September 26, 2017 — The one-year results of the SENTRY clinical trial were presented by principal investigator Michael Dake, M.D., Stanford University, at the VIVA Physicians’ congress, Sept. 11-14 in Las Vegas.
SENTRY is a prospective, single-arm, multi-center registry trial in which the safety and effectiveness of Novate Medical’s Sentry inferior vena cava (IVC) filter, the world’s first bioconvertible IVC filter, was studied. The Sentry is a new generation of IVC filter 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. One hundred twenty-nine patients requiring temporary protection against PE were enrolled across 23 sites in the U.S., Europe and Chile. The rate of new symptomatic PE through 12 months was 0 percent (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 percent (110/115) at six months and 96.4 percent (106/110) at 12 months; this is higher than the majority of published IVC filter retrieval rates.
The Sentry IVC filter received U.S. Food and Drug Administration (FDA) 510(k) clearance in February 2017.
Dake commented, “The SENTRY one-year results are compelling; a 0 percent PE rate and no filter-related complications show that the Sentry IVC filter represents an important new development in the prevention of PE.”
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