On October 28, 2016, the Food and Drug Administration approved St. Jude Medical Inc.’s Amplatzer PFO Occluder device. The PFO Occluder is a tool designed for patients who have previously experienced a stroke because of a blood clot passing through a small hole in the heart called the patent foramen ovale, or PFO. The device provides a non-surgical method for doctors to close a PFO. PFOs are found in approximately 25 to 30 percent of Americans, and normally do not cause any health problems. However, for stroke patients, PFOs present a problem. For some stroke patients, the PFO can become a pathway for a blood clot to travel to the brain and block a blood vessel, causing another stroke.
The Amplatzer PFO Occluder is inserted through a catheter that is placed in a leg vein and advanced to the heart where it is then implanted close to the hole in the heart between the top right chamber (right atrium) and the top left chamber (left atrium).
The device had been on the market more than a decade ago under a humanitarian device exemption (HDE). The HDE is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. However, the HDE designation for the Amplatzer PFO Occluder device was voluntarily withdrawn by the manufacturer in 2006 because the target population for the device was greater than 4,000 patients.
By approving the Amplatzer PFO Occluder device, the FDA concluded that the device demonstrated a reasonable assurance of safety and effectiveness through randomized clinical studies. However, adverse effects associated with the device or the implantation procedure include injury to the heart, irregular and/or rapid heart rate (atrial fibrillation), blood clots in the heart, leg or lung, bleeding and stroke.