St. Jude, Nonin and AGA Medical win product approvals

St. Jude Libra device for Parkinson's

MINNEAPOLIS, Minnesota –Three Minnesota device companies — including St. Jude Medical — have recently won approval to separately distribute their products in either Australia, the United States or Europe.

The Australian Therapeutic Goods Administration has approved St. Jude’s Libra and LibraXP deep brain stimulation devices that treat symptoms of Parkinson’s disease. The devices, which operate like a pacemaker to stimulate sections of the brain, is already approved for use in Europe and is in clinical trials in the United States for treating depression and Parkinson’s, among other things.

“This approval is an important step forward in bringing our deep brain stimulation systems to a broader market,” Chris Chavez, president of the St. Jude Medical’s neuromodulation division, stated in a media release. St. Jude is based in St. Paul.

In addition, the European Union approved an improved vascular plug made by Plymouth’s AGA Medical. Company executive stated they made the AMPLATZER Vascular Plug 4 to cut the time during an arterial or venous embolization, in which physicians block bleeding in various parts of the body, and cuts down on the number of implants needed to complete the procedure.

Also, Nonin Medical received U.S. Food and Drug Administration clearance for a device that monitors oxygen levels in the brain for patients at risk of ischemia, a lack of blood flow due to tissue damage or other factors. The device, a Model 7600 Regional Oximetry System, measures oxygen levels in the cerebral cortex and removes tissue that can hinder an accurate measurement.