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Inspired Spine Presents Research at Society for Minimally Invasive Spine Surgery Annual Meeting

Posted On November 7, 2016 By OrthoSpineNews In Spine /

Las Vegas, Nevada (PRWEB) November 07, 2016

Inspired Spine recently presented its groundbreaking research at the Society for Minimally Invasive Spine Surgery in Las Vegas, Nevada. The study focused on the cost savings to hospitals with its innovative spinal implant – the Oblique Lateral Lumbar Interbody fusion (OLLIF).

The research was presented by renowned spine surgeon and main author Hamid Abbasi MD, who has performed hundreds of OLLIF procedures. The study compared 69 OLLIF procedures to 55 of the TLIF procedures, which is short for transforaminal lumbar interbody fusion.

The study showed significant differences between the procedures. Lumbar fusion procedures with the OLLIF implant entailed one tenth the blood loss as the TLIF procedure, much less time in the OR, and 40% reduced hospital length of stay. Incisions are smaller, pain is less, with the main outcome in the study being thousands of dollars saved per case to a hospital.

Between the reduced surgical time and hospital stay, average cost savings compared to TLIF ranged from 30 to 50% and over $10,000 per case. In addition, the reduced time per case with the OLLIF implants can lead to a greater throughput per operating room and patient bed for hospitals under constraints.

The conclusion of the study is that the OLLIF procedure makes it an appealing alternative to the traditional open fusions. Along with presenting at the SMISS conference, the paper has also been published in the peer-reviewed journal Cureus and is indexed in PubMed.

Christopher Murphy, President of Inspired Spine, said, “I’m excited every time an Inspired Spine study is given the opportunity to provide an oral presentation. Audience and industry reception has been fantastic, and it shows in our ever increasing number of physician partnerships.”

For more information on the OLLIF implant, visit http://inspiredspine.com and call Inspired Spine at (888) 378-2828.

For the original version on PRWeb visit: http://www.prweb.com/releases/ollif-medical-device/minimallyinvasivespine/prweb13812715.htm

Providence Medical Technology Announces the Launch of CAVUX™ Cervical Cage-L and DTRAX® Spinal System-L

Posted On November 7, 2016 By OrthoSpineNews In Spine /

WALNUT CREEK, Calif., Nov. 7, 2016 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical fusion technology, today announced the commercial launch of its new CAVUX Cervical Cage-L and DTRAX Spinal System-L.

The CAVUX Cervical Cage-L is an intervertebral cage made of solid titanium alloy with a large graft window and proprietary subtractive surface treatment technology. It is packaged sterile and supplied pre-loaded on a disposable delivery instrument. The DTRAX Spinal System-L is a single-use, disposable set of surgical instruments designed for cervical fusion and compatible with CAVUX Cervical Cage-L.

“I found the delivery of this new cage to be easier and more efficient than other options currently available for anterior cervical discectomy and fusion (ACDF),” said Dr. Kris Siemionow of the University of Illinois at Chicago after performing the first commercial use of the device. “The instruments in the new DTRAX Spinal System-L allowed me to deliver the device with fewer steps and in less time than the typical ACDF [procedure],” he added.

CAVUX Cervical Cage-L is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Providence’s family of products for cervical spine surgery now includes DTRAX Spinal Systems, CAVUX Cervical Cages, BIOLOGIX™ Allograft Bone, and ALLY™ Bone Screws.

“The launch of CAVUX Cervical Cage-L and DTRAX Spinal System-L represents an important step in broadening our platform of innovative, single-use instruments and implants for cervical fusion,” commented Jeff Smith, Chief Executive Officer of Providence Medical Technology. “We are committed to continuing to fill critical gaps in the continuum of traditional cervical spine care.”

About Providence Medical Technology, Inc.

Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company is focused on commercializing the DTRAX platform of single-use, tissue-sparing instruments and CAVUX implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients. For more information, visit www.providencemt.com.

DTRAX, CAVUX, BIOLOGIX, and ALLY are trademarks of Providence Medical Technology, Inc.

Video – http://origin-qps.onstreammedia.com/origin/multivu_archive/PRNA/ENR/CAVUX-Cage-L-Animation-Providence-Medical-Technology.mp4

SOURCE Providence Medical Technology, Inc.

Inaugural Lumbar Total Disc Replacement Summit Yields Surgeon Consensus on Lumbar TDR as a Standard of Care for Lumbar DDD

Posted On November 7, 2016 By OrthoSpineNews In Spine /

CENTER VALLEY, PA–(Marketwired – November 03, 2016) – Prior to the 31st Annual North American Spine Society (NASS) meeting in Boston, MA last week, a group of leading spine surgeons came together at the inaugural Lumbar Total Disc Replacement Summit. The goal of the Summit was to drive consensus on Lumbar Total Disc Replacement (TDR) as a standard of care for lumbar DDD in the active patient subpopulation and to ultimately influence payers to expand coverage of the procedure. The surgeons recognized motion-preserving TDR as a well-studied surgical treatment alternative to spinal fusion and collaborated on a review of the long-term evidence in support of lumbar TDR.

The 19-surgeon panel developed a general consensus on the patient groups who, based on the published long-term evidence, should have access to this procedure through their insurance companies. The panel cited lumbar TDR as the most studied spinal procedure with outcomes exceeding those of fusion, which is currently treated as the standard of care for this patient population.

Despite significant evidence available on the procedure, many insurance carriers have shown reluctance to adding lumbar TDR to their covered benefits. “There is a general lack of understanding by the payers of how well lumbar TDR has been studied and how positive the outcomes have been,” said Lynn Miller, MD, a neurosurgeon whose practice is focused on motion preservation in the Twin Cities. “Our panel group agreed that lumbar TDR does not add cost to the payer. We don’t understand why they are so reluctant to cover something where the patient benefit has been thoroughly demonstrated.”

The surgeon panel plans to publish the outcome of their discussion and share with payers in their regions to demonstrate how surgeons would responsibly utilize TDR as a treatment alternative to fusion.

Plans for the second Lumbar TDR Summit are underway for Spring 2017. The panel is looking for additional surgeons to join the movement and increase momentum of this procedure aimed at improving quality of life for chronic low back pain patients. The inaugural Lumbar TDR Summit was funded in part by Aesculap Implant Systems, LLC. The company is currently closing out a seven-year IDE study on its lumbar TDR device, activL® Artificial Disc.

Cornerstone Research Group was commissioned to employ a modified-Delphi process to reach consensus on the responsible use of TDR. The firm is currently pooling the existing five-year evidence on lumbar TDR from six randomized controlled trials into a meta-analysis.

Patients suffering from debilitating low back pain who have exhausted their non-surgical treatment options without finding relief for their pain often seek surgical procedures to stabilize their low back, thereby reducing pain and getting them back to a favorable quality of life. While the vast majority of spine surgeons first offer a spinal fusion to address this problem, long-term evidence demonstrates that for some patients, TDR is a better option because it comes closer to maintaining the natural physiologic movement of the healthy human back. In five-year studies, total disc replacement has demonstrated a threefold reduction from fusion in the rate of further degenerative disease at other motion segments in the spine.

About Aesculap Implant Systems, LLC

Aesculap Implant Systems, LLC, part of the B. Braun group of companies, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients’ lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com

CONTACT INFORMATION

Senior Project Manager, Corporate Communications
Aesculap Implant Systems, LLC
office: 610-984-9242
email: judy.marushak@aesculap.com

Medovex Corporation Announces Successful Largest Living Tissue Population Test to Date

Posted On November 3, 2016 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – Nov 2, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the company conducted a successful live tissue test of the DenerveX™ System under the most stringent standards required by FDA and other regulatory agencies.

Patrick Kullmann, Medovex President and COO, stated, “This latest testing of the DenerveX System is the largest living tissue population test to date. The results confirm that the DenerveX System delivers its intended treatment and that it supports the type of reimbursement that the company has already secured in its first targeted country, Germany.”

The GLP (Good Laboratory Practice) protocol testing consisted of a 12 porcine subject clinical evaluation of the DenerveX System at 0, 30 and 60 day time period post procedure. The total subject pool consisted of 144 treatments, of which 48 treatment sites were randomly selected and initially evaluated per the GLP.

Of the 48 evaluated treatments, 92% of the DenerveX System treatments reached their targeted facet joint treatment sites. Dorsal nerve roots and dorsal ganglia did not have evidence of neurodegeneration at the sites examined. No routinely examined organs had changes interpreted to be related to the study. All subjects survived the study to term absent complication.

Martin Deeg MD of Stuttgart, Germany an advisory board member with experience with the DenerveX System, reviewed the data and stated, “The DenerveX System delivered treatments that would be expected and desired as needed to provide longer term pain relief, and that would set up the DenerveX System and procedure as a new and unique therapy for Facet Joint Syndrome.”

Vik Kapoor MD of Manchester, England, also an advisory board member and equally experienced with the DenerveX System, added, “The DenerveX System proved out in the data that it will fundamentally change the way Facet Joint Syndrome will be treated in the future.”

Jarrett Gorlin, Medovex CEO, commented, “The DenerveX System represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Our future customers have commented their clear appreciation for our different approach in performing a new procedure by way of a posterior calsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy). This gives us cause for continued cautious optimism going forward.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX System is not yet CE marked or FDA cleared and is not yet commercially available. A full evaluation of the test results continues. The results of the test have not yet been submitted to, or evaluated by, the notified body or FDA for consideration and comment. There can be no assurance that the notified body or FDA will not have further questions or require additional information when it reviews the test results.

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

OrtoWay AB: OrtoWell® Distractor Tool from OrtoWay is Used Clinically for First Time in Lateral Spinal Surgery

Posted On November 2, 2016 By OrthoSpineNews In Spine /

November 02, 2016

STOCKHOLM–(BUSINESS WIRE)–Top German spine clinic reports successful application and ease of use for lateral MIS fixation in complicated surgical corpectomy.

OrtoWay AB, the Stockholm-based medical technology company, says its OrtoWell® device was used for the first time in a lateral, minimally invasive surgical (MIS) fixation procedure as part of a corpectomy at the renowned Dreifaltigkeits-Krankenhaus Clinic in Cologne, Germany. The CE-Marked device, now approved for most anterior-approach surgeries, was used to position an implant in a 39-year-old male patient suffering from inflammation in the L1 and L2 vertebra.

Quicker fixation with high accuracy

Developed in Sweden by a group of biomaterial and spinal experts, the OrtoWell device offers time-saving possibilities for surgeons, giving them more freedom and supporting fixation of the vertebra. The instrument fixates the vertebra in a unique way that allows for less complicated insertion of implants and can be used with any prosthesis. It is currently approved in Europe (CE Mark) and the US (Class 1 medical device), and was recently extended to include spinal tumor surgery.

Very good holding strength

“When replacing vertebra in the lumbar spine, it’s important to have tools that are easy to use and support accurate positioning and holding strength,” says Dr. Biren Desai, the leading spine surgeon who carried out the operation at the Dreifaltigkeits-Krankenhaus clinic. “Not only did the OrtoWell device help simplify the operation but I was impressed by the very strong, smooth hydraulic operation.” His clinic specializes in spine surgery, orthopedics and sports traumatology, treating 19,000 patients a year and carrying out more than 4,000 operations.

Novel hydraulically powered system

The OrtoWell Distractor is a novel hydraulically powered system that separates and holds apart vertebral bodies in the spinal column during anterior surgery. It consists of some non-disposable parts (distractor unit, spanner unit, retractors and frame, tools) as well as disposable components (tube unit, gauge, hooks, bone screws). The use of gentle, yet powerful incremental hydraulic force to prevent the vertebrae from collapsing or moving during operations is beneficial to surgeons since it facilitates correct positioning of spinal prosthetics such as disc implants and ALIF cages.

Many areas of potential usage

“We’re delighted to see this proof of successful usage of our device and believe it has the potential to become a successful tool for many aspects of spinal surgery,” says Stan Mikulowski, CEO of OrtoWay AB. Other possible areas of application include degenerated discs, tumor removal and various situations where vertebral distraction is required. “We are strongly committed to improving patient outcomes with the help of superior spinal technology,” he concludes.

About OrtoWay AB

OrtoWay AB was founded in 2006 by a group of experts in biomaterials, spinal surgery and medical technology who were looking for ways to improve anterior surgery and implantation of spinal prosthesis in the lumbar region. The developer behind the OrtoWell Distractor system, OrtoWay AB is today a Swedish privately held medical technology company that is seeking partners for commercialization. The OrtoWell instrument has CE marking for medical devices in Europe and is approved for usage as a Class 1 medical device in the USA. The product will be made available through OrtoWay LLC, an independent company based near Philadelphia, Pennsylvania, USA.

OrtoWay has received patents for this invention in Europe, the USA and in Australia.

OrtoWell is a registered trademark in the USA, EU and Australia.

Currently OrtoWay is looking for partners to commercialize this invention.

This information was brought to you by Cision http://news.cision.com

Contacts

To learn more about this product or to discuss partnerships, please contact:
Stan Mikulowski, CEO
Stan.mikulowski@ortoway.com
Cell phone: +46 708 769 991
From the US; 011 708 769 991
www.ortoway.com

Zimmer Biomet announces positive comparative seven-year Mobi-C data

Posted On November 2, 2016 By OrthoSpineNews In Spine /

29th October 2016

Zimmer Biomet has announced results of a seven-year outcomes study demonstrating statistical superiority of its Mobi-C cervical disc prosthesis versus two-level anterior cervical discectomy and fusion (ACDF) in overall success.

In the study, overall success required improvement in Neck Disability Index (NDI), no secondary surgical interventions at the index levels, and absence of major complications defined as radiographic failure, neurological failure or adverse events. Mobi-C was the first cervical disc prosthesis approved by the US Food and Drug Administration (FDA) for reconstruction of the cervical disc at both one and two levels, to treat severe pain in the neck or arm caused by various spine disorders or injuries. The data was presented at the annual meeting of the North American Spine Society (NASS; 26–29 October, Boston, USA).

The prospective, randomised, controlled trial was conducted as an FDA-regulated Investigational Device Exemption (IDE) clinical trial of the Mobi-C cervical disc. The trial compared outcomes including NDI, neck and arm pain as measured on the Visual Analog Scale (VAS) and patient satisfaction, between two-level cervical total disc replacement (cTDR) procedures and two-level ACDF procedures, over seven years. The authors conclude that Mobi-C at two contiguous levels continues to demonstrate superiority to ACDF in overall study success rates through 84 months.

“Comparing cTDR and ACDF in this prospective, randomised study with long-term follow-up, Mobi-C showed statistically significant better clinical improvement in general and disease-specific outcome measures compared to ACDF,” said Kris Radcliff, the lead author of the study and associate professor in orthopaedic surgery and neurosurgery at Thomas Jefferson University, Philadelphia, USA. “Further, significantly lower rates of subsequent surgery and adjacent segment degeneration were observed with Mobi-C at seven years.”

“Our seven-year data reinforcing the clinical utility of Mobi-C is not only an important milestone for this revolutionary device, but also further validation of the value of cervical motion preservation technology in treating severe pain in the neck or arm caused by various spine disorders or injuries,” said Adam Johnson, Zimmer Biomet’s group president of spine, dental, CMF and thoracic. “Mobi-C represents a critical pillar in establishing Zimmer Biomet as an emerging leader in spine health, and with the growing body of clinical and real-world evidence supporting its efficacy and safety, Mobi-C is poised to become the new standard of care for cervical disc replacement.”

HKJDC Limited Announces New Biomechanical Technology Invention From Hong Kong for Orthopedic Medicine

Posted On November 1, 2016 By OrthoSpineNews In Recon, Spine /

HONG KONG, Nov. 1, 2016 /PRNewswire/ — In the United States alone, an estimated 15 million fractures occurs annually, including 1.6 million hospital admissions for traumatic fractures and 2 million osteoporotic fractures, costing over 60 billion dollars and calling for 1.6 million bone grafts each year; a growing demand for bone grafts is similarly observed worldwide. Bone is the second most commonly implanted material in the human body, after blood transfusion. The science of bone grafts in nonunion and bone loss have been established and refined, and new methods of bone graft extraction that limits pain and complications for these treatments should be determined, developed and implemented for the minimally invasive treatment advantages. A passive and effortless percutaneous method providing full control and precision for the endeavor would be supreme.

A “Bone Graft” is the basic ingredient and the basis of almost every major reconstructions for many orthopedic and spinal disorders which include deformities, degeneration, fractures and damages. Degenerative Disc Disease (DDD) commonly known as ‘slipped disc’, scoliosis, spondylolisthesis, spinal stenosis, and vertebral fractures all require a spinal fusion treatment using a “Bone Graft”. According to the WHO Low Back Pain (LBC) is the number 1 cause of disability worldwide, and together with the treatments for severe neck pain, nonunion fractures of long bones, cranial maxillofacial fractures commonly consequent to automobile accidents and so on, they all firstly require a “Bone Graft” to repair the patient. Without a “Bone Graft”, none of all these conditions can be suitably treated. The increased prevalence of spinal fusion surgery alone has created an industry focus on bone graft alternatives. While autologous bone graft, also known as autograft – the patient’s own solid living bone tissue usually extracted from the hips remains the gold standard, but the pain and complications from extracting autologous bone graft, the problems with open surgery extraction drives the endless search for a reliable and safe bone graft substitute product. Many approaches are used in the repair of skeletal defects in reconstructive orthopedic surgery, and bone grafting is involved in virtually every procedure. Autografting (live bone extracted from the patient) remains the gold standard for replacing bone loss. Moreover most alternatives, including bone bank which bear contamination, artificial discs and stem cell products are expensive and mostly not compatible nor validated by Evidence based medicine EBM, thus being scarcely recommendable for clinical use. The search for alternative biomaterials for a bone graft continues.

This new surgical tool holds the United States Patent Number: 8920423 December 30, 2014 by Inventor : Dr. Benjamino Kah Hung Lee. It was first conceived, initiated and collaborated with The Government of the HKSAR (supported via The Hong Kong Productivity Council), and was presented at The Hong Kong Hospital Authority at their Annual Convention on 7th May, 2014.

After initial tests on animal bone, currently top USA scientists and surgeons at Barrow Neurological Institute in Phoenix, Arizona in the United States are preparing to conduct a Biomechanical Study to translate and introduce this surgical tool into the medical industry for clinical use. (Barrow Neurological Institute is the world’s largest neurological disease treatment and research institution, and is consistently ranked as one of the best neurosurgical training centers in the United States). This new surgical tool is not available from any manufacturers and offers many new advantages which are equally applicable in many fields of medicine including for the spine and also for many other procedures; orthopedic surgery, spinal surgery, plastic surgery, cranial maxillofacial surgery, dentistry and dental implantology. A growing market for an aging population. Currently we are ready to manufacture the tool and a Gant Chart scheduled for the production process which will require 15-18 months to complete. We have two large hospitals in China interested to work together with us in using the surgical tool we developed for live bone extraction. One hospital group has orthopedic hospitals in Guangzhou and Wuhan. The second one is in Dalian port in Liaoning Province. All these 3 cities are important healthcare centers with enormous popularity with Chinese patients. While orthopedic surgeries, including spinal fusion and non-union fractures as well a host of degenerative bone ailments are currently being treated, their standards and quality of care and recovery has much room for improvement. Both groups are very excited about the potential of introducing new tools and procedures into China. We were also told that the demand for re-constructive surgery, dental implants has grown rapidly in recent years due to aging population. The China hospitals also explained that since this is a virgin territory without competition, it is possible to set up a “separate foundation specifically categorized for this tool and its novelty technique” to look into various limitless applications of this proven surgical percutaneous procedure for the direct transfer of bodily tissues and to popularize it in China for the beneficial sake of patients among the Chinese physicians and orthopedic surgeons, especially for how exactly to get a piece of live bone with effortless ease, remarkable expediency to save operation theatre time, and minimal discomfort, minimizing the risks of complications, reduce blood loss and reduce pain for an uneventful recovery.

The level of interest is for knowing that if this percutaneous approach can be installed, then ALL of the currently available known approaches for the reconstructions would bear far greater risks of complications overall, in addition to their greater time and costs involved, nevertheless.

In view of this, it is for certain that all the efforts of all persons interested to be pioneers in this medical field by joining in with our scientific team for collaborating with more biomechanical studies, beginning in USA and China will be immortalized, and to publish scientific documents under their names.

For further information and technical specifications, FDA details, engineering details, about this new orthopedic instrument, please contact: Dr. Benjamino Lee at hkjdcl@hotmail.com or please feel free to call Tel : 852-2808-4768 for press information.

For scientific information and the biomechanical study details, with potential interest to join our scientific team for biomechanical study side, please contact:

Dr. Brian P. Kelly phD, Director of Spine Biomechanics Laboratory
Barrow Neurological Institute, Department of Neurosurgery,
350 West Thomas Rd, Phoenix, Arizona, United States.
Email: Brian.kelly@dignityhealth.org

For investors who are interested in equity side, please contact our company with the IPR, and welcome to contact our CEO Dr. Ting Ho at QiBiotech Company for funding opportunity and business discussions.

QIBIOTECH COMPANY LIMITED

Room 510, 5th Floor, K. Wah Centre, 191 Java Road, North Point, Hong Kong.
Email:tingho@qibiotech.com Tel: +852 2765 8500 Fax: +852 2765 8555

This content was issued through the press release distribution service at Newswire.com. For more info visit: http://www.newswire.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/hkjdc-limited-announces-new-biomechanical-technology-invention-from-hong-kong-for-orthopedic-medicine-300354798.html

SOURCE HKJDC Limited

PR Newswire
www.prnewswire.com

Last updated on: 01/11/2016

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In’Tech Medical’s Wayvio line of intelligent surgical instruments for orthopedics

Posted On November 1, 2016 By OrthoSpineNews In Extremities, Spine /

November 1, 2016

Memphis, Tennessee – In’Tech Medical SAS, a world leader in contract manufacturing of surgical instruments in orthopedics, announced the launch of its new Wayvio platform, dedicated to enhancing standalone surgical instruments with smart communication tools.

“With the launch of Wayvio, In’Tech Medical continues to drive innovation and set new standards in the world of Orthopedics,” says Laurent Pruvost, president. He adds “The Wayvio technology strikes a new balance between manufacturing excellence and electronics, enabling OEMs and medical staff to achieve more than what they ever thought possible with a surgical instrument. It is fulfilling for the In’Tech Medical team across the world – U.S., Europe, and Asia, to bring to market a technological platform that will help our customers as well as hospitals and surgery centers optimize their logistics while keeping in tune with their instruments & trays.”

The Wayvio technology can be retrofitted and integrated into almost any instrument, instantaneously turning it into a powerful wireless device. Transparent for the surgeon or medical staff, instruments bearing the Wayvio technology will seamlessly store and communicate key parameters, such as number of sterilizations, helping with data exchange between OEMs, medical staff, and sales reps.

“By facilitating traceability, and increasing accountability as well as efficiency, the Wayvio technology decreases the collateral risks associated with any instrument’s life-cycle,” said Patrick Khalife, R&D director. “The Wayvio on board electronics are self-triggered throughout the instrument’s life-cycle with no human interaction. Specific data points, such as number of sterilization or amount of torque “clicks” are collected and can wirelessly be accessed through an intuitive Android-based NFC reader. It truly is a game changer.”

Wayvio allows OEMs, hospitals and all actors in supply chain to stay in tune with their surgical instruments. By accessing its core, they can monitor at any time occurrences such as:

Frequency of OR (ie. operation room) exposure
Recurrence of surgical use (ie. impaction, torque limiting “click,” etc.)
History of inadvertent events such as accidental dropping of instruments or tray, and out of range impaction or strains

As an adaptable platform, Wayvio’s applications are virtually limitless with possibility to geotag last known connection of a device or adding notes post-operative comments.

About In’Tech Medical
Founded in France in 2000, In’Tech Medical is a global leader in orthopedic contract-manufacturing. With the company’s recent expansion in USA and Malaysia, In’Tech Medical is now the world’s largest provider of surgical instruments to the Spine Industry. Powered by a diverse product portfolio, an ability to find solutions to complex engineering challenges, and over 500 employees globally, In’Tech Medical is ideally positioned for sustainable growth and personalized customer care.

In’Tech Medical is also home to The Prototype Garage – prototype dedicated cells located both in Europe & the US, with the intent of serving industry with production-equivalent prototypes in a rapid-delivery setting.

Source: www.intech-medical.com

DePuy Synthes Spine introduces new lower back implant that promotes fusion, restores function

Posted On November 1, 2016 By OrthoSpineNews In Spine /

October 31, 2016

Today DePuy Synthes Spine, Part of the Johnson & Johnson Family of Companies, launched the SYNFIX^® Evolution System, a new implant for stand-alone Anterior Lumbar Interbody Fusion (ALIF). The SYNFIX Evolution System delivers biomechanical stability to promote fusion and restore function, coupled with instrumentation designed to optimize surgical workflow. The System offers a broad range of implant options to accommodate a variety of patient anatomies.

The use of stand-alone ALIF, in which the spine is accessed through the abdomen, is growing at a rate of three percent each year globally thanks to reduced complication rates compared to fusion surgery performed through the patient’s back. Multiple studies of SYNFIX^® Implant technology show that it provides superior biomechanical stability compared to other stand-alone ALIF implants and equivalent biomechanical stability relative to lumbar fusion performed through the back.

“Biomechanical stability in an implant is paramount,” said Alexandre Rasouli, MD, Cedars-Sinai Medical Center. “It is the difference between a single stage surgery and a more involved multi-stage surgery that can increase complications and drive up costs.”

The SYNFIX Evolution System consists of a PEEK spacer coupled with a titanium zero-profile plate and four divergent locking screws, which create a wedge of bone that helps anchor the implant during the healing process. The range of implant options allows the surgeon to accommodate varying patient anatomies and restores spine balance. The SYNFIX Evolution System increases surgical efficiency by reducing the number of instruments and increasing screw insertion speed. The SYNFIX Evolution System design team engineered an innovative thread lock sleeve to capture the screw to the screwdriver, preventing the screw from becoming disengaged during surgery.

“DePuy Synthes has been a leader in providing solutions for stand-alone ALIF procedures for more than a decade, and we are committed to investing in this market to ensure we continue to meet the needs of our customers and patients,” said Dan Wildman, Platform Leader, DePuy Synthes Spine. “The launch of the SYNFIX Evolution System shows that we continue to respond to our customers by developing a product that is easy to use while helping improve operating room efficiency.”

Source:

http://www.depuysynthes.com/

Misonix Hands-On Lab Generates Strong Interest in BoneScalpel® at NASS

Posted On October 31, 2016 By OrthoSpineNews In Spine /

FARMINGDALE, N.Y., Oct. 31, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, recently participated in the North American Spine Society (NASS) 2016 Annual Meeting in Boston, MA from October 26-29.

NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, and evidence-based spine care. The NASS 2016 Annual Meeting represented the largest spine meeting and exhibit in the world. It was attended by thousands of spine surgeons gathered to discuss new innovative options, trends, and outcomes in spine surgery.

While at the Misonix exhibit meeting attendees engaged with leading surgeons, including Dr. Nicholas Renaldo, Medical Director of Spine Surgery at Vassar Brothers Medical Center, Poughkeepsie NY; Dr. Eric Woodard, Chief of the Section of Neurosurgery, New England Baptist Hospital, Boston MA; and Dr. Connor Telles from Sierra Pacific Orthopedics in Fresno, CA, to learn about their surgical experiences with the BoneScalpel.

Misonix also hosted – by invitation only – several leading surgeons in the “Innovation Room” where the invited surgeons met with members of the Misonix engineering group to learn more about future innovations under development. Gaining feedback directly from the surgeons at the event is a critical step in assuring that the next generation technologies under development reflect end-user recommendations.

In addition to the Company’s booth presence, Misonix hosted a BoneScalpel hands-on cadaveric workshop entitled, Ultrasonic BoneScalpel Techniques in Complex Spine facilitated by Isador Lieberman, MD, Director of the Scoliosis and Spine Tumor Center at the Texas Back Institute in Plano, TX. Dr. Lieberman demonstrated his clinical usage of the BoneScalpel with attendees having the opportunity for trialing the BoneScalpel ultrasonic bone-cutting instrument. More than 35 spine surgeons were trained on the use of BoneScalpel at the lab.

Commenting further on the week’s events was Dr. Juan Uribe, University of South Florida, Tampa, FL, who presented his experience with the BoneScalpel at Friday’s NASS Solutions Showcase. “The advantages of less blood loss, precise cuts, savings in operating room time, and less hand fatigue are among the many reasons that BoneScalpel is now a requirement for a high percentage of the cases I currently perform. In fact, BoneScalpel has changed the way I practice spine surgery,” added Dr. Uribe.

Stavros Vizirgianakis, interim chief executive officer of Misonix, said, “We are gratified that these key opinion leaders in the spinal and neurosurgical space have adopted our technology into their practices and enthusiastically share their expertise and experiences with others in their profession. This is a very positive reflection on the efficacy of the BoneScalpel, our ultrasonic technology, and the skill sets of these surgical professionals to produce improved patient outcomes, and to do so, in a very efficient manner. We are pleased to be associated with these leading surgical professionals.”

Dr. Isadore Lieberman, who facilitied the BoneScalpel cadaveric workshop, said, “I was extremely pleased with the turnout for the workshop and the continued high level of interest in the BoneScalpel by my peers and colleagues at this year’s NASS meeting. In my opinion, BoneScalpel continues to be one of the most important innovations in spine surgery in the past several years and given the number of attendees who participated in the workshop this year, clearly people are taking notice of the importance of this technology.”

Misonix Senior Vice President of Global Sales and Marketing, Scott Ludecker, commented, “BoneScalpel’s ability to mitigate the potential for soft tissue collateral damage and minimize blood loss during complex spine surgeries are some of the key benefits which have drawn the spinal surgeon community to BoneScalpel. These attributes are universally understood as being cornerstones for better patient outcomes. Events like this week’s hands-on cadaver workshop are idea forums for surgeons to experience for themselves the benefits of our technology. Having leading surgeons like Dr. Lieberman available to share his personal experience with them is invaluable.”

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact	Investor Contact
Misonix Contact:	Joe Diaz
Richard Zaremba	Lytham Partners
631-694-9555	602-889-9700
invest@misonix.com	info@misonix.com

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SOURCE Misonix, Inc.