SAN DIEGO, Nov. 18, 2020 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the commercial launch of Cohere® XLIF®, the first Porous PEEK™ interbody brought to market for use in eXtreme Lateral Interbody Fusion (XLIF) and X360™ surgeries. Cohere XLIF is a key addition to NuVasive's Advanced Materials Science™ (AMS) implant portfolio, consisting of proprietary surface and structural technologies, and is designed for bone in-growth while maintaining the imaging and mechanical properties favored in smooth PEEK and titanium coated PEEK interbody devices.
In conjunction, the Company also announced the commercial launch of the Cohere XLIF AMS plate, a low profile anti-migration plate that allows for up to two points of fixation. The plate provides an additional solution at the discretion of the surgeon, particularly in multi-stage procedures, that can be placed before or after insertion of the Cohere XLIF interbody.
"Cohere XLIF provides surgeons with a porous-surface implant designed to promote stability and improved early fusion rates over smooth PEEK and allograft," said Sanjay Khurana, spine surgeon at LA Spine and Orthopedic Institute in Los Angeles, California. "Combined with Cohere XLIF, the Cohere XLIF AMS plate equips surgeons with additional technology when pathologic features call for it and gives confidence in a patient's path to returning to normal activities."
The Porous PEEK technology in Cohere XLIF has been recently studied head to head in cervical spine fusion against smooth PEEK and structural allograft bone. Patients treated with Porous PEEK had significant improvements in disability index and pain scores as early as six weeks post-operatively, compared to those treated with the standard implants.1 Highlights of the Cohere XLIF technology include:
- Cellular Response: As shown in in-vitro studies, Porous PEEK elicits a significantly enhanced osteogenic cell response compared to smooth PEEK and titanium-coated PEEK.2
- Osseointegration: Porous PEEK supports improved implant stability through bone in-growth and has demonstrated greater than three times the integration strength of smooth solid PEEK and titanium-coated PEEK implants in preclinical testing.2
- Durability: Porous PEEK implants maintain high porosity under conditions that replicate clinical loading and resist abrasion damage and delamination under impacted insertion conditions.3,4
- Stiffness: With material stiffness similar to bone, Porous PEEK implants reduce stress shielding and the associated risk of subsidence, compared with stiffer titanium implants.5
"NuVasive's Cohere XLIF implant is another example of how we are combining expertise in lateral implant design with our clinically validated porous surface technology," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "These new offerings strengthen NuVasive's AMS portfolio and equip surgeons with best-in-class technology that procedurally integrate with XLIF and X360 procedures to enable better patient outcomes in spine surgery."
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company's less invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company's comprehensive procedural portfolio includes access, implants and fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,800 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company's surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA® platform), the Company's ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
1Hill CP, Strenge KB. Early clinical outcomes comparing porous PEEK, smooth PEEK, and structural allograft interbody devices for anterior cervical discectomy and fusion. J Spine Neurosurg 2019;8(1):1-7.
2Torstrick FB, Lin ASP, Gall K, et al. Porous PEEK improves the bone-implant interface compared to plasma-sprayed titanium coating on PEEK. Biomaterials 2018;185:106-16.
3Evans NT, Torstrick FB, Safranski DL, et al. Local deformation behavior of surface porous polyether-ether-ketone. J Mech Behav Biomed Mater 2017;65:522-32.
4Torstrick FB, Klosterhoff BS, Westerlund LE, et al. Impaction durability of porous polyether-ether-ketone (PEEK) and titanium-coated PEEK interbody fusion devices. Spine J 2018;18:857-65.
5Carpenter RD, Klosterhoff BS, Torstrick FB, et al. Effect of porous orthopaedic implant material and structure on load sharing with simulated bone ingrowth: A finite element analysis comparing titanium and PEEK. J Mech Behav Biomed Mater 2018;80:68-76.
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SOURCE NuVasive, Inc.
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