Orthofix Announces FDA Clearance and First Patient Implant of the 3D-Printed FORZA Titanium TLIF Spacer System with Nanovate Technology
Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced the U.S. Food and Drug Administration 510(k) clearance and first patient implant of the FORZA™ Ti TLIF Spacer System. Developed to help optimize Transforaminal Lumbar Interbody Fusion (TLIF) procedures, the FORZA Ti Spacer with Nanovate™ Technology is a titanium 3D-printed interbody featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer. Interbody implants are spacers that surgeons insert between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs.
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Image of the 3D-printed FORZA Ti Spacer System for TLIF procedures. (Photo: Business Wire)
"The 3D-printed surface technology, titanium material, and implant design all play a role in the bone growth process during fusion," said Gary Rosenberg, D.O., an orthopedic spine surgeon operating at Orange County Global Medical Center in Santa Ana, CA (News - Alert) who performed the first patient implant procedure. "The intuitive instrumentation allows for easy insertion, and the optimized porosity and surface features support our goal of fostering bone growth in order to aid with the patient's fusion."
The FORZA Ti TLIF Spacer System with Nanovate Technology is available in the U.S. through a targeted commercial release.
"Following quickly behind the recent launch of our new cervical interbody, the CONSTRUX™ Mini Ti Spacer System, we are excited to introduce our newest 3D-printed titanium lumbar interbody system," said Orthofix President of Global Spine Kevin Kenny. "The result of our intense focus on bringing solutions to market to meet the current needs of surgeons, the FORZA Ti TLIF Spacer Sstem with our innovative Nanovate Technology will be a key differentiator for surgeons. It will provide access to advanced fusion technology backed by studies that support the proven biological effects of nanoscale features applied to interbody devices."
The FORZA Ti TLIF Spacer System features include:
Featuring Orthofix's unique Nanovate Technology, the FORZA Ti TLIF Spacer System is one of many products with nanotechnology FDA clearance including the recently launched CONSTRUX Mini Ti Spacer System, CONSTRUX Mini PTC Spacer System, the Pillar™ SA PTC Spacer System, and the FORZA™ PTC Spacer System. When compared to solid PEEK devices, the 3D-printed endplates of implants show a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in a more favorable osteogenic environment for bone ingrowth.
*As suggested in an in vivo ovine lumbar spinal fusion model
This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC (News - Alert), which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.
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