BTG (LON:BTG) touted data last week showing that patients with chronic deep vein thrombosis and post-thrombotic syndrome can be safely and effectively treated with the Ekos device and anti-coagulation drugs.
The study’s protocol is the 1st treatment regimen proven to reduce the symptoms of PTS and demonstrate an improvement in quality of life for patients with DVT.
The 73-patient trial met its primary efficacy endpoint and participants reported experiencing a symptom reduction from “severe” to “borderline mild”. The study also found a 21% improvement in patients’ quality of life.
The team reported 1 bleeding incident and 1 pulmonary embolism, meeting the trial’s safety endpoint.
“With the Access PTS study, BTG is once again demonstrating our commitment to advancing the treatment of VTE patients. Chronic DVT can be both debilitating and life threatening. Until now, most chronic DVT and PTS sufferers had no other treatment options,” Ekos VP & GM Matt Stupfel said in prepared remarks. “The Access PTS data proves that Ekos therapy is a safe and effective option for treating chronic DVT. Ekos is setting the standard for interventional chronic-DVT treatment, getting patients back on their feet and on with their lives.”
BTG’s Ekos system uses ultrasonic waves in combination with thrombolytic drugs to dissolve clots and restore heart function. Lead investigator Dr. Mark Garcia hypothesized that the ultrasound helps the vein become more receptive to intervention.
Garcia told Drug Delivery Business News that in the past, he would try to use a high pressure balloon to treat chronic DVT and often the balloon couldn’t open up fully.
“The Ekos, the ultrasound, would go in overnight and I’d bring it back the next day and with a regular balloon I was able to pop it very easily,” he said.
“Now the real challenge is continuing the study and, probably more so, educating both medicine as well as patients that there are opportunities, there is hope, and there are opportunities to change the course of what these patients have been suffering,” Garcia added.
Years ago, Garcia, a vascular and interventional radiologist, began collecting and reporting data from his own work in the clinic, showing other physicians that patients with chronic DVT were not doomed – that their veins could be re-opened up and that patients were getting better. He was later approached by BTG about working on a study with the company’s Ekos device.
“In all honesty, the way you really make the earth move, boulders move and such is to really gain a buy-in from everybody, right? It’s not just physicians, it’s not just industry, it’s not just the patient community out there. It’s really marrying everybody, including government and 3rd party payers to figure out a way to make the world, these patients, better,” Garcia said. “And hopefully it’s a start to that.”