Newly presented study findings offer support for Novate Medical’s Sentry IVC filter.
Background
The SENTRY clinical trial results were presented at the 15th Annual Conference on Vascular Interventional Advances (VIVA17), which has been taking place in in Las Vegas, NV, by Principal Investigator, Michael Dake MD (Stanford Uni, Ca).
SENTRY is a prospective, single-arm, multi-centre registry trial in which the safety and effectiveness of the world’s first bioconvertible inferior vena cava (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. 129 patients requiring temporary protection against PE were enrolled across 23 sites in the US, Europe and Chile. 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; this is higher than the majority of published IVC filter retrieval rates. The Sentry IVC filter received U.S. FDA510(k) clearance in February 2017.
Investigator comments
Dr Dake commented “The SENTRY 1yr 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.”
Company comments
Paul Bateman, Novate’s CEO added “We are enormously grateful to Dr Dake and all of the SENTRY investigational teams for their contribution to such a significant study. These data for this new generation of IVC filter marks a paradigm shift in the prevention of PE”
Source: Novate Medical
published: September 12, 2017 in: Cardio, Clinical Studies/Trials, Congresses and Meetings, Thoracic/Respiratory