Greatbatch (NYSE:GB) said yesterday it won FDA premarket approval for its Algovita spinal cord stimulation system for treating chronic intractable pain.
The Algovita system is a rechargeable, 24-electrode spinal cord stimulation system designed to deliver electrical pulses to the dorsal column of the spinal cord to treat intractable chronic pain of the trunk or limbs, the Frisco, Texas-based company said.
“We are excited to receive PMA approval from the FDA for the Algovita SCS system. 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,” CEO Thomas Hook said in an SEC filing.
The Algovita won clearance for indications in the aid of chronic intractable pain including unilateral and bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain, according to an FDA filing.
Greatbatch said the system is the 1st FDA cleared product developed by its QiG Group subsidiary. The company said it is finalizing the spin-off of the QiG group, which will be renamed Nuvectra Corp upon completion.
The Nuvectra spin-off is slated to complete in the 1st quarter of 2016, Greatbatch said.
In late October, Greatbatch said it closed the $1.73 billion, cash-and-stock acquisition of OEM medical device maker Lake Region Medical.
Greatbatch laid out $478 million in cash and some 5.1 million shares of stock (which closed Oct. 27 at $49.27 per share, making that portion of the offer worth another $251 million). Greatbatch said it also agreed to assume $1 billion worth of Wilmington, Mass.-based Lake Region Medical’s debt.
The deal creates an OEM juggernaut in the medical device space, about a year after Lake Region merged with Accellent. The buyout leaves Greatbatch stockholders with about 83.4% of the combined company and Lake Region Medical shareholders with the remaining 16.6%.
