Carevature Medical’s Dreal™ Decompression System is Safer for Patients, Says Recent Article

Posted On September 10, 2018 By OrthoSpineNews In Spine /

TEL AVIV, Israel, Sept. 5, 2018 /PRNewswire/ — According to a recent article in the International Journal of Spine Surgery, advanced decompression innovator Carevature’s Dreal™ device yields significantly better results in incidental dural tears, with 87% improvement compared to high-speed drills and Kerrison Rongeurs (0.4% vs. 2.91%; p<0.01); and 80% improvement compared to ultrasonic bone cutters (0.4% vs. 1.95%; p<0.01).

This data demonstrates the Dreal™’s marked advantages in reducing natural risk of neural element injury. The results are attributed to the device’s unique curved and shielded tip design, which requires only a very limited number of passes to remove the target pathology.^[1]

“This confirms what my colleagues and I have been experiencing in our surgical practice,” says Dr. Ely Ashkenazi, MD, neurosurgeon and senior spine surgeon at Tel Aviv’s Israel Spine Center, where he and his team have used the Dreal™ in over 200 cervical, thoracic, and lumbar spine procedures.

“I’ve been deeply impressed with the design and function of these devices,” adds Scott C. Kutz, MD, neurosurgeon at the Texas Back Institute (Plano, TX). “I don’t believe any other device on the market can provide these results. Furthermore, it increases the efficiency and safety with which I can perform multiple, dissimilar spinal procedures. In particular, these devices are extremely helpful in minimally invasive spine surgery – a market segment that’s expanding relative to standard spine surgery. I expect that use of the Dreal™ system will grow exponentially over the next few years, in step with the demand for minimally invasive spinal techniques.”

Says Charlie Harrison, President of Carevature Medical, Inc. (Marietta, GA): “We’ve all been waiting for the new line of bayoneted designs, which truly raises the bar for decompression systems. Feedback from surgeons has been superb, and we’re confident that this overwhelmingly positive response will be a major step towards the Dreal™’s rapid expansion in US markets and beyond.”

ABOUT CAREVATURE

Carevature Medical Ltd., a privately-held medical device company headquartered in Rehovot, Israel, is dedicated to developing advanced orthopedic surgery solutions. Carevature is currently marketing its flagship line of products for spinal indications, Dreal™: the first and only curved device powerful enough to efficiently cut bone, and small enough for use in all sections of the spine. Over 800 patients worldwide have been treated with the Dreal™, with outstanding safety and recovery results.

www.carevature.com

^[1]Suitability of Administrative Databases for Durotomy Incidence Assessment: Comparison to the Incidence Associated With Bone-Removal Devices, Calculated Using a Systemic Literature Review and Clinical Data. Robert Pflugmacher, Angelo Franzini, Shaked Horovitz, Richard Guyer, Ely Ashkenazi. International Journal of Spine Surgery Aug 2018, 12 (4) 498-509; DOI: 10.14444/5061

Media contact:

Robert W. Cook, VP Marketing & Sales

Carevature Medical, Inc.

M: +1-260-417-1643

E: bob@carevature.com

SOURCE Carevature Medical Ltd.

Top Joint Replacement Surgeon To Lead NYU Langone’s Adult Reconstructive Surgery Division

Posted On September 10, 2018 By OrthoSpineNews In Recon /

NEW YORK, Sept. 10, 2018 /PRNewswire/ — William Macaulay, MD, an internationally renowned expert in hip and knee treatments and surgery, has been appointed Chief of the Division of Adult Reconstructive Surgery in the Department of Orthopedic Surgery at NYU Langone Health. The new appointment is effective August 23, 2018.

Dr. Macaulay first joined NYU Langone in January 2017 as its medical director for International Patient Services. In that role he oversaw an expansion of the health system’s program matching international patients with top physicians in a wide variety of medical and surgical disciplines. He will maintain this position as he assumes his new role.

Macaulay also serves as professor of orthopedic surgery in the Division of Adult Reconstructive Surgery, performing his surgical procedures at NYU Langone Orthopedic Hospital in Manhattan. In addition, he consults with patients at several of NYU Langone’s state-of-the-art outpatient facilities, including the Preston Robert Tisch Center for Men’s Health in Manhattan and NYU Langone Orthopedics—Westchester.

“We are thrilled to have Dr. Macaulay’s vast orthopedic expertise and renowned leadership spearheading NYU Langone’s adult reconstructive surgery division,” says Joseph D. Zuckerman, MD, the Walter A. L. Thompson Professor of Orthopedic Surgery and chair of the Department of Orthopedic Surgery. “Dr. Macaulay enjoys international acclaim, and will apply his experience to continue to elevate our division, which is recognized for its extensive clinical, educational and academic activities.”

About Dr. Macaulay: A Leader in Hip and Knee Care

Dr. Macaulay specializes in orthopedic procedures including primary and revision total knee and total hip replacement, partial knee replacement, hip resurfacing, hip fracture repair and knee arthroscopy. For the most complex cases, he utilizes new technologies, including robotics and computer-assisted navigation, to ensure optimal outcomes.

Prior to joining NYU Langone, Dr. Macaulay served as chief of the Division of Hip and Knee Surgery and director of the Center for Hip and Knee Replacement at NewYork-Presbyterian (NYP) at Columbia. He also served as the director of Orthopedic Surgery at NYP/Lawrence Hospital in Westchester County, and had been a member of the faculty at Columbia University Medical Center for 17 years, acting as Advisory Dean at The College of Physicians and Surgeons for 7 years. He was also the founder and director of their hip and knee replacement fellowship program. Dr. Macaulay earned his medical degree from Columbia University College of Physicians and Surgeons, and completed his surgery internship and orthopedic surgery residency at University of Pittsburgh Medical Center. He also completed a postdoctoral arthroplasty fellowship at the Hospital for Special Surgery in New York.

An accomplished researcher and clinician, Dr. Macaulay has received more than a dozen awards and honors for his work in hip and knee orthopedic care. He was named one of the “25 Best U.S. Knee Surgeons” by Becker’s ASC Review. He is also a member of several prestigious medical societies, including The Hip Society, The Knee Society, and the American Association of Hip and Knee Surgeons, the latter of which presented him with the Lawrence D. Dorr Surgical Techniques and Technologies Award in 2007. For the last two decades, Dr. Macaulay’s research has focused on advances in hip and knee reconstructive surgery, such as surgical recovery enhancement and outcomes of hip and knee replacement surgery, including partial knee replacement and hip resurfacing. He has served as a site investigator, principal investigator, and steering committee member of several prominent randomized clinical trials.

“It’s a true honor to be selected to oversee one of the largest and most renowned adult reconstructive surgery divisions in the United States, whose faculty is lauded for pushing the envelope in cutting-edge treatments and new research to provide top orthopedic care,” says Macaulay.

Why Choose NYU Langone for Joint Replacements

The Adult Reconstructive Surgery Division at NYU Langone is one of the largest in the country, with 36 surgeons who performed more than 4,500 procedures last year. Our total joint replacement surgeons are experienced in minimally invasive joint replacement techniques and work with the latest technology and equipment in specialized orthopedic operating rooms. They use their expertise in planning, as well as during, all surgical procedure to address their patient’s joint problems and ensure the best possible outcomes.

NYU Langone ranks No. 8 in the nation in Orthopedics, according to U.S. News & World Report‘s “Best Hospitals 2018-2019 Honor Roll.” It also ranks No. 2 in New York State and number two in the New York metro area. Equally noteworthy, NYU Langone is the only hospital in New York to receive top 10 rankings for all three musculoskeletal specialty disciplines: orthopedics, rheumatology, and rehabilitation.

Patients who choose to travel from outside of the United States can find expert assistance at NYU Langone, where care coordinators match patients with the appropriate doctors and treatment options. The team also helps arrange travel and local accommodations for accompanying family members, and ensures patients have medical interpreters during all phases of care, including via telephone, video, or face-to-face consultations.

International patients seeking care can contact NYU Langone’s International Patient Services Program at (212) 263-3588, or by email at internationalservices@nyulangone.org. Please include your name, country of origin, preferred contact method, and preferred language. Documents can also be faxed to 646-501-5296.

Media Inquiries:

Ryan Jaslow

Phone: 212-404-3511

ryan.jaslow@nyulangone.org

SOURCE NYU Langone Health

Photo: (PRNewsfoto/NYU Langone Health)

Amedica Announces Filing of Key Patent Application Relating to the Anti-Viral Effect of its Silicon Nitride

Posted On September 10, 2018 By OrthoSpineNews In Regulatory, Top Stories /

SALT LAKE CITY, Sept. 10, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride for biomedical applications, today announced the filing of a U.S. patent application for breakthrough research findings that have identified a new property of its proprietary silicon nitride.

Amedica investigators led by Dr. Giuseppe Pezzotti, a professor at the Kyoto Institute of Technology (Japan) and consultant to Amedica Corporation, have developed micromeritic silicon nitride powders as well as bulk surfaces that are effective against several strains of commonly prevalent viruses – including Influenza A virus (H1N1), the virus responsible for the 2009 flu pandemic. The research has also identified the surface chemical properties of silicon nitride that contribute to the observed virucidal effect.

The mechanism, known as alkaline transesterification, is known to cause genomic cleavage in active viruses leading to their inactivation and lysis. The investigation employed a commonly accepted assay of measuring mammalian cell viability in the presence of high concentrations of virus particles. In the case of Influenza A virus, a 5-minute exposure to Amedica’s silicon nitride either at room temperature or at 4^oC was enough to result in complete virus lysis and inactivation such that 100% of the exposed cells survived. In an identical parallel test conducted without silicon nitride, the virus remained intact and was able to infect and destroy exposed cells. Silicon nitride proved to be an effective disinfectant of the virus thus providing a protective effect to cells exposed to the virus.

“These unexpected results are of course entirely welcome, and the remarkable discovery opens new frontiers in our evolving understanding of silicon nitride as a biomaterial and in practical applications of it,” said Dr. B. Sonny Bal, Chairman and CEO of Amedica Corporation. “The discovery is particularly timely given our recent divestment of the retail spine business to CTL Medical and our transition to an OEM manufacturer and biomaterials company.”

“From the standpoint of spine surgery, the antiviral properties of silicon nitride implants probably have little consequence since viral infections of implanted biomaterials are not a practical problem. On the other hand, systemic viral infections and their spread through contaminated surfaces are a global concern. Drug treatments of established Influenza A infections, such as Tamiflu, are effective only in controlling symptoms by reducing viral load and the virus can still mutate to newly resistant, dangerous strains. The control of viral propagation by surface sanitization is therefore of worldwide interest; witness the hand sanitizers and other protections used commonly during the flu season. Surface sanitization destroys the virus itself, and commonly-used methods rely on ammonia, alcohol, silicon nanoparticles, and certain pH conditions to inactivate virus particles.”

“The latest findings show the above-surface conditions for viral disinfection are already manifest on Amedica’s silicon nitride whether the material is studied in bulk form or as a micron-layer coating on other surfaces. This property is a powerful advantage toward safe and reliable methods for viral inactivation and elimination. This fortuitous, intrinsic anti-viral effect of Amedica’s silicon nitride has broad applications in health care, from medical therapies to various medical devices and equipment such as examination tables, clothing, filters, masks, gloves, catheters, endoscopic instruments, and well beyond.”

“Previous data, supported by clinical studies, have established that Amedica’s silicon nitride enhances osteogenesis while resisting bacterial adhesion; both highly desirable properties in spinal fusion implants. Now, the material appears to be equally effective against the world’s most common pathogens, i.e., viruses that are responsible for a number of diseases and their global spread. Going forward, we will seek commercial applications and partnerships that can leverage the unique antiviral behavior of silicon nitride, a property that, to our knowledge, is not present in any other biomaterial known in the world today.”

Further to today’s announcement, Amedica will host a conference call on September 13, 2018 to discuss the agreement with CTL Medical and to provide a business update. Details related to this call will be provided at a later date.

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties, including without limitation the risks associated with generating data to support the patent application for the technology and of obtaining a patent that provides commercially significant protection for this technology; the risk that the technology may infringe the proprietary rights of third parties. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

Contacts: Amedica IR 801-839-3502 IR@amedica.com

Mandatory joint pay model slashes spending in just eight months

Posted On September 7, 2018 By OrthoSpineNews In Regulatory /

By Virgil Dickson | September 6, 2018

A mandatory pay model aimed at reducing Medicare spending on joint replacement surgeries was able to save money in its first year. The CMS in recent years has scaled back and canceled mandatory models.

Under the Comprehensive Care for Joint Replacement program, average total payments decreased by 3.9% or $1,127 compared to hospitals not participating in the model, according to federal data released Wednesday. At the same time, researchers observed no statistically significant changes in the quality of care as measured by readmission rates, emergency department visits, and deaths.

The program gives hospitals a fixed payment for all services related to joint replacement surgeries from admission to 90 days after the procedure, with no additional payments for complications, readmissions or post-acute services.

“Possibly the most notable outcome during the first CJR model performance year was that statistically significant changes in utilization and payments occurred so quickly,” the report said.

The study analyzed results from 731 CJR participant hospitals and 841 hospitals not in the experiment, which lasted from April 1 to Dec. 31, 2016.

Last year, the CMS scaled back the CJR program citing the burden of the program and the belief that models should be largely voluntary. The CJR model is now only mandatory in 34 geographic areas compared to 67 geographic areas when it first launched.

The agency estimates that 465 hospitals are participating in the effort. That figure is down from 800 acute-care hospitals that were expected to participate in the program.

After interviewing hospital staff, researchers said there may not have been a change in the practice of medicine at these facilities had the experiment not been mandatory.

“These findings suggest that a mandatory model may impel action across a broad range of hospitals that may not otherwise have acted to reduce episode payments,” the report said.

Proponents of value-based care hope the results will encourage the CMS to reconsider the use of mandatory models. Many of the hospitals in CJR are ones that chose to skip other pay models such as the Bundled Payments for Care Improvement Initiative, according to Andrew Ryan, an associate professor in the department of health management and policy at the University of Michigan’s School of Public Health.

READ THE REST HERE

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Hospitals Prepare To Launch Their Own Drug Company To Fight High Prices And Shortages

Posted On September 7, 2018 By OrthoSpineNews In Regulatory /

September 6, 2018 / ALISON KODJAK

Sometimes IV bags are hard for hospitals to come by. Other times it’s injectable folic acid to treat anemias. Right now, the tissue-numbing agent lidocaine is in short supply.

Shortages of commonplace generic drugs have plagued hospitals in recent years. And with short supplies and fewer suppliers for key drugs, there have been price increases.

Hospital purchasing agents keep searching for new sources for the medications that patients need, while clinicians scramble to find alternatives.

“Every day at Intermountain we manage more than 100 drug shortages, and most of them are generics,” said Dr. Marc Harrison, president and CEO of Intermountain Healthcare, a system of 22 hospitals based in Salt Lake City. “The impact on patient care, in terms of trying to find alternatives and scurrying around and trying to find necessary drugs, is incredibly time-consuming and disconcerting.”

Now Intermountain, along with several other major hospital systems and philanthropies, is taking the problem in hand. They are launching a nonprofit, generic drug company to help fight rising costs and chronic shortages.

The company, called Civica Rx, will be independent. But the board will include so-called governing members that include Intermountain, the Mayo Clinic, and for-profit HCA Healthcare, among others. The companies are unveiling the new venture’s name, structure and leadership on Thursday. The intention to start it was announced in January.

The new company plans to market 14 common generic drugs that have been in short supply and whose prices have risen in recent years. Harrison declined to name the drugs.

“As we decided on the drugs we were really practical,” Harrison said in an interview. “We looked for drugs that were now in short supply. We looked for drugs that were on the lists of essential medications, and we looked for drugs that have had huge spikes in their prices.”

Drug shortages have become so widespread that Food and Drug Administration Commissioner Scott Gottlieb in July created a task force to come up with solutions. And last year the Justice Department, along with 45 states, accused a group of generic drug makers of price fixing.

READ THE REST HERE

Photo: Courtesy of Intermountain Healthcare

LimaCorporate Announces Milestone-based Acquisition of TechMah Medical LLC to Expand Digital Footprint in Orthopaedics

Posted On September 7, 2018 By OrthoSpineNews In Recon /

SAN DANIELE DEL FRIULI, Italy, September 6, 2018 /PRNewswire/ —

LimaCorporate, a pioneer and leader in 3D printing of Orthopaedic implants, announces the milestone-based acquisition of TechMah Medical LLC (“TechMah Medical”), a medical device software company located in Knoxville, Tennessee, to complement its hardware portfolio with digital applications.

TechMah Medical was founded in 2014 and focuses on digital technologies dedicated to orthopaedic surgery that impacts the quality of care and fits into today’s cost constraints. Dr. Mohamed Mahfouz, Professor of Biomedical Engineering at the University of Tennessee, is the founder of TechMah Medical. Dr. Mahfouz has over 20 years’ experience within Orthopaedics and holds over 300 publications on implant design, imaging, kinematics, sensors, anthropology and forensics. Dr. Mahfouz will continue to be involved with TechMah Medical and will become a long-term partner to LimaCorporate.

The team at TechMah Medical consists of world-class researchers and engineers in bio-wireless electronics, biomechanics, imaging, as well as software and will focus on the release of software and smart instruments which will be used in combination with LimaCorporate implants.

This investment in software know-how, together with the internal 3D printing expertise, brings LimaCorporate to the forefront of digital transformation of the Orthopaedics industry through highly-innovative digital solutions that will change the approach to surgery and standard instrumentation.

Under the terms of the agreement, LimaCorporate will provide funding to TechMah Medical and complete the acquisition as key product development goals are achieved, becoming the sole shareholder of TechMah Medical over time, while Dr. Mahfouz and his team will remain involved with the business. Financial terms have not been disclosed.

“LimaCorporate is the most innovative and agile company in Orthopaedics today and the ideal partner for us to develop our technology and advance the digitization of the industry,” said Dr. Mahfouz from TechMah Medical.

Luigi Ferrari, CEO of LimaCorporate, commented, “We are excited about this transaction and the partnership with Dr. Mahfouz. Combined with our proven implant technology and 3D printing capabilities, this acquisition will allow LimaCorporate to develop a strong foothold in all digital applications surrounding Total Joint Replacement by offering surgeons a new intra-operative experience and by providing their patients flexible personalized care.”

About LimaCorporate

LimaCorporate is a global medical device company providing reconstructive Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

About TechMah Medical

TechMah Medical LLC is a technology company focused on delivering orthopedic solutions. We build innovative applications designed to improve patient and clinician experience throughout the joint replacement process. Based in Knoxville, Tennessee, our team of scientists and engineers are driven to improve quality and efficiency through customization.

For additional information on the Company, please visit: limacorporate.com

Limacorporate S.p.A.

Via Nazionale, 52

33038 Villanova di San Daniele

Udine – Italy

T: +39-0432-945511

E: info@limacorporate.com

SOURCE Limacorporate S.p.A

St. Mary’s Medical Center Selected to Study Use of TOPS™ System

Posted On September 6, 2018 By OrthoSpineNews In Spine /

SAN FRANCISCO, Sept. 5, 2018 /PRNewswire/ — The Spine Center at Dignity Health St. Mary’s Medical Center, has been selected to participate in a FDA/IDE pivotal study, sponsored by Premia Spine, Ltd., studying the use of the TOPS™ System. St. Mary’s Medical Center is one of 30 spine centers throughout the U.S. taking part in the study to evaluate the efficacy and safety of the TOPS™ System compared to traditional lumbar fusion.

The TOPS™ System is a mechanical device designed to restore motion of the spine in all directions. Instead of permanently locking the two vertebrae with a fusion, the device allows the two vertebrae to continue moving. If approved, TOPS™ would potentially be the first posterior arthroplasty device for the treatment of degenerative Grade I spondylolisthesis and spinal stenosis.

“We are very excited to be selected as investigators in the TOPS™ System study because it offers a unique opportunity for patients who meet the study’s criteria to potentially receive a motion preserving device for the surgical treatment of degenerative spondylolisthesis and spinal stenosis,” said Dr. James Zucherman, orthopedic surgeon and medical director of the St. Mary’s Spine Center.

Patients participating in the study will either undergo surgery with the TOPS™ System or lumbar spinal fusion. Patients are randomly placed into one group or the other with a 67 percent likelihood of undergoing surgery with the Premia device.

“There are countless people suffering from debilitating back pain caused by a slipped disc or narrowing of the spine who must either manage the pain through physical therapy and injections or undergo surgery,” added Dr. Zucherman. “We believe that this study will provide us the scientific data needed to support the continued use of technologies that aim to correct underlying spinal conditions while helping to restore range of motion.”

Study participants must be experiencing:

radiating leg pain,
greater leg or buttock pain than back pain,
severe pain after walking as little as 100 yards or 2 minutes,
and/or pain that reduces when sitting, bending forward, or leaning over a shopping cart.

These symptoms could be signs of degenerative spondylolisthesis, spinal stenosis and additional spinal conditions. Patients can learn more about the TOPS™ System study by calling (415-750-5836) or visiting http://www.ClinicalTrials.gov, search NCT03012776.

About Dignity Health St. Mary’s Medical Center

Dignity Health St. Mary’s Medical Center is an accredited, not-for-profit community hospital that has been caring for the people of San Francisco since 1857. Located across from Golden Gate Park, it is the longest continually running hospital in San Francisco. For three consecutive years, from 2014 to 2016, St. Mary’s received the Distinguished Hospital Award for Clinical Excellence from Healthgrades. St. Mary’s also was recognized as one of the Top 100 Orthopedic Programs nationally by Becker’s Hospital Review and is a Certified Stroke Center by the Joint Commission. St. Mary’s state-of-the-art Cancer Center offers the full-range of oncology, radiation, and imaging services. Offering the most comprehensive breast imaging services in San Francisco, St. Mary’s has been designated as a Center of Excellence by the American College of Radiology, a recognition that represents the national gold standard. For more information, call 855.970.2938.

Join Our Community

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SOURCE Dignity Health St. Mary’s Medical Center

Positive Commercial Payor Policy Covering coflex® For The Surgical Treatment Of Lumbar Spinal Stenosis

Posted On September 6, 2018 By OrthoSpineNews In Spine /

NEW YORK, Sept. 6, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, announces issuance of a BlueCross BlueShield of South Carolina Medical Policy, entitled “Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)” dated August 2018.

Lumbar spinal stenosis (“LSS”), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS includes a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex^® device is a non-fusion, motion-preserving stabilization implant, that is FDA PMA approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

To learn more about coflex^® Interlaminar Stabilization^®, please visit www.coflexsolution.com.

Marc Viscogliosi, Chairman & CEO – “With more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, spine medical society guidelines, and now with additional commercial insurance coverage, it is wonderful to be able to expand patient access to the coflex^® technology.”

About Paradigm Spine, LLC

Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 60 countries worldwide. coflex^® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

(PRNewsfoto/Paradigm Spine, LLC)

The coverage policy may be found here: http://www.cam-policies.com/internet/cmpd/cmp/mdclplcy.nsf/DispContent/A50CA6ABF1D50CAF8525811E0062FC38?opendocument

Reston Hospital Center Launches Training Program for Robotic Guided Spine Surgery

Posted On September 6, 2018 By OrthoSpineNews In Robotics, Spine /

Reston, Virginia, Sept. 06, 2018 (GLOBE NEWSWIRE) — The Virginia Institute of Robotic Surgery at Reston Hospital Center has announced the launch of its Visiting Clinician Program (VCP) for robotic assisted spine surgery using the Mazor X Robotic system, a partnered program with Medtronic. The VCP at Reston Hospital Center will be led by Dr. Christopher Good, spinal surgeon at the Virginia Spine Institute (VSI). As the Director of Scoliosis & Spinal Deformity Surgery at VSI, Dr. Good is at the forefront of spine surgery and has performed the Mid-Atlantic’s first and most advanced procedures using robotic assisted technology at Reston Hospital Center.

“Our team has been leading the way in implementing the latest in surgical innovations for years,” said John Deardorff, President and CEO of HCA’s Northern Virginia Market and Reston Hospital Center. “Consistently providing excellent patient care and superior results, Reston Hospital Center has become recognized as a destination that surgeons from around the world come to train.”

The VCP at Reston Hospital Center is designed to enable spine surgeons from around the world to see the technology while learning best practices for implementation in another facility or surgical program.

A visit to the program includes a case observation, as well as an opportunity to complete a training curriculum and to spend time with Dr. Good, learning the technology and how its best applied in complex cases. Visiting surgeons will also be exposed to the daily operations of running a comprehensive robotic surgery program from the administrative perspective, while having the opportunity to speak with leadership from the surgical services area.

“Our research is showing that this robotic technology can decrease radiation to patients in the operating room, as well as improve the safety for patients having spine surgery,” said Dr. Christopher Good. “The launch of this Visiting Clinician Program at Reston Hospital Center is just one more step toward ensuring that our patients have the safest and most advanced treatment available to them; and, now, I have the pleasure of giving the same opportunity to surgeons around the world.”

The robotic assisted technology is used for pre-planning minimally invasive as well as complex spinal reconstruction procedures. It allows spine surgeons to precisely plan out the desired surgery and to carry out the procedure with a high degree of confidence and accuracy.

About Reston Hospital Center

Part of HCA Virginia Health System, Reston Hospital Center is a 187-bed, acute-care medical and surgical facility that has garnered high honors for attentive patient care and nursing excellence. Reston Hospital Center is home to the region’s newest Level II Trauma Center and the most comprehensive robotic surgery in the Mid-Atlantic. Statewide, HCA Virginia Health System operates 14 hospitals and more than 30 outpatient centers and is affiliated with 3,000 physicians. It is Virginia’s fourth‐largest private employer, provides $190.8 million in charity and uncompensated care, and pays $72.6 million in taxes annually. For more information about Reston Hospital Center visit www.restonhospital.com.

Erin Echelmeyer
Reston Hospital Center
703-689-9030
Erin.Echelmeyer@hcahealthcare.com

Baxter Announces U.S. FDA Clearance of New Bone Graft Substitute, Actifuse Flow

Posted On September 6, 2018 By OrthoSpineNews In Regulatory /

Deerfield, Ill. – September 6, 2018

Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (FDA) clearance of Actifuse Flow Bone Graft Substitute for use in a variety of orthopedic surgical procedures. As the newest addition to Baxter’s growing osteobiologics surgery portfolio, Actifuse Flow offers accelerated bone growth in a new, easy-to-use, prepackaged delivery syringe for precise placement into small bony voids or gaps in the skeletal system.

Actifuse Flow utilizes the proprietary silicate-substituted technology of Baxter’s Actifuse Bone Graft Substitute, which enhances silicon levels to accelerate bone formation[i]. Actifuse Flow comes ready to use with no mixing or preparation involved and maintains its flowable consistency throughout surgery. The bone graft substitute is delivered directly from a pre-loaded syringe with the ability to start and stop delivery, making it compatible with open and less invasive surgical techniques and well-suited for filling small bone defects and complex geometries. As the graft substitute resorbs, it is replaced by the patient’s own bone during the body’s healing process. Baxter expects Actifuse Flow to be used in a variety of orthopedic surgeries in the pelvis, extremities, and posterolateral spine.

“Baxter’s Actifuse Bone Graft Substitute has been demonstrated in preclinical models to show greater new normalized bone volumes over other available bone graft substitutes. As the graft resorbs into the body, it is replaced by natural bone during the healing process. Actifuse Flow offers that same reliability in an easy-to-use delivery device. I am pleased to count on the science behind Actifuse Flow to accelerate bone formation in my patients,” said Robert Norton, MD, an orthopedic spine surgeon serving patients in Boca Raton, Florida.

“As part of our growing product portfolio, Actifuse Flow builds on the extensive clinical experience of our Actifuse Bone Graft Substitute,” said Wil Boren, president of Baxter’s Advanced Surgery business. “We strive to pioneer products that provide surgeons innovative and dependable tools to help enhance healing, improve outcomes and reduce the total cost of care.”

Actifuse Flow is the latest addition to Baxter’s osteobiologics surgery portfolio, which also includes Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore. These products are based on a proprietary silicate-substituted technology designed to accelerate bone growth and come in varying configurations to accommodate different surgical needs. Baxter expects Actifuse Flow to be available to U.S. customers by year-end. It will be sold in three convenient sizes: 5 mL, 3 mL and 1.5 mL.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

Actifuse Flow Bone Graft Substitute Indication

Actifuse Flow is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bone structure. Actifuse Flow is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Important Risk Information for Actifuse Flow Bone Graft Substitute

Actifuse Flow is contraindicated where the device is intended as structural/load-bearing support in the skeleton system. Actifuse Flow bone graft substitute has not been cleared for vertebroplasty.

Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.

The effect of mixing Actifuse Flow with substances other than sterile saline/water, autologous blood or bone marrow aspirate is unknown.

Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.

This release includes forward-looking statements concerning Actifuse Flow, including potential benefits associated with its use [and anticipated launch dates]. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

Baxter, Actifuse Flow, Actifuse ABX, Actifuse Shape, Actifuse MIS and Altapore are registered trademarks of Baxter International Inc.

[i] Hing KA, et al. Comparative performance of three ceramic bone graft substitutes. Spine J. 2007; 7(4):475

Author: OrthoSpineNews