FDA Approves First PFO Occluder From St. Jude Medical
St. Jude Medical’s Amplatzer PFO occluder, which is indicated to reduce the risk of recurrent strokes in eligible patients, is the first device of its kind to be approved for the U.S. market. Despite controversy surrounding the novel technology, an FDA panel decided to green light approval in a 15-1 vote in May.
Patent foramen ovale (PFO), a hole between the right and left atria which fails to close during infancy, often remains undetected for a lifetime but is commonly found in patients who suffer unexplained ischemic stroke. PFO occluder devices offer a minimally invasive alternative surgery to accompany blood-thinning medication, the typical therapy for stroke sufferers with PFO. The device is inserted into the heart via catheter.
St. Jude first marketed the device ten years ago under a humanitarian device exemption (HDE), but the company voluntarily pulled the device from the market when the FDA found the target population for treatment was larger than 4,000 patients, according to Regulatory Affairs Professionals Society (RAPS). Since its introduction, the technology has had fierce advocates and critics, and Larry Biegelson, Wells Fargo analyst, told Star Tribune that PFO-closure devices are “one of the most controversial areas of cardiovascular medicine in the past 10 years.”
In May, the FDA hosted a panel of experts to evaluate evidence for and against PFO occluder devices, and to make a recommendation to the FDA based on its findings. Despite some dissenting voices who argued there was not enough clinical data to support a decision, the panel voted 15-1 that studies of the device showed “reasonable assurance” the device is safe.
“The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO,” said Bram Zuckerman, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health (CDRH), in an FDA press release. “But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of recurrent stroke.”
The Amplatzer was developed by AGA Medical and acquired by St. Jude Medical in 2010 in a deal worth $1.3 billion. The market for the device — depending on rate of adverse events — could total between $200 million and $350 million per year, according to Star Tribune.
In a recent earnings call, St. Jude CEO Michael Rousseau commented that the Amplatzer is the first device of its kind to be approved in the U.S., and is an “important treatment option for patients with a PFO who live at risk and in fear of suffering additional strokes.”
St. Jude Medical is on track to be acquired by Abbott Laboratories by the end of 2016, and Abbott has been restructuring and consolidating its businesses to prepare for integration of St. Jude’s portfolio.