Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US commercial launch of the device, which will begin in early August, according to the company.
Biotronik states that the Pulsar-18 T3 stent system uniquely combines three technologies. A 4 French low-profile delivery system may decrease the risk of access site complications and reduce the need for closure devices when compared to 6 French devices, the company claims. It adds that the triaxial system with braided shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent and, with its thin struts and low chronic outward force (COF), the Pulsar-18 stent contributes to a reduced mean area of restenosis.
The redesigned Pulsar-18 T3 stent system offers physicians an “intuitive and ergonomic” wheel-operated handle for one-handed stent release enhancing the ability to control deployment, according to Biotronik.
“I was immediately impressed by the new concept of the Pulsar-18 T3 system,” said Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). “The combination of having a very ergonomic handle combined with a triaxial system and also everything in a 4 French concept was, for me, quite unique.”
“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,” stated David Hayes, chief medical officer, Biotronik.
Biotronik will offer the Pulsar-18 T3 in up to a 200mm stent length for treatment of long lesions, the company advises.
Biotronik details that 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 from 3–6mm and total lesion lengths up to 190 mm.