News | February 28, 2014

New 12-Month Pilot Data Show Clinical Improvement for Patients Suffering With PAD

Pilot findings used to initiate 300-patient prospective, 30-site trial in United States

February 28, 2014 — Mercator MedSystems released pilot study data from a single-arm, open label study of 20 patients suffering with peripheral artery disease (PAD), which reveal sustained, positive clinical outcomes from baseline to 12 months and a one-year primary patency rate of 83 percent. Primary patency (the vessel remaining open) was established by duplex ultrasound measurement and lack of re-intervention to open the vessel. The data was initially released at the 2013 Veith Symposium. Mercator is pioneering peri-adventitial drug delivery that may potentially treat intractable problems associated with some of the world's most significant diseases.

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 pain during walking, increased risk of heart attack or stroke, or amputation. New 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-pilot trial (Dexamethasone delivered to the Adventitia to eNhance Clinical Efficacy) – performed at the San Francisco VA Medical Center – was led by Chris Owens, M.D., MSc., associate professor of vascular and endovascular surgery at the University of California, San Francisco. Fifty-five percent of the 20 patients enrolled in the pilot trial were diabetics and 50 percent had total artery occlusions. The average length of the diseased artery in these patients was 8.9 cm, with most located in the distal superficial femoral or popliteal arteries – the main arteries that provide blood flow to all tissues below the knee. Historically, this region has proven difficult to produce long-term, sustained patency.

Mercator’s U.S. Food and Drug Administration (FDA) cleared Bullfrog micro-infusion device was used to deliver dexamethasone, an off-the-shelf anti-inflammatory steroid to the adventitia, or outer tissue layer of a blood vessel, after another procedure was used to open the arterial obstruction and restore blood flow. Usually, the procedure to open the artery causes vessel injury – which often leads to the formation of scar tissue and re-obstruction of the artery (known as restenosis).

“This study is particularly relevant because it shows that by precisely targeting an injured artery with powerful immuno-modulatory agents, we may be able to alter the body’s aggressive inflammatory response,” said Owens. “With only an additional five to 10 minutes in the catheter lab, we may prevent the restenosis that usually brings these patients back to us within a year.”

Secondary positive patient outcomes included reduction in walking pain and improved blood pressure all the way down to the ankle. No significant adverse effects of the localized drug delivery were noted in these patients.

Mercator is now expanding the DANCE study with a 300-patient, 30-site clinical trial intended to corroborate the preliminary data in the pilot study and further validate localized therapy around blood vessels as a method to treat PAD. The first patient was enrolled in November 2013 at Coastal Vascular and Interventional Center in Pensacola, Fla.

“This is exciting for Mercator because it begins to validate our belief that by delivering commonly available medications to injured vessels, physicians are now empowered to address diseases and conditions that have remained untreated, despite years of advances in the field,” said Kirk Seward, Ph.D., president and chief science and technology officer of Mercator MedSystems.

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