Two-Year Results Presented for BTG's Sentry Bioconvertible IVC Filter

November 7, 2018—BTG plc announced that 2-year results from the SENTRY trial, which evaluated the company's Sentry bioconvertible inferior vena cava (IVC) filter, were presented by Principal Investigator Michael D. Dake, MD, at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.

The Sentry device recently received FDA 510(k) clearance and is designed to provide protection from pulmonary embolism (PE) for the period of transient risk and then bioconvert to leave a patent, unobstructed IVC lumen, obviating the need to retrieve the device.

According to the company, the prospective, single-arm, multicenter registry trial was composed of 129 patients requiring temporary protection against PE. The patients were enrolled at 23 sites in the United States, Europe, and Chile.

At VIVA 2018, Dr. Dake reported that 85 patients were followed for 24 months using CT or CT venographic 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.

Additionally, 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 6 months, 96.4% at 12 months, and 96.5% at 24 months. No IVC stenosis was reported.

The 1-year results of the SENTRY trial were presented at VIVA 2017 and recently published by Dr. Dake et al in Journal of Vascular and Interventional Radiology (2018;29:1350–1361).

The Sentry device was developed by Novate Medical, which BTG acquired in September 2018. BTG plans to launch Sentry in the United States in the second half of the 2018/2019 fiscal year and will sell the device through its existing vascular sales force.