Watertown, Mass., October 10, 2012 – 480 Biomedical announced today that the first twenty-five patients enrolled in its STANCE trial have been successfully implanted with the company’s fully self-expanding, bioresorbable scaffold. Dr. Andrew Holden presented data highlighting the STANCE trial’s pioneering use of Optical Coherence Tomography to prospectively evaluate the performance of 480 Biomedical’s Stanza™ SFA scaffold. The presentation was delivered at the Late-Breaking Clinical Trials session of the 10th Annual Vascular InterVentional Advances (VIVA) Meeting.
“To date, we have seen excellent acute scaffold performance with post-procedural images showing the scaffold well apposed to the vessel wall,” said STANCE trial principal investigator Andrew Holden, MD, Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine. “The potential to effectively treat superficial femoral artery disease without a permanent metallic implant is welcome news for our patients.”
“We are excited to be advancing our Stanza™ scaffold through the clinic, and also to be demonstrating the feasibility and utility of Optical Coherence Tomography imaging for infrainguinal procedures,” said Maria Palasis, Ph.D, Executive Vice President and Chief Technology Officer of 480 Biomedical. “Our goal in the STANCE trial is to establish the mechanical performance of our novel self-expanding bioresorbable scaffold design, and we are very encouraged by the data we have seen so far.”
STANCE is a prospective, single-arm, multi-center First-in-Man trial of the Stanza™ self-expanding bioresorbable scaffold in patients with symptomatic atherosclerotic SFA disease. The trial is being conducted at sites in New Zealand, Australia, Germany and Austria. OCT is being used at three STANCE trial sites to assess Stanza™ scaffold deployment post-procedure, and to visualize tissue coverage and scaffold bioresorption at 6 months in half the sub-study cohort, and at 12 months in the other half. The presentation at VIVA included results from the first eight treated patients at Auckland City Hospital.
More than 10 million people worldwide are estimated to have SFA occlusive disease, a narrowing or obstruction of the arteries in the upper leg that restricts blood flow to the lower extremities. Symptoms of SFA disease include pain and numbness in the legs and feet, and untreated disease can lead to increased risk of heart attack, stroke, amputation and death.
About 480 Biomedical
480 Biomedical combines 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 STANCE trial is evaluating the mechanical integrity of the bare scaffold. The company expects to begin enrolling the First in Man trial for its self-expanding drug-eluting scaffold in the SFA in 2013. In addition, the company’s bioresorbable scaffold technology is relevant to a broad range of other vascular and non-vascular applications.
VIVA Physicians is a not-for-profit physician organization dedicated to advancing the field of vascular medicine and intervention through education and research. Since 2003, VIVA Physicians has held an annual multidisciplinary vascular education conference in Las Vegas, Nevada where recognized experts and attendees from all around the world come to innovative technologies and therapies for vascular disease to improve vascular patient care.