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Current Issues in Spine

February 2-4, 2017

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August 18, 2017 OrthoSpineNews

By  | August 14, 2017

CMS announced on August 5 that they are considering whether to provide coverage for hip and knee replacement surgeries at outpatient surgery centers.

This kind of coverage could further incentivize patients to choose ambulatory surgery centers (ASCs) over traditional hospitals for outpatient procedures, which worries some hospital leaders. Not only could hospitals stand to lose revenue for joint replacement surgeries, a substantial portion of their income, but many doctors do not yet feel comfortable performing some of these operations in outpatient settings.

Just last year, the Advisory Panel on Hospital Outpatient Payment unanimously agreed that CMS should remove total knee replacement from the inpatient only list. However, not all patients are good candidates for outpatient total joint replacement surgeries, and surgeons should take into consideration a patient’s age, BMI, and overall health before opting for outpatient surgery.

It is estimated that demand for joint replacement surgeries will grow 77 percent over the next 10 years, but only 3 percent of these are predicted to be inpatient procedures. Currently only about half of joint replacement patients spend 1-2 days in the hospital while recovering, leading experts to believe that outpatient joint replacements are a respectable option for outpatient surgery centers.

 

READ THE REST HERE


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August 18, 2017 OrthoSpineNews

August 17, 2017/Kirrily Schwarznews.com.au

SOME surgeons are charging thousands more than others for routine surgeries, leaving hapless patients to foot the extra costs out-of-pocket.

A new report by the Royal Australasian College of Surgeons and Medibank says patients are being forced to pay as much as $5500 extra for knee and hip surgeries due to huge variations in surgical fees around the country.

Analysts used data from Medibank customers who claimed more than $5 as out-of-pocket expenses following surgery.

It’s pretty dry, but there are two significant takeaway points.

First: always shop around for a surgeon.

“There is a lot more to selecting a doctor than taking the first person that is recommended to you,” Dr Linda Swan, chief medical officer of Medibank, told Fairfax’s Kate Aubusson.

“[Cost] should be part of the referral process. They should be asking questions like ‘What is the expertise of this doctor?’, ‘How many procedures have they done?’, ‘What costs will I incur?’, ‘What hospitals will this doctor be able to walk right into?”

Second: consider flying to South Australia, where patients are asked to cough up much smaller amounts far less often than in other states.

KNEE REPLACEMENTS

The report surveyed 543 surgeons who performed at least five knee replacements, and found the cost of identical surgeries could range between $17,797 and $30,285.

Almost four out of every 10 patients were asked to cough up an average of $1885 — although that ranged as high as $5137.

Interestingly, while 59 per cent of patients were asked to shell out extra in New South Wales, only one per cent had to pay out-of-pocket in South Australia.

 

READ THE REST HERE

 


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August 18, 2017 OrthoSpineNews

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces that has successfully launched its High Offset (135º) Collared Origin HA Coated THA Stem.

Paxeon Reconstruction now offers the following options in it’s Origin HA THA Stem – 135º Standard Collared and Collarless, 135º High Offset Collared and Collarless, 125º Coxa Vara Collared – giving Paxeon Reconstruction 5 options (3 Collared, 2 Collarless) on its Origin Hip System.

“The goal in hip replacement is to restore the prediseased biomechanics of the hip.  Paxeon has released a lateralized collared stem which gives the surgeon an option to restore the native offset without lateralizing the center of rotation of the hip.  Paxeon has been very receptive in meeting the surgeons needs as demonstrated by bringing the lateralized collared stem to market” said Dr. Brian Rosenberg.

Kyle Sineath, President of Paxeon Reconstruction said: “The addition of a 135º Collared High Offset to our already proven hip implants is exciting for Paxeon. We strive to provide a complete portfolio for our successful Value Solutions Program to extend savings throughout the total joint continuum of care.”

“I am very pleased that Paxeon Reconstruction has addressed a specific need in total hip arthroplasty by producing the first truly collared lateral offset stem with impaction broaching technique using their Origin hip stem.  This new stem allows flexibility in hip arthroplasty that was previous unavailable in any stem using impaction broaching technique. It allows surgeons to adjust offset without changing neck angles or leg length so that we can better match the patient’s normal anatomy. This is just another example of Paxeon Reconstruction responding to surgeon needs in leading the way in total joint reconstruction innovation” said Dr. Kevin Pugh.

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

 


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August 18, 2017 OrthoSpineNews

NEW YORKAug. 16, 2017 /PRNewswire-USNewswire/ — The New York Cosmos announced today that Hospital for Special Surgery (HSS) will be the team’s official hospital. The new multi-year partnership provides the Cosmos access to one of the world’s leading centers for orthopedics and sports medicine. With this partnership, the Cosmos have officially named HSS physician Danyal H. Nawabi, M.D., as the Medical Director/Head Orthopedic surgeon for the team.

“Hospital for Special Surgery is a world leader in orthopedic care and the New York Cosmos are proud to enter into a partnership with them,” said Cosmos Chief Operating Officer, Erik Stover. “With Dr. Nawabi serving as the team’s Medical Director, we are ensuring that our players will receive nothing but the best medical coverage to help maintain a healthy team and provide a quick return to the field when injuries occur.”

“I’ve had the great experience of being involved with the English Premier League and Major League Soccer, and have always had an affinity for the game of soccer and a passion for caring for high performance athletes,” said Dr. Nawabi. “Now as a sports medicine surgeon at HSS it’s my privilege to oversee player care for the New York Cosmos and work with athletic trainers and coaches to keep the team safe and performing optimally on the field.”

Dr. Nawabi is an attending orthopedic surgeon on the Sports Medicine Service at HSS, specializing in knee, shoulder, and hip surgery, performing both arthroscopic and joint replacement surgeries. He completed his medical training at Oxford University in England and residency in orthopedic surgery on the prestigious Percivall Pott Rotation in London. Dr. Nawabi completed his fellowship in sports medicine at HSS and received additional training in sports knee and shoulder surgery while treating elite soccer athletes from the English Premier League and the MLS, including stints with Chelsea FC, West Ham FC, and the New York Red Bulls.

Dr. Nawabi will be joined by fellow HSS colleagues Brett Toresdahl, M.D., primary care sports medicine physician, and Mark Drakos, M.D., foot and ankle surgeon, who will serve as team physicians for the Cosmos. Together, they will provide orthopedic consultation services and oversee the rehabilitation of sports injuries and conditions at the Cosmos’ training facility, as well as at their home field, MCU Park, in Brooklyn.

HSS has been ranked the No. 1 hospital in the country for orthopedics for the eighth consecutive year by U.S. News & World Report. Doctors and therapists from HSS have the distinction of being the team physicians and athletic trainers for some of the most recognized professional sports teams and organizations including the Brooklyn Nets, the New York Knicks, the New York Giants, the New York Mets, the New York Rangers, the New York Red Bulls, UFC, USA Basketball and the FIFA Medical Centre of Excellence among many others.

About The New York Cosmos
The New York Cosmos are the reigning champions of the NASL and the most recognized American soccer brand in the world. Since beginning play at Yankee Stadium in 1971, the iconic club has won a record total of 8 professional soccer championships and brought some of the biggest stars in international soccer to the USA including Pelé, Franz BeckenbauerGiorgio ChinagliaCarlos Alberto, and more recently, Raúl and Marcos Senna.  With the move to MCU Park in Brooklyn’s historic Coney Island district for the 2017 season, the Cosmos are now based within New York City for the first time in 41 years. For more information on the New York Cosmos, please visit nycosmos.com, join us on Facebook and follow us on Twitter and Instagram (@NYCosmos).

About Hospital for Special Surgery
Hospital for Special Surgery (HSS) is the world’s leading academic medical center focused on musculoskeletal health. HSS is nationally ranked No. 1 in orthopedics and No. 3 in rheumatology by U.S. News & World Report (2017-2017), and is the first hospital in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. HSS has one of the lowest infection rates in the country. HSS is an affiliate of Weill Cornell Medical College and as such all Hospital for Special Surgery medical staff are faculty of Weill Cornell. The hospital’s research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. HSS has locations in New YorkNew Jersey and Connecticut.
www.hss.edu

 

SOURCE Hospital for Special Surgery


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August 17, 2017 OrthoSpineNews

August 16, 2017 – AAOS

Washington, DC–Yesterday, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule that addresses significant concerns raised by the American Association of Orthopaedic Surgeons (AAOS) related to mandatory bundled payment programs. First, the proposed rule would reduce the number of mandatory geographic areas participating in the Center for Medicare and Medicaid Innovation’s Comprehensive Care for Joint Replacement (CJR) model from 67 to 34. In addition, the proposed rule would allow CJR participants in the 33 remaining areas to participate on a voluntary basis. CMS also proposes to make participation in the CJR model voluntary for ALL low volume and rural hospitals in all of the CJR geographic areas. Finally, CMS is proposing to cancel the Surgical Hip and Femur Fracture Treatment (SHFFT) payment model and others that were scheduled to begin on January 1, 2018.

AAOS commends CMS for this important proposal and, after further analyzing all details in the rule, AAOS will be submitting comments by the October 16 due date.

 

READ THE REST HERE

 


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August 17, 2017 OrthoSpineNews

ATLANTA, GA–(Marketwired – Aug 17, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), the developer of the DenerveX™ System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today reported it has named Charlie Farrahar as its Chief Financial Officer.

Charlie Farrahar is a Certified Public Accountant with over 30 years of managerial finance, administration, human resource and risk management experience in the public, private and non-profit sectors. Mr. Farrahar was the first Chief Financial officer of the Company from its inception through IPO. He remained with the Company as its Secretary only from January 2015 until August 2017, when he agreed to resume the CFO role.

Mr. Farrahar currently serves as Chief Financial Officer for several small private biotech companies in the research and development stage. In 2003 he joined a private governmental assistance startup as it’s CFO and Director of Human Resources, helping with the sale of that company to a private entity in 2011 after it had grown to a multi-state operation with over 400 employees. In the late 1990’s he was CFO of Credit Depot Corp. (Nasdaq).

At its August 16, 2017 quarterly Board meeting, the Board asked Charlie Farrahar, Company Secretary, to become Chief Financial Officer, a role he held from the inception of the Company through its initial public offering. Jeffery Wright, the former CFO, agreed to become the Company’s first Controller.

Jarrett Gorlin, Medovex Chief Executive Officer, stated, “We’re excited by the enthusiastic reception we’ve seen thus far to the Denervex product and realize that we have to properly support sustained revenue growth. One area affected by this growth is the financial/accounting function. With the addition of overseas sales and all the administration that entails, we were no longer able to have just one full-time person in the finance area.”

Gorlin continued, “We asked Charlie Farrahar to become CFO so Jeff Wright could focus on assisting our sales and distribution efforts as we expand sales into multiple countries. They have complementary skill sets and work well together. Their combined experience should allow us to properly steward anticipated growth associated with the launch of a successful new product targeting a broad audience.”

The Company’s DenerveX System recently received CE Mark approval and clearance for commercialization in the European countries and offers a unique way to perform a Facet Joint Syndrome treatment.

Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.

The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.

The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

  • CONTACT INFORMATION
    Medovex Corp.
    Jason Assad
    470-505-9905
    Email Contact

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August 17, 2017 OrthoSpineNews

CONN HASTINGS, MedGadget / August 9th, 2017

Scientists at UT Southwestern Medical Center have developed a new technique using high-frequency alternating magnetic fields to heat artificial joints in the body and destroy bacterial films on their surfaces.

Bacterial infections on artificial joints used in knee and hip replacements are a common and serious complication. The bacteria tend to form slimy films on the metal surfaces of the joints called biofilms, and they are difficult to treat using antibiotics.

Dr. David Greenberg, of UT Southwestern Medical Center, describes the solution the researchers developed. “We were looking for better ways to target and treat biofilms,” he says. “Our idea was to put a coil around the joint and run a current through it to create alternating magnetic fields. Human tissue isn’t conductive but metal is, so only the implant would heat up.” The principle is the same as that in induction cooktops, which use magnetic fields to heat metal pots for cooking.

 

READ THE REST HERE


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August 17, 2017 OrthoSpineNews

AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that the Excelsius GPS™, a revolutionary robotic guidance and navigation system, has been 510(k) cleared by the U.S. Food and Drug Administration. This platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw placement applications in spine and orthopedic surgery. Excelsius GPS™ seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

“Excelsius GPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation.  “We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

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.

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 successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become 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 our 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: Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

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August 16, 2017 OrthoSpineNews

NEW DELHI, Aug 16 (Reuters) – India has capped prices of orthopaedic knee implants, in the country’s latest move to bring down prices of medical devices.

The introduction of price controls marks the latest step by Prime Minister Narendra Modi’s government to make drugs and medical devices more affordable. In February, it imposed a 75 percent price cut for certain heart stents – wire mesh tubes used to treat blocked arteries, which caused protests among manufacturers.

India’s drug pricing authority said on Wednesday that orthopaedic implants in India had unjustified, unreasonable and irrationally high trade margins, leading to exorbitant pricing.

Ananth Kumar, Minister of Chemicals and Fertilisers, told a news briefing the government had capped knee implant prices “in public interest.”

Kumar said the price of the widely used cobalt chromium knee implant, priced at up to 250,000 rupees ($3,895) at Indian hospitals, would now be capped at 54,720 rupees ($852).

 

READ THE REST HERE


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August 16, 2017 OrthoSpineNews

August 16, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration.

Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.1,2 The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

“Pedicle screws have been used for decades with very few changes to their design,” said Bradley Paddock, President of Stryker’s Spine division. “The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect.”

Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

References

1. Stryker Patent #6,074,391
2. Stryker Design History File DHF0000016688

Content ID TLSER-PR-1_14675

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com