Minimally invasive spine market will surpass $842 million by 2023 as technology swiftly develops: GlobalData

Posted On February 2, 2017 By OrthoSpineNews In Financial, Spine /

February 1, 2017 — The minimally invasive spine (MIS) surgery market, which covers 39 markets, will rise from $512.6 million in 2016 to just over $842 million, representing a compound annual growth rate of 7.4%, according to research and consulting firm GlobalData.

The company’s latest report states that this relatively strong growth will be driven by a global shift towards healthcare treatments performed in outpatient facilities, heightened surgeon interest in incorporating MIS surgical approaches in their practices, and a growing interest in surgical navigation and robotics technologies.

Jennifer Ryan, GlobalData’s Analyst covering Medical Devices, explains: “These factors, coupled with the rising prevalence of degenerative spine diseases and advancements in complementary technologies, is propelling the market forward.”

The global MIS market is controlled by three large multinationals with strong brand name recognition: Medtronic, DePuy, and NuVasive. Other top players include Stryker, Globus Medical, and Zimmer Biomet. These six market leaders boast strong overall spine portfolios and wide-ranging distribution networks, and most offer a full orthopedics platform beyond spine and biologics.

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Stryker’s Marc Esformes Discusses Future of Medical Implants at LAM 2017

Posted On February 2, 2017 By OrthoSpineNews In Spine /

ORLANDO, FL (PRWEB) JANUARY 31, 2017

The additive manufacturing revolution is in full swing. With more industries adopting 3D printing capabilities for their parts development, 3D printed materials are here to stay. At the Laser Institute of America 2017 Laser Additive Manufacturing Workshop (LAM®), researchers and industry leaders alike will discuss the state of additive manufacturing, as well as present ongoing developments within the various industries they serve.

Presenting on Day One, during Session One: Trends in Laser Additive Manufacturing, is Marc Esformes of Stryker Corporation, discussing “Additive Manufacturing of Medical Implants.” Stryker Corporation is among the pioneering companies to use additive manufacturing technology to develop medical devices and tools, and recently announced the expansion of their 3D printing capabilities by developing a brand new, multi-million-dollar facility. Their exciting new solution for spinal surgical implants has garnered ample attention, not just in the world of additive manufacturing, but in fields like orthopedics, neurosurgery and general surgery.

Stryker Corporation began as the medical practice of Dr. Homer Stryker. The practice was incorporated as an orthopedic frame company in 1946, before becoming Stryker Corporation following Dr. Stryker’s retirement in 1964. In recent years, Stryker Corporation has become one of the leading companies using additive manufacturing technology to develop parts for the medical field. Unlike other industries, the parts and implants created in the medical industry must go through numerous comprehensive trials and tests for biocompatibility, long before they are used for their intended purpose.

This year, Stryker Corporation developed a 3D printed Tritanium (the brand name of Stryker’s alloy material, used in their powder bed laser sintering process) Posterior Lumbar Cage Spinal Implant. The implant was showcased at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting. Using virtual reality technology, the presentation showed viewers the evolution of Stryker’s manufacturing before giving a virtual tour of the Stryker facility, including a close-up look at the implant. Expanding upon existing implant technology, and over a decade worth of research, the spinal implant is porous, and resembles bone tissue. Given its flexible, permeable state, early trials suggest that the implant may encourage natural bone growth, leading to a longer-lasting, more functional implant, that behaves like natural bone.

Don’t miss your chance to explore the latest advancements in medical additive manufacturing when Marc Esformes of Stryker Corporation presents at LAM 2017. LAM will take place February 21-22, 2017, in Houston, Texas. For more information, and to register, please visit https://www.lia.org/conferences/lam.

The Laser Institute of America (LIA) is the international society for laser applications and safety. Our mission is to foster lasers, laser applications, and laser safety worldwide. http://www.lia.org.

SeaSpine® Announces Full Commercial Launch of Vu a∙POD™ Prime NanoMetalene® System

Posted On February 2, 2017 By OrthoSpineNews In Spine /

CARLSBAD, Calif., Jan. 31, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of its Vu a•POD Prime NanoMetalene System.

The Vu a•POD Prime NanoMetalene System features a zero-profile, standalone anterior lumbar interbody device that can be configured in a variety of footprint and lordosis combinations to accommodate an individual patient’s pathology. The Vu a•POD Prime NanoMetalene System offers multiple fixation options for maximum versatility and adds to SeaSpine’s growing portfolio of offerings featuring proprietary NanoMetalene technology.

“The new lordosis options enable me to better recreate the patient’s natural alignment. These features, particularly when combined with the NanoMetalene technology, should speed the healing process and improve long-term outcomes,” stated Dr. Nilesh Patel, an orthopedic surgeon practicing at Beaumont Hospital in Dearborn, MI.

NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging. NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.

Additionally, Vu a•POD Prime NanoMetalene implants are delivered individually sterile-packaged and ready-to-use. This packaging solution is designed to facilitate configurations tailored to address individual surgeon preferences, while simplifying hospital processing requirements and inventory management.

NanoMetalene, SeaSpine and the SeaSpine logo are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and other countries. Vu a•POD Prime is a trademark of SeaSpine Orthopedics Corporation or its subsidiaries. PEEK-OPTIMA is a registered trademark of Invibio and is used by SeaSpine under license.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal fusion hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes and cellular grafts that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal fusion hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development allows SeaSpine to offer our surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the versatility of the Vu a•POD Prime NanoMetalene System; its ability to better recreate patient anatomy; the benefits of NanoMetalene technology and products; the benefits of sterile-packaged products; and whether new lordosis options, alone or when combined with NanoMetalene, will speed the healing process and improve long-term outcomes. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products; the ability of newly launched products, including the Vu a•POD Prime NanoMetalene System, to perform as designed and to meet clinical needs when implanted in patients; the lack of clinical validation of newly launched products, including the Vu a•POD Prime NanoMetalene System; the Company’s ability to invest adequately in the commercialization of its products, including new products such as the Vu a•POD Prime NanoMetalene System, and the risk of excess inventory in the event demand for new products is less than the Company’s expectations; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; other difficulties and delays in launching new products; the inability to apply NanoMetalene technology consistently and reproducibly; the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact 
Lynn Pieper
(415) 513-1281
ir@seaspine.com

ChoiceSpine acquires Exactech’s spine assets

Posted On February 1, 2017 By OrthoSpineNews In Spine /

KNOXVILLE, TENN. – February 1, 2017 – ChoiceSpine, a privately held spinal fusion device manufacturer based in Knoxville, Tenn., announced today it has acquired the spinal assets of Exactech (Nasdaq:EXAC). Exactech is a developer and producer of bone and joint restoration products for extremities, hip, knee and spine, with corporate headquarters in Gainesville, Fla.

“This is a great addition to our emerging product line,” said Rick Henson, co-owner of ChoiceSpine. “We look forward to building relationships with Exactech distributors and end users, as well as extending our product offering to potential new customers.”

The acquisition will also have beneficial international implications with Exactech having distribution channels in Spain, Portugal and Germany. “We currently have distribution partners in Italy and Mexico, so these new assets will immediately boost our international footprint,” added Marty Altshuler, co-owner of ChoiceSpine.

“This investment will continue to build the momentum behind our pursuit of becoming a prominent, full-line spinal implant provider.”

In addition to today’s acquisition announcement, ChoiceSpine also announced it would be rolling out several new products this year, along with a complete biologics line, set to complement its expanding implant portfolio.

Founded in 2006, ChoiceSpine now has more than 45 employees and is majority-owned by Henson and Altshuler. For more information on the company, visit choicespine.com.

About ChoiceSpine

ChoiceSpine is a privately held spinal implant company located in Knoxville, Tenn., and prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to the market.

Northwell Health is First on Long Island to Acquire Synaptive Medical’s BrightMatter™ Technology for Complex Brain Tumor and Spinal Surgery

Posted On January 31, 2017 By OrthoSpineNews In Neuro, Spine /

January 31, 2017 – TORONTO–(BUSINESS WIRE)-

Synaptive Medical Inc., a medical device and technology company, is pleased to announce that North Shore University Hospital, a member of Northwell Health, is the first center on Long Island to acquire the BrightMatter technology, an innovative solution of advanced imaging, planning, navigation, and robotics for complex brain tumor and spinal surgery.

“In our efforts to provide our patients with the absolutely latest technology and expertise, Northwell Health’s Neuroscience Institute and Cancer Institute are delighted to introduce Synaptive’s BrightMatter neurosurgical system to our area,” said Raj K. Narayan, MD, Northwell Health’s senior vice president, neurosurgery service line. “Being one of the first centers in the country to adopt this technology, we will now be able to approach tumors in the brain with visualization of details that will enable us to perform safer procedures and provide better outcomes. The system allows neurosurgeons to use sophisticated magnetic resonance imaging (MRI) data to gain insight into the structure of white matter, which can help them locate neural pathways responsible for a patient’s ability to walk, speak, or see. A very kind gift from the estate of a patient, Mr. Irwin Davis, who himself had a brain tumor several years ago, made this advance possible. We are all very grateful, as will be many future patients.”

BrightMatter provides neurosurgeons with the latest advancements in visualization tools to perform minimally-invasive, patient-specific procedures. Using an imaging method called diffusion tensor imaging, or DTI, BrightMatter uses tractography to automatically enhance MRI images of the entire brain’s pathways, allowing surgeons to see structures that can’t be seen with the naked eye and consider approaches for optimal navigation. This functionality may allow access to brain locations previously deemed inoperable.

With this information, surgeons can use Synaptive’s high-powered magnification system to view patient anatomy. This optical visualization system, mounted on a robotic arm, follows the surgeon’s tools and shows patient anatomy in unprecedented detail. BrightMatter allows for better surgical ergonomics, facilitates collaboration with operating room staff, and consumes less surgical time without the need to manipulate cumbersome optics.

“With the addition of this state-of-the-art technology, we will not only offer our patients unique treatment options, but also conduct clinical oncology research for discovery of still better approaches as we go forward,” said George Raptis, MD, Northwell Health’s senior vice president, cancer service line. “This is in step with Northwell Health’s ongoing commitment to all the communities we serve.”

Synaptive is uniquely positioned to support Northwell Health’s commitment to be on the forefront of care through state-of-the-art technologies and innovative research. “Collaborating with surgeons to better understand their challenges in the operating room is deeply rooted in Synaptive’s culture,” said Cameron Piron, Synaptive’s president. “Their insights fuel our development work and help our engineering teams to design integrated solutions, both for today and for operating rooms of the future. We look forward to exploring new opportunities with Northwell Health’s neurosurgical team.”

About Northwell Health

Northwell Health is New York State’s largest health care provider and private employer, with 21 hospitals and over 550 outpatient facilities. We care for more than two million people annually in the metro New York area and beyond, thanks to philanthropic support from our communities. Our 61,000 employees – 15,000+ nurses and nearly 3,400 physicians, including nearly 2,700 members of Northwell Health Physician Partners — are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institute. We’re training the next generation of medical professionals at the visionary Hofstra Northwell School of Medicine and the School of Graduate Nursing and Physician Assistant Studies. And we offer health insurance through CareConnect. For information on our more than 100 medical specialties, visit Northwell.edu.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170131005866/en/

SpinalCyte, LLC Enrolls First Patient in Landmark Phase I Human Clinical Trial

Posted On January 27, 2017 By OrthoSpineNews In Spine /

January 26, 2017

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on the regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today the enrollment of its first patient in a study for the development of CybroCell, the first dermal fibroblast cell product for treatment of degenerative disc disease.

“This unprecedented study marks the first time a human patient will receive dermal fibroblasts for treatment of degenerative disc disease,” said SpinalCyte Chief Executive Officer Pete O’Heeron. “Our preclinical trials resulted in significant regrowth of the spinal disc nucleus, increases in disc height, and gene expression such as proteoglycan. This could be the beginning of a new wave of cell-based treatments for degenerative disc disease, in lieu of surgery.”

The clinical trial will enroll 18 patients between the ages of 18 and 85. Each patient will be administered CybroCell alone, in combination with platelet-rich plasma (PRP), or saline only. The measurable outcomes of the study will take 12 months. SpinalCyte aims to show that using its allogenic “prepackaged” cell therapy product will lead to a reduction in pain, improved function, and regeneration of damaged discs.

“We are excited about the potential of this new technology to treat degenerative disc disease,” said Carlos Manuel Ruiz Macias, M.D., Principal Investigator of the SpinalCyte clinical trials. “We believe that regenerative cell therapy is the future of medicine, and the life-changing opportunities that lie ahead could have enormous impact on the millions around the world who deal with back pain and problems due to injury, age, or other factors.”

To learn more about SpinalCyte, LLC, please visit www.spinalcyte.com.

About SpinalCyte, LLC

Based in Houston, Texas, SpinalCyte, LLC is a tissue engineering technology company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 12 U.S. and international issued patents, and has filed for an additional 40 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement.

Contacts

Investor Contact:
SpinalCyte, LLC
Pete O’Heeron, 281-461-6211
CEO
info@spinalcyte.com
or
Media Contact:
Pierpont Communications
Brittney Garneau, 713-627-2223
bgarneau@piercom.com

Ortho Sales Partners Adds Supply Chain and Logistics Executive to its Leadership Team

Posted On January 27, 2017 By OrthoSpineNews In Recon, Spine /

SCOTTSDALE, ARIZONA (PRWEB) JANUARY 27, 2017

Ortho Sales Partners, a professional consulting firm focused on assisting orthopedic and spine implant manufacturers in the commercialization of their products, announces the addition of Tony Passalacqua to their executive team, effective January 25, 2017. Mr. Passalacqua brings extensive experience to Ortho Sales Partners and will focus primarily on working with clients to optimize their sales operations by improving inventory management and utilization of costly instrument sets.

Mr. Passalacqua brings with him more than 27 years of supply chain and operational experience most recently serving as Vice President of Operations for an orthopedic distributorship that saw growth from approximately $20M to over $120M during his 10-year tenure. His primary responsibility was to create a scalable infrastructure, seamlessly on-board new product lines and categories, manage surgery schedules and recruit personnel to support an organization that was routinely participating in as many as 50 surgeries per day.

With a career that began in the United States Navy, Mr. Passalacqua earned his Bachelor of Science in Management from Arizona State University. He joined FedEx Ground where he led one of the largest and most profitable operations in the FedEx network. After 11 years at FedEx, Mr. Passalacqua joined Stryker Orthopaedics to transform the way they managed inventory in the field. He was responsible for facilities throughout the southwest including: California, Arizona, Nevada, Utah, Colorado and New Mexico.

“We are thrilled to have someone with Tony’s knowledge and experience join Ortho Sales Partners,” said Josh Sandberg. Co-Founder & General Manager. “Our mission is to help companies solve complex problems by leveraging our partners’ vast experiences and mitigate the risks associated with early market entry and commercialization. Tony will provide immense value to our clients and brings a skillset that few have in our industry.”

Regarding his new role, Mr. Passalacqua said: “It’s an honor to join an organization whose purpose and mission is to help people and companies grow their business. The unique challenges of the orthopedic industry and the ever changing landscape is an exciting problem to solve.”
_________

About Ortho Sales Partners – Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations such as:

A surgeon with a product idea and limited financial wherewithal to properly execute a sales plan.
OUS companies looking to establish or enhance their presence in the United States.
Companies with recent FDA approval in need of a strategic sales plan validated against current market conditions.
Established companies looking for marketing horsepower to properly launch a new product.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis rather than surgery volumes from over 4 years ago.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US.
http://www.orthosalespartners.com

VTI ADDS PATENT FOR ITS MODULAR MOTION PRESERVATION SPINAL IMPLANT

Posted On January 27, 2017 By OrthoSpineNews In Regulatory, Spine /

Minneapolis, MN – VTI, a MIS medical device company focused on lumber spine solutions, announced today that it has been granted a new patent from the U.S. Patent and Trademark Office. This patent relates to the company’s unique modular, in vivo assembly technology and its motion preservation, InterCushion® pipeline product. VTI now has over 25 patents and patent pending assets in its global intellectual property portfolio.

“The grant of this patent expands and lengthens VTI’s protection of our unique in vivo expansion technology for minimally invasive lumbar spine solutions. VTI is a world leader in lumbar spine focused motion preservation/disc nucleus replacement technology. This patent exemplifies our continued commitment to protect and broaden our intellectual property portfolio in this space. We are encouraged by the clinical results we are seeing from clinical trials using VTI’s modular technology in our InterCushion® product line,” commented Matthew R Kyle, President and CEO of VTI.

VTI’s InterCushion® lumbar spine motion preservation product has been successful in reducing pain, preserving disc, and halting modic changes in clinical trials in Canada. Currently, several patients are at or near 5 years’ post implantation with continued clinically successful outcomes.

Dr. Philip de Muelenaere stated “The potential value of an intervertebral nucleus replacement is linked to decreased future deterioration of the spinal motion segment. By maintaining disc height, the motion is maintained, stability is regained and long term collapse prevented. This protects the patency of the foramina, and decreases facet arthrosis which, apart from being a pain generator, will compromise the exiting nerve root.

The 5 year follow up MRI study proves that the prosthesis had maintained its position, maintained the disc height and kept the patients pain free.”

ABOUT VERTEBRAL TECHNOLOGIES, INC.

Vertebral Technologies, Inc. (VTI) is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells InterFuse® modular interbody fusion devices worldwide.

For more information visit, http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or +1.952-979-1811

Minimally invasive surgery “markedly reduces” postoperative infection risk

Posted On January 26, 2017 By OrthoSpineNews In Spine /

26th January 2017

Minimally invasive surgery is generally considered to reduce blood loss and preserve surrounding tissue, among other benefits. There is a dearth in the literature, however, on the association between minimally invasive techniques and surgical site infections.

Research published in the Asian Spine Journal has found very low rates of postoperative infection following minimally invasive spinal surgery in comparison to open surgery.

“One of the worst complications of any orthopaedic or spinal operation is surgical site infection,which can have devastating consequences,” lead author Arvind Kulkarni told Spinal News International. “Hypothetically, it appears that the incidence of surgical site infection should be minimal in minimally invasive surgery compared to open surgery—the reasons being lesser soft tissue dissection, lesser destruction of tissues, lesser exposure of surface area to pathogens etc.”

Records from 1,043 patients (52% male, 48% female; 52.2 years average age) undergoing tubular discectomies, decompressions and transforaminal interbody fusions at the Bombay Hospital and Medical Research Centre in Mumbai, India, from January 2007 to January 2015 were used to find the frequency of surgical site infection over the 12 months following each procedure.

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DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screw Systems

Posted On January 26, 2017 By OrthoSpineNews In Regulatory, Spine /

RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER^® and EXPEDIUM^®Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.

Metastatic spine disease accounts for 10 percent to 30 percent of new cancer diagnoses annually.¹ Surgical fixation with pedicle screws may be used as palliative care to stabilize the spine, help reduce pain and help keep the patient mobile.¹The VIPER and EXPEDIUM Fenestrated Screws are designed with a hollow shaft, or cannulation. This design along with holes called fenestrations above the screw tip enable controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement into the vertebra to provide immediate screw fixation.

“Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely,” said William C. Horton, M.D., Vice President of Research & Development, DePuy Synthes Spine. “We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease.”

The VIPER Fenestrated Screws are compatible with the VIPER and EXPEDIUM 5.5 Spine Systems and the EXPEDIUM Fenestrated Screws are compatible with the EXPEDIUM VERSE Spinal System. Both fenestrated screw systems are anticipated to be available in the United States in mid-2017.

Indications for Use

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER^® and EXPEDIUM^® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER^® and EXPEDIUM^® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates. Medos International, SARL is the legal manufacturer of the VIPER and EXPEDIUM Fenestrated Screw Systems.

DSUS/SPN/0117/1510 01/17

¹ Dunning, E.C, et al. Complications in the management of metastatic spinal disease. World J Orthop. 2012 Aug 18; 3(8): 114–121.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/depuy-synthes-receives-fda-clearance-for-cement-augmented-pedicle-screw-systems-300397372.html