Le Lézard
Classified in: Health
Subjects: PDT, FDA, FVT

CarboFix Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System


DOVER, Delaware, Oct. 17, 2019 /PRNewswire/ -- CarboFix has announced today that the U.S. Food and Drug Administration (FDA) has cleared its CarboClear® Carbon Fiber Vertebral Body Replacement (VBR) System to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma.

The CarboClear® VBR System joins the FDA cleared CarboClear® Pedicle Screw and CarboClear® Fenestrated Pedicle Screw Systems.

The CarboClear® VBR implant is made of carbon fibers, with integrated porous Ti-alloy endplates. Carbon fiber implants are proposing unique advantages to the oncological patients and their physicians. Among those advantages are: enhanced radiation therapy planning abilities, allowing radiation treatment to optimize the radiation dose to the tumor with minimal collateral tissue damage, and enhanced follow up abilities due to artifacts-free imaging. In addition, the implants provide unparalleled fatigue strength to support the impaired healing process in those patients, as well as compatibility with particle radiation (proton and carbon ion) and other stereotactic radio-surgery modalities.

Indications for Use: The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

To learn more about the CarboClear® Pedicle Screw System and the new CarboClear® Vertebral Body Replacement (VBR) System, please stop by booth #249 during the CNS 2019 in San Francisco.

About CarboFix

CarboFix is the world leading company in developing, manufacturing and marketing innovative carbon fiber spine and long bones solutions. The company products are cleared by the FDA and other regulatory authorities, and are being sold worldwide.

For more information, please visit www.carbo-fix.com, or contact:
Richard Doucette
VP US Spine Oncology
rick@carbo-fix.com

 

SOURCE CarboFix


These press releases may also interest you

17 jan 2020
Loden Vision Centers, a leading comprehensive ophthalmology company with 5 locations across the greater Nashville and surrounding areas, today announced the appointment of the senior executive, Matthew Pierre, to serve as its Chief Executive Officer....

17 jan 2020
The New Year is traditionally a time for resolutions.  Celebrity lifestyle expert Valerie Greenberg has tips for creating a "new you" for the new year. POPULAR RESOLUTION Have a fitness plan that is easy. One solution is in-home fitness...

17 jan 2020
Alan Alda, the Emmy Award-winning actor, director and writer who has become a leading advocate for effective science communication, has partnered with the renowned scientific institute Scripps Research to bring immersive communication training to...

17 jan 2020
The global PD-1 and PD-L1 inhibitors market is poised to grow by USD 21.2 billion during 2019-2023, progressing at a CAGR of over 19% during the forecast period. Request Free Sample Pages Read the 118-page research report with TOC on "PD-1 and...

17 jan 2020
Therapy and Beyond, a leading provider of autism treatment for individuals, will expand its applied behavior analysis and autism therapy programs to a new location in Sugar Land, TX. About Applied Behavior Analysis Applied Behavior Analysis (ABA...

17 jan 2020
Summary Product: PMS-Nystatin Oral Suspension 100,000 units/mL (DIN 00792667), Lot 681044, Expires 30-11-2021. Issue: Product may contain clumps or jelly-like material, which may lead to choking. Newborns, infants and people with difficulty...



News published on 17 october 2019 at 08:00 and distributed by: