The FDA has approved St Jude Medical’s Amplatzer patent foramen ovale (PFO) occluder device for the prevention of stroke. Announced on 28 October, this clearance precedes a first report investigation of the final long-term outcomes of the RESPECT trial (which evaluated the Amplatzer device) that is due to be presented on 1 November at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October-2 November, Washington, DC, USA).
According to the FDA, the Amplatzer PFO occluder has demonstrated a reasonable assurance of safety and effectiveness. RESPECT compared the safety and efficacy of the device plus anticoagulation with that of anticoagulation alone in 499 participants (with cryptogenic stroke) aged 18 to 60 years old. A FDA press release reports that while the rate of new strokes in both treatment groups was very low, the study found a 50% reduction in the rate of new strokes in participants using the Amplatzer PFO occluder plus anticoagulation compared with participants taking anticoagulation alone.
Bram Zuckerman, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, comments: “The Amplatzer PFO occluder provides a non-surgical method for doctors to close a patent foramen ovale. But as the device labelling 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 patent foramen ovale closure with the device is likely to assist in reducing the risk of a recurrent stroke.”
The Amplatzer is inserted through a catheter that is placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the right atrium and the left atrium. The device had been on the market more than a decade ago under a humanitarian device exemption (HDE), but was voluntarily withdrawn by the manufacturer in 2006 after the FDA concluded that the target population for this device was greater than 4,000 patients and that the device no longer qualified for an HDE approval. For the past 10 years, no FDA-approved heart occluder devices have been on the market specifically indicated to close patent foramen ovale to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke.