BIOFLEX-1 pivotal trial results demonstrate safety and efficacy of Pulsar-18 stent with 4F delivery system

Biotronik’s Pulsar-18 

Biotronik has announced that 12-month data from the BIOFLEX-I study have demonstrated the safety and efficacy of the company’s Pulsar-18 self-expanding stent for blocked superficial femoral artery treatment.

The study results were presented during a late-breaking session at the 2017 Complex Cardiovascular Catheter Therapeutics Advanced Endovascular and Coronary Intervention Global Summit (C3; 29–30 June, Orlando, USA).

In lesion lengths up to 190mm, clinical findings demonstrated:

  • 7% freedom from major adverse events (MAEs) at 30 days
  • 6% freedom from clinically-driven target lesion revascularisation (TLR) at 12 months
  • 8% primary patency at 12 months
  • Clinical follow-up for the prospective, international, multicentre, two-arm investigational device exemption (IDE) trial will be for a total of 36 months

Pulsar-18 is the only superficial femoral artery self-expanding stent approved by the US Food and Drug Administration (FDA) with a 4F delivery system, designed to enable simpler, safer and more efficient procedures than larger diameter delivery systems. Procedure times may be reduced because the system can more easily crosses lesions, lower access site complication rates, and requires less compression time without the need for a closure device.

“Superficial femoral artery blockages are often challenging to navigate and treat because of the length of the artery and frequent presence of diffuse disease. Reduced blood flow to the limb can lead to amputation, so it is critical that patients are treated quickly and effectively,” says BIOFLEX-I US principal investigator, Mark Burket (Toledo, USA). “Because of Pulsar-18’s flexibility, small delivery system and thin struts, the stenting procedure takes less time, reduces complications and allows for earlier patient discharge.”

With low chronic outward force and thin struts (140μm), a press release states that Pulsar-18 may reduce vessel injury and inflammation, provide faster endothelialisation and lower the risk of restenosis. The BIOFLEX-I study found improved clinical and quality of life metrics, including ankle-brachial index (ABI), six-minute walk and walking impairment questionnaire (WIQ).

Pulsar-18 received FDA approval in March 2017 and is available in the USA though Biotronik’s distribution partner Getinge.


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