Sam Brusco, Associate Editor07.26.22
Biotronik has received U.S. Food and Drug Administration (FDA) approval for its Pulsar-18 T3 peripheral self-expanding stent system, which aims to improve the implantation procedure for endovascular treatments. Full U.S. commercial launch will begin in August, according to the company.
Pulsar-18 T3’s 4-French low-profile delivery system can reduce risk of access site complications and lower the need for closure devices as compared to 6-French devices. The tri-axial system with braided shaft can facilitate stable, accurate Pulsar stent implantation. With thin struts and low chronic outward force, the Pulsar-18 stent help reduce the mean area of restenosis, as well.
An intuitive and ergonomic wheel-operated handle also allows one-handed stent release.
"I was immediately impressed by the new concept of the Pulsar-18 T3 system," Dr. Koen Deloose, Head of the Department of Vascular Surgery AZSint Blasius Hospital told the press. "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."
Data highlights the long-term safety and efficiency of the Pulsar stent, 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 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, MD, chief medical officer of Biotronik.
Pulsar-18 T3 will be available in up to a 200mm stent length for treatment of long lesions.
Pulsar-18 T3’s 4-French low-profile delivery system can reduce risk of access site complications and lower the need for closure devices as compared to 6-French devices. The tri-axial system with braided shaft can facilitate stable, accurate Pulsar stent implantation. With thin struts and low chronic outward force, the Pulsar-18 stent help reduce the mean area of restenosis, as well.
An intuitive and ergonomic wheel-operated handle also allows one-handed stent release.
"I was immediately impressed by the new concept of the Pulsar-18 T3 system," Dr. Koen Deloose, Head of the Department of Vascular Surgery AZSint Blasius Hospital told the press. "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."
Data highlights the long-term safety and efficiency of the Pulsar stent, 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 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, MD, chief medical officer of Biotronik.
Pulsar-18 T3 will be available in up to a 200mm stent length for treatment of long lesions.