Enrollment Begins in Mercator MedSystems' TANGO Trial

April 26, 2017—Mercator MedSystems, Inc. announced the first patient enrollment into the TANGO (Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee) clinical trial. This phase 2 perivascular drug delivery trial is being conducted at up to 15 centers in the United States.

TANGO will study the effects of using Mercator’s Bullfrog microinfusion device for adventitial delivery of the drug temsirolimus (Torisel, Pfizer, Inc.) after revascularization of lesions below the knee (BTK) in patients with critical limb ischemia (CLI). The TANGO study was approved by the US Food and Drug Administration (FDA) under an investigational new drug application.

The prospective, multicenter, randomized, dose-escalation trial is recruiting approximately 60 patients with CLI related to arterial obstructions in BTK arteries. In these patients, temsirolimus will be delivered into the tissue immediately around the arterial wall after balloon angioplasty or mechanical atherectomy is used to open the obstructions.

In the company's press release, TANGO's Principal Investigator Ian Cawich, MD, commented, “This is the first clinical trial of its kind. While studies have been done outside the United States with limus-eluting stents in focal lesions in the legs, the local delivery of a limus agent without a permanent implant and in lesions longer than 5 cm has not yet been studied in the United States." Dr. Cawich added, “We are thrilled to be a part of the TANGO study and to be at the forefront of utilizing this novel approach to address the tremendous medical need for an effective CLI treatment.”

According to the company, the Bullfrog microinfusion device has FDA clearance and CE Mark approval for the infusion of therapeutic and diagnostic agents directly and nonsystemically 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 2 to 8 mm.

Use of the Bullfrog delivery system in the TANGO study allows the local delivery of temsirolimus in BTK lesions and eliminates the need to leave behind an implant in the body. The small profile of the Bullfrog device allows it to adjust to small vessels, and it is able to deliver drug volumes that are independent of vessel size, stated the company.