Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes last week reportedly settled with plaintiffs shortly before a Washington state court jury cleared Dr. Jens Chapman and the University of Washington’s Harborview Medical Center in a case filed by the families of a patient who died on the operating table minutes after injection with DePuy Synthes’ Norian XR […]
Spine
InVivo Therapeutics Q2 meets the street, shares stay steady
InVivo Therapeutics (NSDQ:NVIV) shares stayed steady after the company released 2nd quarter earnings that met the street on losses per share. The Cambridge, Mass.-based company reported losses of $5.2 million, or 16¢ per share, for the 3 months ended June 30, 2016. That amounts to a 50% reduction in losses for InVivo Therapeutics compared with same […]
NuVasive wins CMS add-on payment for Magec growth mod system
NuVasive Inc. (NSDQ:NUVA) said today the Centers for Medicare and Medicaid Services granted a new technology add-on payment for magnetically controlled growth rods, including the company’s Magec system. The San Diego, Calif.-based company touted its Magec system as the only magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity. “CMS’s decision will […]
Orthofix wins Japanese regulatory win for Phoenix spinal fixation system
Orthofix (NSDQ:OFIX) said today it won regulatory approval from the Japanese Ministry of Health, Labor and Wellfare for its Phoenix minimally invasive spinal fixation system. The Phoenix system allows for the percutaneous placement of pedicle screws designed to provide stabilization and correction for spinal fusion patients suffering from degenerative disc disease and other conditions, the company […]
Orthofix touts high fusion rates in Trinity Evolution study
Orthofix (NSDQ:OFIX) today announced the publication of a 12-month study which examined the use of its Trinity Evolution cellular bone allograft in patients undergoing vertebral fusions, touting a greater than 90% fusion rate at 12 months The study was published in the European Spine Journal, Lewisville, Texas-based Orthofix said. “We are committed to investing in meaningful […]
Ortho Kinematics launches VMA Align spinal diagnostic module
Ortho Kinematics said today it launched the VMA-Align diagnostic module for its Vertebral Motion Analysis system, designed to provide data to spinal surgeons for patient selection and planning for lumbar fusion surgery. The VMA system from Austin, Texas-based Ortho Kinematics uses fluoroscopy to capture images of the spine in motion, is designed to displace traditional X-ray […]
Stryker’s Q2 numbers top estimates, outlook raised on 2016 sales and earnings
Stryker (NYSE:SYK) shares ticked down in pre-market trading today despite a 2nd consecutive “beat & raise” quarter that saw the medical device giant top both sales and earnings forecasts and boost its outlook on the rest of the year. Kalamazoo, Mich.-based Stryker posted profits of $380 million, or $1 even per share, on sales of $2.84 billion […]
Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate fenestrated screw cement. The company touted the win as the 1st FDA approval for cement-augmented pedicle screws. The newly FDA cleared screw set is indicated for use at […]
Medtronic wins FDA nod for 2-level cervical fusion with Prestige LP spine implant
Medtronic (NYSE:MDT) said today that the FDA approved 2-level cervical fusions using its Prestige LP spinal implant. “Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” Medtronic Spine president Doug King said in prepared remarks. “The Prestige LP Disc is a superior alternative to [anterior cervical discectomy & fusion] and an […]
Medtronic launches new oblique lateral spine tech
Medtronic (NYSE:MDT) said today that it’s launching several new components for its oblique lateral spinal fusion system. Fridley, Minn.-based Medtronic said the Pivox system for its OLIF25 and Divergence-L for the OLIF51 system are slated to debut at the International Meeting on Advanced Spine Techniques in Washington this week. The OLIF procedures are designed to minimize […]
Health Canada OKs trial for InVivo Therapeutics spine scaffold
UPDATED July 14, 2016, with news of 1st Canadian trial site. Just a day after the FDA approved the expansion of the Inspire study of its neuro-spinal scaffold, InVivo Therapeutics (NSDQ:NVIV) said Health Canada granted investigational testing authorization for the study. Today the company said the Toronto Western Hospital’s Research Ethics Board approved its participation in the […]