480 Biomedical has started the human trial of its Stanza self-expanding bioresorbable scaffold to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA).
The multicenter, prospective, single-arm Stance trial is designed to study the safety and effectiveness of Stanza self-expanding bioresorbable scaffold.
The primary safety endpoint of the trial is major adverse events at six months.
Secondary performance endpoints include vessel patency at three, six, 12 and 24 months, in addition to several functional and quality-of-life metrics.
480 Biomedical said at some Stance sites, the treated vessel will be imaged using optical coherence tomography (OCT) to visualize the scaffold at baseline as it dissolves over the six to 12-month time period.
Stance principal investigator and Auckland University School of Medicine radiology associate professor Andrew Holden said: "The Stanza scaffold may provide an optimal solution for patients with symptomatic peripheral artery disease; the ability to structurally support the vessel without a permanent metallic implant is potentially a game-changing technology."
480 Biomedical CEO Duke Collier said the company is excited to develop the new treatment option for people suffering from SFA disease, and look forward to report additional data from the Stance trial later in 2012.
"The challenges of the SFA vascular bed provide a rigorous test of our Stanza scaffold platform, which will have applications in many other vessels and lumens in the body," Collier added.
The Stanza scaffold restores blood flow to the leg by propping open the diseased artery during the critical healing period, and then is resorbed by the body.