The Pulsar-18 T3 system is a unique combination of three technologies for an improved implantation procedure, a company press release states. The 4F low profile decreases the risk of access site complications and reduces the need for closure devices compared to 6F, while the tri-axial shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent. The intuitive and ergonomic wheel-operated handle simplifies handling during the procedure for physicians.
The superficial femoral artery (SFA) requires a stent that conforms to the natural vessel movement and provides sufficient support in complex and long lesions. The new device unifies proven technologies for efficient delivery of stents up to 200mm to the challenging SFA. The thin struts, low chronic outward force (COF) and high multidirectional flexibility of the Pulsar stent ensure conformability and support to the vessel in all natural vessel movements.
“Pulsar-18 T3 is a unique innovation; this is the first time physicians have access to a self-expanding stent system that combines the benefits of 4F with the accurate deployment of a tri-axial system,” stated Alexander Uhl, senior vice president of Corporate Marketing at Biotronik. “Pulsar-18 T3 represents Biotronik’s dedication to providing effective therapies which minimise burden and reduce risks to patients.”
While introducing the new features to enhance deployment, the new stent system builds on the established Pulsar-18 stent. Recent data highlighted the long term safety and efficiency of Pulsar-18 by showing a freedom from target lesion revascularisation rate of 92.4% at 24 months.
The 4F delivery system offers a number of benefits, including clinically proven lower access site complication rates and a reduced need for closure devices compared to 6F stents. With its low COF and thin struts of 140µm, Pulsar-18 is proven to cause less vessel injury and inflammation, provide faster endothelialisation and lower the risk of restenosis.
Pulsar-18 T3 is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (PTA), e.g. residual stenosis and dissection.