NuVasive Receives FDA Clearance for Expanded Multi-Level Use of CoRoent Small Interlock™ System for the Cervical Spine
SAN DIEGO, Nov. 21, 2019 /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 Company received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system. The expanded indication allows for on-label use of the device at multiple contiguous levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures, compared to other systems on the market cleared for only one- or two-level use. ACDF is a commonly performed surgery to address cervical disc degeneration or spinal instability.
“NuVasive’s expanded indications for use of the CoRoent Small Interlock system represents the first interfixated cervical implant on the market to be cleared for use in more than two level procedures,” said Matt Link, president of NuVasive. “This first-of-its-kind clearance reflects NuVasive’s efforts to further penetrate the cervical market and deliver solutions that address a broader range of spine care.”
The CoRoent Small Interlock system is an anterior cervical interbody fusion system indicated for use in adult patients with cervical disc degeneration and/or cervical spinal instability. The system is a no-profile interfixated device that is implanted entirely within the confines of the vertebral disc space and features a zero-step locking mechanism, a large fusion aperture, angled instrumentation for implantation in difficult anatomical locations and a three-screw implant design allowing for versatile interbody placement.
“The multi-level clearance provides surgeons a zero-profile interbody implant that can be used in more than two contiguous levels, enabling the surgeon to avoid supplemental fixation which can ultimately reduce operative time,” said Leonel Hunt, orthopedic spine surgeon at Hunt Spine in Los Angeles, California.
The receipt of this expanded indication coincides with NuVasive’s presence at the Cervical Spine Research Society (CSRS) 47th Annual Meeting, November 21-23, 2019 at the New York Marriott Marquis in New York City. At booth #307, the Company will showcase its cervical portfolio and host a lunch workshop Cervical Spine Surgery: Why Should I Change? Featuring Advanced Materials Science™.
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology
innovation, focused on transforming spine surgery and beyond with minimally
disruptive, procedurally integrated solutions designed to deliver reproducible
and clinically-proven surgical outcomes. The Company’s portfolio includes
access instruments, implantable hardware, biologics, software systems 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 revenues, NuVasive has approximately
2,600 employees and operates in more than 50 countries serving surgeons,
hospitals and patients. For more information, please visit www.nuvasive.com.
Forward-Looking Statements
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.
CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com;
Media Contact: Jessica Tieszen, NuVasive, Inc., 858-736-0364, media@nuvasive.com
