FDA approves Medtronic's new generation of intracranial aneurysm shunting devices

Release date: 2015-02-27

Medtronic announced today that the US Food and Drug Administration (FDA) has approved a new generation of minimally invasive shunts for the treatment of unruptured large or giant cerebral aneurysms.

The company said the catheter's Flex embolization device is suitable for endovascular treatment of complex intracranial aneurysms, which are often not suitable for surgical clipping and are attached to the main vessel, with a diameter of 2.5 to 5.0 mm.

As early as 2011, Medtronic's first generation of minimally invasive shunt devices were approved for use by the FDA in the United States.

The minimally invasive shunt device is designed to transfer blood flow away from an aneurysm. It has a braided cylindrical mesh tube structure that can be placed into the neck and base of the aneurysm. The company explained in a press conference that the device cuts off the blood flowing to the aneurysm and reconstructs the diseased part of the tumor's blood vessels.

“The Flex embolization device is an advancement in the field of shunting. Our clinical proven that its braided design incorporates a new delivery system that provides greater precision and control for the process of implanting the brain.”, President of the Medtronic Neurovascular Group Watt said at the press conference.

"For large or giant wide-necked carotid aneurysms, blood shunting is a breakthrough therapy. These tumors are complex in structure, have a high risk of rupture, and traditional treatments have a high complication rate." From Jacksonville, Florida Dr. Ricardo Hanel, MD, Ph.D., of the Baptist Health Center, added.

Dr. Hanel said that thousands of patients have successfully placed minimally invasive shunt devices, and the new Flex catheter delivery system will be optimized in the field of minimally invasive treatment and care.

Medtronic said the equipment will be available in the next few weeks.

Source: Medical Machinery Innovation Network

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