AUDUBON, Pa., Oct. 25, 2016 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced the introduction of the INDEPENDENCE MIS™ System, an integrated ALIF plate-spacer system designed to simplify implantation and fixation of a commonly challenging procedure.
The INDEPENDENCE MIS™ system features advanced instruments that deploy three pre-loaded anchors through a small protected corridor no larger than the implant itself. Most integrated ALIF systems either use screws, which tend to require a much larger access to insert due to their orientation, or wide blades impacted into the bone that can be hard to retrieve. INDEPENDENCE MIS™ streamlines the anterior procedure into three simple steps: inserting the implant, deploying the anchors, and locking the anchors.
“This device is a game-changer,” commented Andrew Iott, Senior Vice President of Product Development. “It builds on the philosophy and success of the INDEPENDENCE® system by delivering a swift, streamlined procedure that enables surgeons to perform an ALIF in fewer steps while preserving the versatility to use screws. INDEPENDENCE MIS™ is another proud addition to our innovative suite of MIS products.”
Indications
INDEPENDENCE® (including INDEPENDENCE MIS™, INDEPENDENCE® TPS, and INDEPENDENCE MIS™ TPS) Spacers are interbody fusion devices 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). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE MIS™ Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, the INDEPENDENCE MIS™ Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE MIS™ Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant 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: Dan Scavilla Senior Vice President and Chief Financial Officer Phone: (610) 930-1800 Email: investors@globusmedical.com www.globusmedical.com
We can provide sterile packaging as used in our devices so that the product remains sterile until opened in the OR by the operating surgeon. See: http:www.sterilebits.com