial system with a braided shaft design that facilitates stable and accurate implantation of the Pulsar stent.
• The Pulsar-18 stent, with thin struts and low chronic outward force, contributes to a reduced mean area of restenosis.

Additionally, the redesigned Pulsar-18 T3 stent system has an intuitive and ergonomic wheel-operated handle for one-handed stent release that enhance the ability to control deployment.

With these new features, it builds on the established Pulsar stent performance. Data demonstrating the long-term safety and efficiency of the Pulsar stent include a freedom from target lesion revascularization rate of 89.3% and no major target limb amputations at 24 months, stated the company.

“I was immediately impressed by the new concept of the Pulsar-18 T3 system,” commented Koen Deloose, MD, in Biotronik’s press release. “The combination of having a very ergonomic handle combined with a tri-axial system and also everything in a 4-F concept was, for me, quite unique.” Dr. Deloose is Head of the Department of Vascular Surgery at AZ Sint Blasius Hospital in Dendermonde, Belgium.