Safety and Efficacy of Novate Medical's Sentry Bioconvertible IVC Filter Evaluated at 1 Year
September 12, 2017—Novate Medical Ltd. announced that the 1-year results of the SENTRY clinical trial were presented by Principal Investigator, Michael Dake, MD, at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada.
SENTRY is a prospective, single-arm, multicenter registry trial evaluating the safety and effectiveness of the Novate's bioconvertible inferior vena cava (IVC) filter. The Sentry IVC filter device 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 and addressing the typical filter-related complications of existing IVC filters. Novate Medical, which is based in Ireland, received US Food and Drug Administration 510(k) clearance for the Sentry device in February 2017.
In the study, 129 patients requiring temporary protection against PE were enrolled at 23 sites in the United States, Europe, and Chile.
The company reported that the rate of new symptomatic PE through 12 months was 0% (0/129). There were no instances of filter tilting, migration, embolization, fracture, or IVC perforation through 12 months, and there were no filter-related deaths. The rate of successful filter bioconversion was 95.7% (110/115) at 6 months and 96.4% (106/110) at 12 months.
In Novate Medical's press release, Dr. Dake commented, “The SENTRY 1-year results are compelling; a 0% PE rate and no filter-related complications show that the Sentry IVC filter represents an important new development in the prevention of PE.”