June 5, 2014 — Mercator MedSystems is in the midst of its prospective, 300-patient, 30-site DANCE (Dexamethasone to the Adventitia to eNhance Clinical Efficacy) clinical trial to study a new therapeutic approach to treating peripheral artery disease (PAD). The trial enrolled its first patient in November 2013, and incorporates the use of Mercator MedSystems’ U.S. Food and Drug Administration (FDA)-cleared Micro-Infusion drug delivery system.
PAD occurs when fatty deposits collect in the peripheral arteries, restricting blood flow and oxygen to the legs and feet. Restricted blood flow results in difficulty with walking, an increased risk of heart attack or stroke, or amputation. Worldwide estimates published in The Lancet estimate the number of people suffering with PAD to be 202 million in 2010, including 17 million Americans.
The DANCE trial is being performed to corroborate results coming from the 20-patient DANCE Pilot, which was performed by Chris Owens, M.D., MSc, at the San Francisco VA Medical Center in California. The primary objective of the DANCE trial is to assess the reduction of inflammation and restenosis in patients with PAD by delivering dexamethasone, an anti-inflammatory steroid, to the adventitia, or outer tissue layer of a blood vessel. National co-principal investigators are Owens and Mahmood Razavi, M.D., of St. Joseph’s Heart and Vascular Center in Orange, Calif. The first procedure was performed by Stuart Harlin, M.D., FACS, at the Coastal Vascular and Interventional Center, in Pensacola, Fla.
Mercator Med Systems is attempting to improve the treatment of PAD by allowing clinicians to accurately and efficiently deliver small volumes of anti-inflammatory drug to the adventitia, which becomes highly inflamed during procedures to open the artery. “Until now, doctors have had to rely on indirect, non-specific methods of controlling inflammation from the inside of the blood vessel. We believe the ‘outside-in’ approach will potentially better target the localized injury caused by vascular procedures such as balloon angioplasty or atherectomy,” said Thomas M. Loarie, CEO of Mercator.
For more information: www.mercator.com