SPINEART LAUNCHES NEW TI-LIFE TECHNOLOGY 3D TITANIUM INTERBODY DEVICES
Spineart is pleased to announce that it has received CE marking for its new JULIET®Ti lumbar interbody systems.
The JULIET®Ti PO, OL and TL interbody systems are the first range of Titanium interbody implants benefiting from our proprietary Ti-LIFETechnology1.
Ti-LIFETechnology micro-porous scaffold mimics the bone trabecular structure and features interconnected pores of 600 μm to 700 μm and an overall porosity of 70-75% designed to enable cell colonization and promote bone in-growth2.
This technology is based on a unique algorithm associated with a state-of-the-art additive manufacturing process.
The JULIET®Ti PO, OL and TL interbody systems include a full range of sizes to address different anatomies. The smooth bullet-shaped nose, lateral sides and chamfers of the implant are polished to preserve endplates, nerve roots and soft tissues during insertion.
The JULIET®Ti design features an overall reduced density to optimize the imaging performances.
In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.
All Spineart implants, including the entire JULIET®Ti range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
For additional product information and distribution opportunities, please contact us at contact@spineart.com.
1Filed patent
2 Pre-clinical data may not represent clinical results.
In Vivo performance of selective electron beam-melted Ti-&Al-4V structures
Ponader, S et al., 2010
Evaluation of biological properties of electron beam melted Ti6al4V implant with biomimetic coating in vitro and in vivo.
Li, X et al., 2012
Porous titanium-6 aluminium-4 vandium cage has better osseointegration and less micromotion than a poly-ether-ether-ketone cage in sheep vertebral fusion.
Yang, J. et al., 2014
Does impaction of titanium-coated interbody fusion cages into the disc space cause wear debris or delamination?
Annette Kienle, MDa,*, Nicolas Graf, Dipl-Ing (FH)a, Hans-Joachim Wilke, PhDb
Direct three-dimensional morphometric analysis of human cancellous bone: microstructural data from spine, femur, iliac crest, and calcaneus
Tor Hildebrand, Andres Laib, Ralph Müller, Jan Dequeker, Peter Rüegsegger
Journal of bone and mineral research. Volume 14, Number 7, 1999
Porosity of 3D biomaterial scaffolds and osteogenesis
Vassilis Karageorgiou, David Kaplan
Biomaterials 26 (2005) 5474-5491
Chapter 8 – Bone Mechanics
Tony M. Keaveny, Elise F. Morgan, Oscar C. Yeh
Standard handbook of biomedical engineering and design
SPINEART ANNOUNCES PUBLICATION OF CLINICAL DATA FOR ITS BAGUERA®C ARTIFICAL CERVICAL DISC PROSTHESIS
Spineart announced today the results published in the Journal of Spine from a multicenter European prospective registry for the BAGUERA ®C cervical disc prosthesis: Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the BAGUERA ®C Prosthesis as Treatment of Degenerative Cervical Disc Disease(1).
A retrospective analysis of a large range of radiographic parameters was performed by an independent evaluator: 99 patients, treated for symptomatic degenerative disc diseases, by one- or two-level arthroplasty, using a total of 123 BAGUERA® C prostheses were included.
Radiographic images at the treated and adjacent levels, as well at the overall cervical region, were analyzed.
The results, 2 years after treatment by arthroplasty using BAGUERA® C, demonstrate good mobility at the treated and adjacent levels, disc height restoration and clear evidence of adjacent levels preservation. There were no signs of subsidence of the prostheses. Measures at the adjacent levels showed no signs of degeneration or kyphosis. Occurrence of heterotopic ossifications was considered low compared to data published by independent evaluators for other disc prosthesis.
The publication further established cervical arthroplasty using the BAGUERA®C disc prosthesis as a safe, effective and motion preserving surgical treatment. The author also considered the results encouraging in terms of adjacent level disease protection.
So far, more than 15’000 BAGUERA® C disc prosthesis have been implanted successfully worldwide. The first surgery was performed in France in January 2007.
This implant is not available in the USA. For more information, please contact us at contact@spineart.com
(1) «Radiographic Outcome and Adjacent Segment Evaluation Two Years after Cervical Disc Replacement with the Baguera®C Prosthesis as Treatment of Degenerative Cervical Disc Disease». Fransen et al., J Spine 2016, 5:2 (Journal of Spine ISSN: 2165-7939) http://www.omicsgroup.org/journals/spine-abstract.php?abstract_id=71753
15 000 BAGUERA®C IMPLANTED
Spineart is pleased to announce that, as of the 1st of June 2016, more than 15’000 BAGUERA® C have been successfully implanted worldwide. The first surgery was held in France in January 2007.
The success of BAGUERA® C can be attributed to the implant’s key features which are its anatomical shape, shock-absorption, guided mobile nucleus and MRI compatibility.
All Spineart implants are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.
This implant is not available in the USA. For more information, please contact us at contact@spineart.com
INTERNATIONAL COURSE IN SAN DIEGO
The Education Department is pleased to announce that another International course was successfully completed on February 26th and 27th in San Diego, USA.
The course was focused on degenerative cervical disc diseases and minimal invasive techniques with 16 attendees and 4 faculty members from 6 different countries.
ANNOUNCEMENT OF FDA APPROVAL PERLA®
Spineart announces that it has recently received 510(k) clearance from the U.S. FDA to market the PERLA® posterior cervico-thoracic fixation system. The system is intended for stabilization of spinal segments as an adjunct to fusion of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3). PERLA® features a comprehensive implant range including preferred angle lateral mass and smooth shank screws, as well as nine different types of connectors for greater flexibility intraoperatively. Transitional rods (CoCr or Titanium) are available to extend the construct to the lumbar spine. In accordance with the Spineart philosophy, the instrument set is ultra-compact and features multi-functional instruments.
All Spineart implants, including the entire PERLA® range, are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency. For additional product information and distribution opportunities, please contact us at contact@spineart.us.
FIRST BAGUERA® SURGERY PERFORMED AT THE CAYMAN ISLANDS
The BAGUERA®- C cervical disc replacement has now been performed on two patients in the Cayman Islands by Drs. Lowell Stanley and Matthew Philips. Dr. Stanley is a graduate of the University of Kentucky Medical School and trained in neurosurgery at University of Texas Southwestern Medical School. Dr. Philips graduated from Yale University School of Medicine and completed his residency and spine fellowship at The University of Pennsylvania. The surgeries were performed at the Georgetown Hospital in conjunction with Cayman Brain and Spine and the Cayman Spine Centre, a state of the art facility dedicated to the treatment of spine conditions with particular focus on cervical surgical conditions.
Since 2007, more than 13.500 BAGUERA® C have been implanted successfully worldwide. The success of the BAGUERA® C can be attributed to its main key features such as its anatomical shape, shock-absorption, guided mobile nucleus and MRI compatibility.
All Spineart implants are sterile packed and barcoded for increased safety, procedure compliance and cost-efficiency.