FDA Approves St. Jude Medical's Amplatzer PFO Occluder

October 28, 2016—St. Jude Medical, Inc. announced US Food and Drug Administration (FDA) approval and the launch of the Amplatzer patent foramen ovale (PFO) occluder in the United States. The device is designed to help reduce the risk of recurrent ischemic strokes in patients diagnosed with a PFO. With the approval of the Amplatzer PFO occluder, patients in the United States with a PFO who have had an ischemic stroke will now have access to a closure device that has been proven to reduce their risk of recurrent stroke rather than relying on medical management alone, stated the company.

In St. Jude Medical’s announcement, Jeffrey L. Saver, MD, commented, “This is a well-studied therapy with a strong safety profile. Given what we know about the devastating effects of ischemic stroke, the Amplatzer PFO occluder is a compelling treatment option in preventing another stroke for patients with a history of cryptogenic stroke and a PFO who are otherwise young and healthy.” Dr. Saver is director of the stroke center at UCLA and professor of neurology at David Geffen School of Medicine at UCLA in Los Angeles, California.

According to the company, data from the RESPECT trial, an 8-year clinical study of approximately 1,000 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 more than half compared to standard medical treatment. 

In October 2015, long-term results from the RESPECT trial were reported at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held in San Francisco, California.

In St. Jude Medical’s press release, RESPECT lead investigator John D. Carroll, MD, stated, “Interventional cardiology and vascular neurology in major United States 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. The Amplatzer PFO occluder procedure takes less than 1 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.” Dr. Carroll is director of interventional cardiology at the Cardiac and Vascular Center at the University of Colorado Hospital in Aurora, Colorado.

The company noted that in May 2016, an FDA advisory panel, which met to discuss the benefits and risks of the Amplatzer PFO occluder for treatment of recurrent stroke in patients with a PFO, 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 and effectiveness and that the benefits of PFO closure with the Amplatzer PFO occluder outweigh the risks.