News | June 05, 2014

Mercator Study to Evaluate the Use of Dexamethasone to Treat Peripheral Artery Disease

National 300-patient study to show effectiveness of adventitial therapy

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:

Related Content

Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Clinical Study | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Clinical Study | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Clinical Study | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Clinical Study | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Clinical Study | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Clinical Study | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init