Stryker (NYSE:SYK) said today that it won 510(k) clearance from the FDA for its Tritanium PL posterior lumbar cage for lumbar spinal fixation. The Kalamazoo, Mich.-based orthopedics giant said it’s planning on a 2nd-quarter release for the device, made by its Stryker Spine division using a highly porous form of titanium designed to help bone ingrowth. Stryker also […]
Spine
Xtant Medical wins CE Marks for Aranax, Irix-A spine devices
Xtant Medical said today it won CE Mark approval in the European Union for its Aranax cervical plating system and and Irix-A stand alone anterior lumbar fusion device. The company’s Aranax cervical plating system is distributed as a pre-stereilized, ready-to-use implant. The Irix-A stand alone anterior lumbar fusion device consists of an integrated titanium ring […]
InVivo continues the roll, adds another site to Inspire study
InVivo Therapeutics (NSDQ:NVIV) is continuing its momentum, saying today it added another clinical site, this time at the University of Louisville Hospital in Ky., to the Inspire trial testing its neuro-spinal scaffold. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. “I […]
Johnson & Johnson unit inks spine implant development deal with Rainbow Medical
Rainbow Medical said today that it inked a deal with a unit of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes to co-develop a minimally invasive implant to treat degenerative disc disease. The deal between Medos International and Rainbow calls for development work to be carried out both in Israel and the U.S., including pre-clinical trials and laboratory tests, Herzliya, […]
InVivo adds Greenville, N.C. site to Inspire neuro-spinal scaffold study
InVivo Therapeutics (NSDQ:NVIV) said today it added a clinical site at the Vidant Medical Center in Greenville, N.C.to its Inspire study examining the probable benefit of its Neuro-Spinal Scaffold, designed to treat patients with complete thoracic AIS A spinal cord injuries. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to […]
FDA accepts HDE submission from InVivo for Neuro-Spinal scaffold
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its Neuro-Spinal Scaffold. The modular HDE review process is based on individual sections that constitute a complete HDE submission when all have been submitted, and allows for separate review and more timely feedback to aid […]
Stryker launches interbody fusion device
Stryker (NYSE:SYK) today released the Aero-C cervical stability system and cervical interbody fusion device designed for anterior cervical discectomy and fusion procedures. The device was launched at the American Academy of Orthopaedic Surgeons annual meeting in Orlando, Fla. this week. The Aero-C is based on Allendale, N.J-based Stryker’s patented compression technology which features anchor fixation […]
SpineWave licenses Atlas Spine spacer system
Spine Wave said today it is licensing the True Position pivoting spacer system technology from Atlas Spine. The center pivot point technology from the newly licensed True Position spacer allows for more easy and accurate position of interbody spacers, which Spine Wave said will be useful for surgeons implanting “crescent” type devices in a posterior-approach […]
EOS Imaging wins CE Mark for spineEOS
EOS Imaging said today it won CE Mark approval in the European Union for its spineEOS 3D planning software for spinal surgery based on EOS bi-planar imaging. The spineEOS 3D planning sotware is designed to allow surgeons to use 3D-imaging to create optimized treatment plans for improved sagittal alignment for pediatric patients with Adolescent Idiopathic […]
FDA approves InVivo neuro-spinal scaffold trial amendment
InVivo Therapeutics (NSDQ:NVIV) said today the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial. The newly set OPC for the trial is defined as 25% more of the patients in […]
NuVasive loses $42m sales poaching case
A federal jury in California slapped NuVasive Inc. (NSDQ:NUVA) with a $41.8 million judgment after finding that the spinal implant maker poached sales reps from 1 of its distributors. Madsen Medical, a Nevada-based distributor, sued San Diego-based NuVasive in September 2013, after being fired in 2012. Owner Kris Madsen alleged that NuVasive breached its contract when it […]