Bacterin (OTC:BONE) yesterday said it agreed to acquire spinal implant maker X-Spine Systems in a cash-and-stock deal worth about $86 million, including the assumption of debt, and rebrand as Xtant Medical Holdings. Belgrade, Mont.-based Bacterin, which makes allograft products using its in-house tissue bank, said the deal includes $60 million in cash, about 4.24 million Bacterin shares and […]
X-Spine wins FDA clearance for spinal fusion system
X-Spine Systems won an FDA nod for its Zygafix facet fusion system, which stabilizes the facet joint using a hollow titanium compression screw and internal bone graft. The device is approved for patients who have failed traditional non-surgical treatments.
The Miamisburg, Ohio-based company is touting the device as an improvement over the Fixcet, which uses a solid titanium compression screw.
X-spine lands FDA nods for 2 spinal systems
Spinal implants and surgical instrument developer X-spine touted 2 FDA nods for its new spinal systems, which the company plans to include in a launching spree that will take place over the next year.
The next-generation Fortex CoCr system, which features a new cobalt-chromium fixation rod, is designed for the fixation of the thoracic and lumbar spine, particularly in deformity procedures.
BSX touts FDA nod for spinal cord lead | Regulatory Roundup
Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system to control chronic pain.
The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.
Diabetes: FDA clears t:slim portable pump and iglucose management system | Regulatory Roundup
Tandem Diabetes Care and PositiveID (OTC:PSID) landed FDA clearance for their t:slim portable insulin pump and iglucose diabetes management systems, respectively.
St. Jude gets Japanese go-ahead for smallest ICD and CRT in the industry
St. Jude Medical (NYSE:STJ) announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its Fortify implantable cardioverter defibrillator and Unify cardiac resynchronization therapy defibrillator, and the company launched the products in the Japanese market.
A ICD is an device that treats abnormally fast heart rhythms, and a CRT-D resynchronizes beating in the heart’s lower chambers, which often beat out of sync in heart failure patients.
X-Spine wins U.S. regulatory clearance for spinal fusion system
Spinal implants and surgical instrument developer X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to begin selling a spinal fusion system.
The Axle system is designed to provide spinal stability for lumbar fusion procedures, according to the company.
X-spine wins FDA nod for spinal screw system
By Mary Vanac
X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to sell its Fixcet spinal facet screw system.
Fixcet is used to stabilize the spine during spinal fusion procedures, such as treatment of degenerative disk disease, the company said in a press release. Facets are the wing-like bones on the backside of spinal vertebrae.
X-spine Systems licenses spinal cage from Gamma Spine
By Mary Vanac
X-spine Systems Inc., a maker of implants and instruments for spinal surgery, agreed to an exclusive license with Gamma Spine to develop and distribute the minimally invasive spinal fixation technology invented by a professor of orthopedic bioengineering at the University of Toledo.
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