AUDUBON, Pa., April 05, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the launch of two innovative lateral expandable interbody spacers with integrated screw fixation, ELSA® AL and ELSA®-ATP, the latest additions to Globus’ unmatched expandable solutions. These next generation expandable implants provide an optimized fit for the patient, allowing for restoration of sagittal balance and enhanced structural fixation.
Globus Medical is the market leader in expandable interbody spacers with over 20 expandable implant solutions supported by 15 years of clinical experience. Globus Medical’s full line of expandable products has enabled surgeons to treat over 130,000 levels.
“ELSA® AL is the alternative to RISE®-L for selected cases in which maximizing segmental lordosis is indicated,” said Dr. Paul K. Kim, neurosurgeon at Carolina Neurosurgery & Spine Associates. “In conjunction with the ALL (anterior longitudinal ligament) release technique, ELSA® AL has the potential to provide the most amount of segmental lordosis of any device on the market.”
Adjustable Lordosis Technology with ELSA® AL
ELSA® AL’s in situ adjustability and integrated screw fixation are designed to help correct sagittal balance and improve stability. The implant features exclusive adjustable lordotic technology that allows up to 30° of lordosis while maintaining a minimally invasive surgical corridor. With less disruption compared to traditional static spacers, ELSA® AL provides maximum correction and additional fixation for increased segmental stability.
First Expandable Spacer for a Customized ATP Approach
ELSA®-ATP is the only expandable spacer designed to avoid nerve complications associated with the direct lateral technique by using an anterior-to-psoas approach.
The Lateral Lumbar Interbody Fusion (LLIF) technique approaches the spine from the side of the patient, which allows for placement of a larger implant footprint and less disruption of the lower back muscles. The anterior-to-psoas approach is a modified LLIF procedure that avoids the psoas, a large muscle responsible for movement and flexion of the leg. Avoiding this muscle and its integrated nerves may help reduce post-operative complications such as thigh pain.
ELSA®-ATP features angled integrated screws for direct fixation to the adjacent vertebrae. The spacer can be inserted at a minimal height and expanded in situ to minimize tissue disruption and maximize indirect decompression. A full suite of anterolateral access and insertion instruments makes ELSA®-ATP the most comprehensive system on the market.
“Our product development team’s continued commitment to innovation has enabled us to design expandable interbody technology for nearly every surgical approach. The addition of these two unique ELSA® spacers to our expandable lateral portfolio demonstrates our commitment to listening and responding to our customers’ needs through continuous product innovation,” said Andrew Iott, Senior Vice President of Global Product Development. “The use of an expandable spacer for the ATP approach may help reduce complications associated with the lateral procedure. With restoration of alignment being of critical importance, these implants were developed as a tool to help surgeons address sagittal imbalance, with the goal of maximizing lordotic correction.”
Learn more about ELSA® and Globus Medical’s full line of expandable interbody spacers at www.GlobusMedical.com/Expandables.
Indications
The ELSA® Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com
