DEXTERITY-AFP Trial Evaluating Mercator’s Bullfrog Device to Treat Inflammation in DVT Enrolls First Patient

November 10, 2021—The first patient was enrolled and treated in the DEXTERITY-AFP phase 2 trial by David Dexter, MD, at Sentara Norfolk General Hospital in Virginia, according to Mercator MedSystems, Inc. The DEXTERITY-AFP trial is evaluating Mercator’s Bullfrog microinfusion device, which is described as a delivery solution designed to address local inflammation associated with treatment for deep vein thrombosis (DVT).

According to the company, the Bullfrog device may help improve outcomes in peripheral vascular intervention for DVT by delivering an anti-inflammatory therapeutic agent directly around the affected vein.

Mercator received investigational new drug approval from FDA for evaluation in two DVT studies, DEXTERITY-AFP and DEXTERITY-SCI. DEXTERITY-AFP is intended to enroll patients with acute femoropopliteal DVT, while DEXTERITY-SCI will enroll patients with subacute or chronic iliofemoral DVT.

“We have long recognized the need for successful and long-lasting outcomes for DVT patients,” commented Dr. Dexter, Principal Investigator of the DEXTERITY-AFP study, in the company’s announcement. “We are delighted to have initiated this important clinical trial for bringing local anti-inflammatory drug delivery to DVT interventions. The goal of this study is to show that local steroid treatment for DVT can address the inherent inflammation associated with DVT and improve the outcomes and durability after mechanical thrombus removal.”

The Bullfrog device uses a balloon that hydraulically deploys a microneedle through the vessel wall into perivascular tissues where the needle can then efficiently infuse drugs or biologics around an artery or vein, stated Mercator. Drug delivery using the device is tracked with x-ray contrast agents.

The Bullfrog device has received CE Mark and is FDA cleared, reported Mercator.