Mercator MedSystems Announces First Patients Enrolled In U.S. Below The Knee (BTK) Clinical Trial In North Carolina And Texas
EMERYVILLE, Calif., July 27, 2016 -- Mercator MedSystems, Inc., has announced the enrollment of the first critical limb ischemia (CLI) patients in the LIMBO-ATX trial, the design of which was approved by the U.S. Food and Drug Administration (FDA) under an Investigation New Drug (IND) application. The study is designed to measure the benefit of localized drug delivery using the company's proprietary Bullfrog® Micro-Infusion Device in combination with opening obstructed arteries in the lower leg. Patients were enrolled by Dr. George Adams at the University of North Carolina REX Hospital in Raleigh, NC and by Dr. Jason Yoho of the New Braunfels Cardiology Group at Guadalupe Regional Hospital in Seguin, TX, and both enrollments were in conjunction with an atherectomy procedure.
Atherectomy involves the use of intravascular catheter devices to debulk and/or modify plaque in the diseased arteries. While these devices can re-open clogged arteries, they also cause injury and inflammation in the blood vessel wall, which often leads to a re-occlusive scarring process, again limiting blood flow in the artery. The LIMBO-ATX trial involves the local delivery of an anti-inflammatory steroid in an attempt to stop this scar tissue buildup and keep blood flowing. This is similar to giving a cortisone shot into an inflamed joint. By locally extinguishing the inflammation, the biologic signals that normally lead to scar tissue and vessel closure are reduced, potentially keeping the vessel open for a longer period of time after the vascular procedure.
LIMBO-ATX is Mercator's second prospective, randomized, controlled, local drug delivery clinical trial for below-the-knee (BTK) vascular disease. The first study is ongoing in Germany and adds drug locally in combination with balloon angioplasty to BTK arteries. These LIMBO trials are designed to demonstrate that micro-infusion of drug in conjunction with the procedure to re-open the artery will provide much-needed durability, potentially delaying repeat procedures and reducing amputations. There have been struggles with the most recent technologies applied (drug-coated angioplasty balloons) in CLI, and thus there is a significant opportunity to assist these patients in providing them with a better long term therapy.
A total of up to 120 patients are planned to be enrolled in the LIMBO-ATX study over the coming months. Dr. Adams, national co-principal investigator of LIMBO-ATX, commented, "We are very excited to be one of the centers initiating enrollment of the LIMBO-ATX Study. There remains a real need for enhancements in therapy for treating patients with critical limb ischemia, and we hope to show that this therapy can improve patient outcomes and prevent amputation."
Trent Reutiman, CEO of Mercator, noted, "This is a very important step for Mercator. There is an unmet need in delivering a reliable drug therapy to keep arteries open below the knee. Our results from Micro-Infusion in above-knee arteries from our DANCE-Pilot study and our most recent experience from our larger, 285-patient DANCE trial provide us with confidence that the Bullfrog Micro-Infusion Device can efficiently deliver the drug directly where it is needed and that doing so could impact decision making in the daily treatment of critical limb ischemia."
About the LIMBO-ATX Trial:
The LIMBO-ATX Trial is a first-in-class perivascular drug delivery device paired with below-knee atherectomy. The trial leadership includes co-principal investigators George Adams, MD, from University of North Carolina, Rex Medical Center in Raleigh, NC, andDonald Jacobs, MD, from Saint Louis University Hospital in St. Louis, MO. More information about the LIMBO-ATX Trial is available at https://clinicaltrials.gov/ct2/show/NCT02479620.
Mercator MedSystems, Inc., a privately-held Delaware corporation, is a medical device company focused on the clinical and commercial development of a proprietary, FDA-cleared and CE-marked catheter-based drug micro-infusion platform. The design enables the extreme targeting of drugs and/or biologics into tissue around blood vessels or airways to provide localized therapy.
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