FDA WITHDRAWING HDES FOR TWO HEART CLOSURE DEVICES

The FDA is withdrawing humanitarian device exemption (HDE) marketing approvals for two heart closure devices, the agency said in a notice Aug. 16.

The two devices, NMT Medical's CardioSEAL STARFlex and AGA Medical's AMPLATZER, are patent foramen ovale occluders -- implantable devices that close holes between the heart's right and left atria. Both manufacturers agreed Aug. 14 to voluntarily withdraw their HDEs effective Oct. 31, the agency said.

The devices had been approved to treat patients with cryptogenic stroke (where the cause is not identified) who have had at least one additional stroke despite treatment, the agency said.

The HDEs are being withdrawn because the number of patients eligible for treatment with the devices is significantly higher than 4,000 patients in the U.S. per year -- the limit normally allowed under the HDE indication.

"The withdrawal does not reflect a device safety issue," NMT Medical said in an Aug. 16 statement.