EUROPE – Abbott has launched its Amplatzer Talisman patent foramen ovale (PFO) occlusion system in Europe to treat patients with a PFO who have experienced a stroke and are at risk of having another.
PFO is a hole in the heart that doesn’t close following birth. Nearly one in four people have a PFO, which may allow blood clots to pass from the right side of the heart to the left, from where they can eventually travel to the brain.
For patients who have suffered a stroke, physicians may opt for occlusion (or closure) of the PFO through a minimally invasive, catheter-based procedure using a device like the Talisman system to seal off the opening to reduce the risk of another stroke.
According to the company, the Amplatzer Talisman system builds off the company’s Amplatzer PFO occluder that physicians had to attach to the delivery cable before performing the implant procedure.
Now, the Talisman occluder comes preassembled to the Amplatzer Trevisio delivery cable, reducing preparation time ahead of the procedure and making it easier to use.
The Talisman system accommodates a wide range of patient anatomies and an updated 30-mm occluder size optimizes how it fits in the heart.
The Talisman device is fully recapturable and repositionable so physicians can easily make adjustments for accurate placement, noted Abbott.
Nearly one in four people have a PFO, which may allow blood clots to pass from the right side of the heart to the left, from where they can eventually travel to the brain.
Abbott Park, Illinois-based Abbott’s new Talisman PFO occluders come pre-attached to the delivery cable. This design reduces preparation time for doctors and increases ease of use.
Manchester England-based cardiologist Matthew Daniels completed the first European procedure with Talisman PFO.
“Guidelines from industry organizations and clinical trial data continue to reinforce the benefits of PFO closure for people who have had a PFO-associated stroke,” Daniels said in a news release.
“We’re excited that physicians around Europe now have access to the Talisman device to help reduce patients’ risk and worry of experiencing another stroke.”
Abbott claims that the PFO closure technology has been used to treat more than 180,000 people worldwide and it hasn’t let up on continuing to innovate to best serve physicians and patients.
According to the company, Talisman system simplifies the procedure for doctors and helps patients quickly get back to living fuller, healthier lives.
Talisman earned US Food and Drug Administration (FDA) approval for PFO closure in September 2021.
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