Patent foramen ovale (PFO) is present in up to 25 percent of the general population. Although it’s asymptomatic for most people with the condition, and most don’t even know they have it, some with PFO can suffer from repeat ischemic strokes. St. Jude Medical won FDA approval to introduce its AMPLATZER PFO Occluder that can help prevent recurrent ischemic strokes by closing the passageway between the atria.
This is the first device to be approved for PFO closure in order to prevent recurrent stroke in the U.S. Previous surgical interventions required open heart procedures, but the AMPLATZER PFO Occluder can be delivered and positioned in a minimally invasive fashion in the cath lab. The patient is kept under conscious sedation and the entire implantation takes less than an hour from start to finish.
More according to St. Jude Medical:
Data from the RESPECT trial, an eight-year clinical study of nearly one thousand patients diagnosed with both PFO and cryptogenic stroke, demonstrated PFO closure provides a clinically meaningful patient benefit over medical management alone, and that PFO closure with the AMPLATZER PFO Occluder reduced the risk of recurrent stroke by over half compared to standard medical treatment.
“Interventional cardiology and vascular neurology in major US and Canadian medical centers have worked together for over a decade to develop the scientific proof from this randomized trial that PFO closure substantially reduces the risk of recurrent stroke in these otherwise healthy patients,” said John D. Carroll, MD, director of interventional cardiology and the Cardiac and Vascular Center at the University of Colorado Hospital. “The Amplatzer PFO Occluder procedure takes less than one hour to complete, can be performed with conscious sedation and subsequently provides these patients with over a 50% reduction of risk for having another stroke for many years to come.”
In May 2016, an FDA advisory panel met to discuss the benefits and risks of the AMPLATZER PFO Occluder for treatment of recurrent stroke in patients with a PFO. The panelists concluded that PFO closure is an important medical therapy and offers clinically meaningful benefits for patients with a PFO who are at risk for recurrent stroke. The panel voted in favor of the device’s safety, effectiveness and that the benefits of PFO closure with the AMPLATZER PFO Occluder outweigh the risks.
Product page: AMPLATZER PFO Occluder…
Via: St. Jude Medical…