December 01, 2015
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Greatbatch receives FDA approval for spinal cord stimulation system

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Greatbatch Inc. recently announced it has received FDA approval for its Algovita Spinal Cord Stimulation System to treat chronic intractable pain of the trunk and limbs.

The new spinal cord stimulation (SCS) system is the first FDA-approved product developed by

The QiG Group, a subsidiary of Greatbatch Inc. Greatbatch Inc. is in the process of finalizing the proposed spin-off of QiG Group LLC, which will be renamed Nuvectra Corporation, according to a press release.

“We are excited to receive [premarket approval] PMA approval from the FDA for the Algovita SCS system,” Thomas J. Hook, president and chief executive officer of Greatbatch Inc., said in a press release. “Algovita’s approval not only supports the proposed Nuvectra spin-off, but the system brings to the U.S. market a robust and user-friendly device for patients suffering from chronic pain of the trunk and/or limbs.”

The QiG Group initially will be focused on the commercialization of the Algovita SCS system, which reportedly will be used to treat a variety of neuropathic pain conditions. The Algovita SCS system received a CE mark last year, according to the press release, and is currently in limited release in Europe.

The proposed Nuvectra spin-off is expected to be finalized in the first quarter of 2016.

Reference:

www.greatbatch.com