UK-based healthcare firm BTG has reported positive results from the ACCESS PTS clinical trial of EKOS therapy to treat post-thrombotic syndrome (PTS) in patients suffering from chronic deep vein thrombosis (DVT).
The therapy uses EKOS system that combines ultrasonic waves with clot-dissolving thrombolytic drugs to dissolve clots and restore normal blood flow.
The results showed that the therapy met its primary efficacy endpoint of minimising the signs and symptoms of PTS, as well as a significantly improved quality of life for the patients.
The multi-centre prospective single-arm ACCESS PTS trial evaluated the safety and efficacy of EKOS in 73 iliofemoral DVT patients who met the eligibility criteria and had failed three months of conservative therapy.
During the trial, anticoagulation drugs were administered to the patients before EKOS therapy with balloon dilatation.
EKOS vice-president and general manager Matt Stupfel said: “Chronic DVT can be both debilitating and life threatening. Until now, most chronic DVT and PTS sufferers had no other treatment options.
“The ACCESS PTS data proves that EKOS therapy is a safe and effective option for treating chronic DVT.”
A symptom reduction from severe down to borderline mild, significant improvement of signs at 30 days across 77 limbs of the total patients, and 21% improvement in the quality of life were observed during the trial.
EKOS is believed to be less thrombolytic and result in significantly shorter treatment times, when compared to standard catheter-directed drug therapy, reducing the risk of complication, including bleeding.