Two-year results from BTG’s SENTRY trial paint a positive picture of the company’s bioconvertible inferior vena cava (IVC) filter. The London-based company unveiled the data at the Vascular Intervention Advances conference in Las Vegas.
The prospective, multicenter trial of the BTG Sentry, found that in addition to providing protection against pulmonary embolism (PE) during the transient risk period, the device also had zero instances of tilt, perforation, migration and embolization through two years of imaging-intensive follow-up.
In the long-term data, 85 patients were followed for 24 months using computed tomography (CT) or CT venography imaging. The rate of freedom from new symptomatic PE through 60 days was 100% and there continued to be no cases of device-related new symptomatic PE through 24 months.
There were no instances of filter tilt, migration, embolization, fracture or IVC perforation through 24-months. Two patients developed symptomatic caval thrombosis during the first month, however neither experienced recurrence after successful interventions and no further instances of symptomatic caval thrombosis occurred at 24 months. Filter bioconversion was successful for 95.7% of patients at six months, 96.4% at 12 months, and 96.5% at 24 months. No IVC stenosis was reported.
“The results are very encouraging,” David Hahn, MD, SVP of Medical and Clinical Affairs for BTG, told MD+DI. “What the trial does and the results show, is that we have an extremely promising platform. From this foundation we can now advance to longer-term data. We are looking forward to that, to see the further implications beyond two years.”
BTG picked up the device in September, when it acquired Galway, Ireland-based Novate Medical for about $20 million in cash with an additional $130 million in milestones. The technology has a nod from FDA for the technology.
“[BTG Sentry] is the first of its kind that has a biodegradable element that changes its configuration,” Hahn said.