Thursday, July 2, 2015

News: Globus Medical Announces RISE-L, an Expandable Lateral Interbody Fusion Device

AUDUBON, Pa.--()--Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, announced the introduction of RISE®-L, a lateral lumbar interbody fusion (LLIF) device and the latest addition to the company’s leading portfolio of expandable spacers.
The LLIF procedure, approaching the spine from the side of the patient, allows for a larger implant footprint, and is less disruptive to lower back muscles as compared other approaches, which may result in less blood loss and faster recovery.

RISE®-L is a vertically expanding LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for fusion potential. The all-titanium implant is designed for up to 7mm of continuous in situ expansion and to provide restorative disc height with proper anatomical fit. Available in multiple sizes, in parallel or lordotic profiles, RISE®-L provides options for surgeons to address proper sagittal balance. A large single graft chamber can be filled with autogenous bone graft material after insertion and expansion to ensure even contact with both vertebral endplates.
“Over the last four years we have continued to build upon our unmatched family of expandable spacers, and I am proud of our product development team with the launch of RISE®-L. This new lateral cage eliminates the need to forcefully impact the cage into the disc space. Our expansion technology allows the RISE®-L cage to be placed in compact form, and expanded for optimal fit, and also includes a large port for easy graft delivery once expanded,” commented Andrew Iott, Senior Vice President of Product Development.
“Having used RISE®-L, I am encouraged by the results in my patients. This novel expandable cage addresses many issues with lumbar fusion devices on the market today. With all the benefits of the lateral approach as well as gentle cage insertion, in situ expandability, and robust lordotic options, RISE®-L offers a customized fit and less endplate disturbance. The implant has a graft chamber that is comparable to non-expandable cages as well as a large backfilling port for inserting additional graft material after expansion. RISE®-L is the most elegant solution for lateral interbody fusion on the market,” commented Kevin S. Cahill, MD, PhD, MPH, Spinal Neurosurgeon at Carolina Neurosurgery & Spine Associates.
Globus Medical has steadily innovated its lateral platform starting with the PATRIOT® TransContinental™ LLIF cage over six years ago by bringing to market several advanced treatment options including the CALIBER®-L expandable cage, InterContinental® plate-spacer, and PLYMOUTH® lateral plate. Each product can be used in conjunction with Globus Medical’s MARS™ and MARS™ 3V retractors.
Indications
The RISE® Spacer is a lumbar 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 RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental 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.

Contacts

Globus Medical, Inc.
Ed Joyce, 610-930-1800

Published at Business Wire

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