Peripheral Self-Expanding Stent System Improves Implantation for Endovascular Treatments – Surgical Techniques


Image: The Pulsar-18 T3 self-expanding peripheral stent system has received FDA clearance (photo courtesy of BIOTRONIK)

An innovative self-expanding peripheral stent system is designed to improve implantation procedures for endovascular treatments.

The Pulsar-18 T3 Stent System from BIOTRONIK Inc. (Lake Oswego, OR, USA) uniquely combines three technologies. A low-profile 4-French delivery system may decrease the risk of access site complications and reduce the need for closure devices compared to 6-French devices. The triaxial system with braided shaft facilitates stable and precise implantation of the clinically proven Pulsar stent. With its thin struts and low chronic outward force (COF), the Pulsar-18 stent contributes to a reduced middle zone of restenosis.

The redesigned Pulsar-18 T3 Stent System provides physicians with an intuitive, ergonomic handwheel-operated handle for one-handed stent release, improving the ability to control deployment. Although the stent system has been redesigned with new features to improve deployment, it builds on the established performance of the Pulsar stent. The data highlights the long-term safety and efficacy of the Pulsar Stent, showing no 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 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 of 3 .0 to 6.0 mm and total lesion lengths up to 190 mm. BIOTRONIK will offer the Pulsar-18 T3 up to a stent length of 200 mm for the treatment of long lesions.

“The Pulsar-18 T3 stent system is an innovative solution that offers clinically proven performance – providing an easy-to-use effective therapy for physicians while minimizing metal loading and may reduce the risk of restenosis for patients,” said David Hayes, MD, Chief Physician, BIOTRONIK, Inc.

“I was immediately impressed with the new concept of the Pulsar-18 T3 system,” said Dr. Koen Deloose, Head of Vascular Surgery Department AZSint Blasius Hospital Dendermonde. “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.”

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