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Company received FDA OK in June.
October 14, 2013
By: Michael Barbella
The annual meeting of the North American Spine Society (NASS, Oct. 9-12) traditionally is an event where spinal technology companies choose to release new products. At this year’s NASS event, Providence Medical Technology Inc. (PMT) was no exception. The company launched its PMT Cervical Cage in the U.S. market. During the fourth quarter of this year, the company will conduct a limited release of PMT Cervical Cage in preparation for a full release at the beginning of 2014. The PMT Cervical Gage received U.S. Food and Drug Administration 510(k) clearance in June. Privately held Providence Medical Technology develops minimally invasive solutions for cervical fusion. The company’s primary product line, its DTRAX platform of cervical devices, is designed to provide indirect decompression and fusion in patients suffering from cervical radiculopathy (a condition caused by compression of a nerve in the spine) secondary to degenerative disc disease. The company’s current U.S. product portfolio includes the DTRAX Spinal System, DTRAX Graft, and PMT Bone Screws. The PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system. “We are excited to bring indirect decompression and fusion to the cervical market,” said Jeff Smith, co-founder and CEO of San Francisco, Calif.-based Providence Medical Technology. “Our portfolio of minimally invasive devices offers significant clinical advantages for patients suffering from cervical radiculopathy. NASS represents a critical milestone in the history of Providence, as we will introduce U.S. surgeons to our novel, minimally invasive implants for the first time there. Our launch is already underway. We have trained our initial distributor partners and we will be holding cadaver surgeon training courses during the fourth quarter and throughout 2014.”
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