FDA approves stroke treatment device

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

New uses for two stroke therapy devices were approved by the FDA Sept. 2, according to a statement by the agency.

The two devices are designed to remove blood clots in ischemic stroke patients. If administered with six hours of the start of stroke symptoms (and only after a clot-dissolving drug), they could help prevent paralysis and speech impairment, according to the statement.

The FDA explained that the device is inserted into the blood vessel where a clot appears through a catheter. The device can grab the clot, and the doctor can pull it back out through the catheter.

The devices’ safety was determined through a 96-person clinical trial that found that 29 percent of patients treated using the removal device had zero to slight disability within three months of a stroke, compared to only 19 percent of patients who were not treated with the device. There are still risks involved: The FDA warned of the possibility of damage to the blood vessels in question through “navigation difficulties” in pulling the clot and device out of the blood vessel through the catheter.

In 2012, the FDA approved the devices, manufactured by the California-based company Trevo, for use in patients who couldn’t tolerate or didn’t respond to clot-dissolving drugs. The new use is the first time such a device has been approved for use in conjunction with the other drugs, according to the of the Director of the Division of Neurological and Physical Medicine Devices at FDA’s Center for Devices and Radiological Health Carlos Peña.

“Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability,” he said in the statement.

That option could help save or prevent severe disability in the 800,000 people a year in the U.S. the experience strokes, according to the Centers for Disease Control.