Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after atherectomy-based revascularization) clinical trial. The LIMBO-ATX trial was designed to use Mercator’s proprietary Bullfrog micro-infusion catheter to test a new treatment strategy to potentially improve blood flow and decrease repeat revascularisation procedures in below-the-knee critical limb ischaemia.
“The investigators associated with LIMBO-ATX are very excited to have completed enrolment in this important study. Meaningful results utilising Mercator’s proprietary delivery technique could lead to a change in the standard of care treatment of critical limb ischaemia in the USA,” said George Adams, national co-principal investigator for LIMBO-ATX and director of Cardiovascular and Peripheral Vascular Research at the University of North Carolina, Chapel Hill, USA.
LIMBO-ATX is a prospective, multicentre, randomised, controlled trial that enrolled over 100 patients with arterial obstructions in their below-the-knee arteries. Positive results from the study can be used by the company to seek new indications for the use of Bullfrog to deliver the generic steroid dexamethasone for patients with critical limb ischaemia to improve the outcomes of revascularisation alone.
“The completion of enrolment in LIMBO-ATX is an important step in validating Mercator’s new therapeutic approach to treat critical limb ischaemia disease, and we look forward to seeing the primary six-month endpoint data in the second quarter of 2018,” said Trent Reutiman, CEO of Mercator. “We are encouraged by our investigators’ ability to swiftly complete this study in an area where other technologies have consistently yielded little benefit or have been unable to reach the conclusion of the study.”
Mercator previously sponsored the DANCE trial, which reached its primary endpoint in early 2017 and demonstrated positive patency outcomes from delivering dexamethasone in combination with angioplasty or atherectomy in above-the-knee endovascular revascularisation.
The Mercator Bullfrog micro-infusion device is a FDA 510(k)-cleared and CE-marked system that infuses therapeutic and diagnostic agents directly, non-systemically, and safely through blood vessel walls into adventitial tissues. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection microneedle as it is guided safely through the vascular system to target vessels with diameters of 2mm to 8mm.