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Latest From Elizabeth Orr
On this week’s podcast, senior reporter Elizabeth Orr highlights the most exciting medical device technology coming down the pike as part of the US FDA’s Breakthrough Devices Program.
New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.
Sleep apnea treatment company ResMed Corp. will pay $39.5m to settle allegations that it violated the False Claims Act by giving free or discounted goods and services to distributors and health-care providers to encourage the use of the firm’s devices.
Three patients have filed suit against Medtronic in recent weeks alleging they were injured by malfunctioning surgical staplers made by the company. The lawsuits add to recent scrutiny of the device type’s safety.
A group of manufacturers and clinicians is asking the US agency to allow more discussion between manufacturers, labs and clinicians of how genetic factors could influence drug effectiveness – an area known as pharmacogenomics (PGx). The FDA had previously taken several steps to limit these communications.
The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.