First and Only Peripheral Tri-axial 4-French Low-Profile Self-Expanding Stent System Receives FDA Approval

BIOTRONIK Launches its Pulsar-18 T3 Self-Expanding Stent System in the U.S.

LAKE OSWEGO, Oregon and BÜLACH, Switzerland – BIOTRONIK announced that it received U.S. Food and Drug Administration (FDA) approval of its innovative Pulsar®-18 T3 peripheral self-expanding stent system for an improved implantation procedure for endovascular treatments. The company also announced the full U.S. commercial launch of the device, which will begin in early August.

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 devices1. The tri-axial system with braided shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent. With its thin struts and low chronic outward force (COF)2,3,4 the Pulsar-18 stent contributes to a reduced mean area of restenosis3,4.

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.

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

While the stent system has been redesigned with new features to enhance deployment, it builds on the established Pulsar stent performance. 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.5

"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, M.D., Chief Medical Officer, BIOTRONIK, Inc.

BIOTRONIK will offer the Pulsar-18 T3 in up to a 200 mm stent length for treatment of long lesions.

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 3.0 to 6.0 mm and total lesion lengths up to 190 mm**.

References

1 M.Bosiers et al. 4-French-compatible endovascular material is safe and effective in 

  the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial. J

  Endovasc Ther. 2013;20:746-756.

2 BIOTRONIK data on file.

3 Funovics M. Differences in clinical outcomes of low COF stent vs high COF stent proven in clinical practice. BIOFLEX COF, presented at CIRSE, 8.Sep.2019.

4 Zhao HQ et al. Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc Interv Radiol. 2009;32;720-726.

5 Lichtenberg M et al. Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions – the BIOFLEX PEACE all-comers registry. Vasa. 2019;48:425-432.

*Stent-only group 

** For indications please see Instructions For Use.

Pulsar is a trademark or registered trademark of the BIOTRONIK Group of Companies.

BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.