BTG, the parent company of Bothell medical-devices manufacturer EKOS, announced this week that the first patients outside of a clinical trial have been successfully implanted with the company’s Sentry device.
The device, a bioconvertible inferior vena cava (IVC) filter, is used to temporarily protect high-risk patients from having a pulmonary embolism — a blockage of one of the pulmonary arteries in the lungs.
According to the Center for Disease Control, as many as 900,000 people could be affected by pulmonary embolisms in the U.S. each year. Between 60,000 and 100,000 Americans die of the condition annually, and approximately 25 percent of those people experience sudden death.
Commercially available IVC filters have, up to this point, fallen into two categories: permanent or retrievable. Both kinds of devices come with certain risks, including filter fracture or migration, recurrent pulmonary embolism, or complications with retrieval.
The Sentry filter does not belong to either category, and according to BTG, it is the first of its kind. The device is made from a bioabsorbable material that after about 60 days, “bioconverts,” or gets converted into usable energy. The patient is then left with an open artery and the device does not need to be retrieved.
“Traditional IVC filters are sometimes associated with a variety of concerns. Placing the BTG Sentry filter gives me confidence in reducing potential complications seen with conventional filters,” said Dr. Ayad K.M. Agha, director of interventional radiology at the Cardiovascular Interventional Radiology Centers in Phoenix, who implanted the device into one of his patients. “Using the BTG Sentry IVC filter only requires one visit which means my patient doesn’t have to worry about coming back to make sure the filter is retrieved. This is better for the patient and their families and removes the risk of any complications that may arise on a follow up procedure.”
“We are excited to see this novel filter now available for patients and are confident that it will make a real difference in the management of (pulmonary embolism) – much like what we have seen in our Sentry trial data,” said John Sylvester, chief commercial officer for BTG.
During the clinical trial, which concluded in September, 129 patients were implanted with the IVC filter. Details and results can be seen here.