Biotronik reports positive results from BIOFLEX-I trial of Pulsar-18 stent for PAD
German firm Biotronik has reported positive results from the BIOFLEX-I clinical trial of the Pulsar-18 stent to treat patients suffering from peripheral artery disease (PAD).
Pulsar-18 is a superficial femoral artery (SFA) self-expanding stent that features a 4-French (4F) delivery system to allow simple, safe and efficient procedures compared to delivery systems with a larger diameter.
The device also mitigates procedural duration as the 4F system enables easy crossing of lesions, decreasing access site complication rates as well as compression time by eliminating the requirement for a closure device.
Analysis of twelve-month clinical findings from the BIOFLEX-I trial of the stent in lesion lengths of about 190mm showed 66.8% primary patency and 87.6% freedom from clinically driven target lesion revascularisation (TLR) at 12 months with 99.7% freedom from major adverse events (MAEs) at 30 days.
BIOFLEX-I US principal investigator Mark Burket said: "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."
The prospective, international, multi-centre, two-arm investigational device exemption (IDE) trial evaluated the safety and efficacy of Pulsar-18.
Data from the study further indicated improved clinical metrics and quality of life measured as brachial index (ABI), six-minute walk and walking impairment questionnaire (WIQ).
Approved by the US Food and Drug Administration (FDA) in March this year, Pulsar-18 is distributed in the country by the firm’s partner Getinge.