Watertown, Mass., April 16, 2012 – 480 Biomedical announced today that it has initiated the first human trial of its groundbreaking Stanza™ self-expanding bioresorbable scaffold for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). The Stanza™ scaffold restores blood flow to the leg by propping open the diseased artery during the critical healing period, similar to conventional metal stents, but then is resorbed by the body. Observations from the first patients in the STANCE trial were reported on April 14 at the 34th Charing Cross International Symposium in London.
The STANCE trial, a prospective, single-arm, multicenter trial of the Stanza™ scaffold in patients with symptomatic atherosclerotic disease in the SFA, began enrollment in late 2011. 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. At some STANCE sites, the treated vessel will be imaged using optical coherence tomography (OCT), providing a unique opportunity to visualize the scaffold at baseline and as it dissolves over the six to 12-month time period. 480 Biomedical expects to enroll up to 60 patients at sites in New Zealand, Australia and Europe by the end of 2012.
STANCE principal investigator Dr. Andrew Holden, Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine, delivered the presentation at Charing Cross. “We are encouraged by our experience to date with the Stanza™ scaffold system, which has been successfully deployed in the SFA to restore blood flow to the limb in patients with SFA occlusive disease,” said Dr. Holden. “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.”
More than 10 million people worldwide are estimated to have PAD affecting the superficial femoral artery. Individuals with PAD can experience pain and numbness in the legs and feet while walking and at rest, and are at increased risk of heart attack, stroke, limb amputation and death. The Stanza™ scaffold’s unique attributes of mechanical strength, flexibility and biocompatible resorption are ideally suited for treatment in the leg, where complex vessel movement can pose challenges for permanent metal stents including irritation, fracture and difficult-to-treat in-stent restenosis.
“We are excited to be developing this important new treatment option for people suffering from SFA disease, and look forward to reporting additional data from the STANCE trial later this year,” said Duke Collier, CEO of 480 Biomedical. “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.”
480 Biomedical combines deep expertise in materials science with innovative engineering. The Stanza™ bioresorbable SFA scaffold, 480 Biomedical’s lead product, which entered the clinic in 2011, is being developed in both bare and a drug-eluting versions. The company’s resorbable scaffold technology is relevant to a broad range of vascular and non-vascular applications.