BTG Sentry Bioconvertible IVC Filter 2-year Study Results Show Zero Tilt, Migration, Perforation, Fracture, or Embolization
November 7, 2018
BOTHELL, Wash.–(BUSINESS WIRE)–BTG plc (LSE: BTG), the global healthcare company, highlighted the
presentation of the two-year results for the SENTRY trial, at the
Vascular Interventional Advances (VIVA) conference in Las Vegas. The
prospective, multicenter trial of the BTG Sentry, the world’s first
bioconvertible IVC filter, 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.
“This long-term data marks a paradigm shift in pulmonary embolism
protection and is exactly why we brought the BTG Sentry to market,” said
BTG Chief Commercial Officer John Sylvester. “The trial shows no
device-related pulmonary embolism and zero stability complications.
Physicians can have the peace of mind that they are protecting their
patients from the devastating consequences of PE while reducing
complications often associated with IVC filter retrieval. This device
eliminates the need to retrieve and that truly makes it a
next-generation device.”
The findings were presented by principal investigator Dr. Michael D.
Dake. 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 percent 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 percent of patients at 6 months,
96.4 percent at 12 months, and 96.5 percent at 24 months. No IVC
stenosis was reported.
About the BTG Sentry Bioconvertible IVC Filter
The BTG Sentry Bioconvertible IVC filter is designed to provide
protection from 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
conventional IVC filters. U.S. Food and Drug Administration 510(k)
clearance for the Sentry device was obtained in 2017.
About the SENTRY Trial
The SENTRY Trial
is a prospective, single-arm, multicenter registry trial. In the study,
129 patients requiring temporary protection against PE were enrolled at
23 sites in the United States, Europe, and Chile. The 12-month data was
published earlier this year in the Journal of Vascular and
Interventional Radiology.
About BTG
BTG is a global healthcare company focused on Interventional Medicine.
Our innovative medical technology helps physicians treat their patients
through minimally invasive procedures. We have a growing portfolio of
products that advance the treatment of cancer and vascular conditions.
BTG’s Pharmaceuticals business provides products that help patients
overexposed to certain medications or toxins. To learn more about BTG,
please visit: btgplc.com.
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