Archive for ‘spinal surgery’

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Hip prosthesis lasts for over 20 yearsHip prosthesis lasts for over 20 years

Hip prosthesis lasts for over 20 years

The Zweymüller prosthesis, developed at the end of the 1970s, was one of the first to be anchored in the bone without using bone cement to fix it in place. The prosthesis’s special geometry and surface guarantee its stable anchoring and natural integration into the bone. Its hallmark feature is the roughened surface of the stem, which provides a place for the new bone tissue to grow onto.

In the past, the endoprosthesis has been made from ultra-lightweight titanium, has been implanted millions of times over, and has even been used in minimally invasive procedures with an incision in the skin measuring around ten centimetres. Nowadays, it is used in combination with a ball and socket made from ceramic, which produces less wear. In 67 per cent of the 200 test subjects investigated, the durability of the ball and socket, i.e. the second outcome of the study, which has now been published in the highly respected journal “The Journal of Bone and Joint Surgery”, is still intact after 20 years.

Around 300 total hip replacements are carried out at the University Department of Orthopaedics at the MedUni Vienna / Vienna General Hospital every year, half of them involving Zweymüller prostheses. Patients are even able to carry out sports without impacting on the durability of the prosthesis or causing it to loosen any sooner. Patients are becoming younger and younger – particularly in light of the prosthesis’s excellent quality. In the past, says Windhager, the average age of patients receiving hip replacements was significantly higher than 65 years, but nowadays it continues to fall below this.

Research into even better integration of prostheses

The Department of Orthopaedic Surgery at the MedUni Vienna is also carrying out research into the development of new, even better prostheses using the so-called radiostereometric analysis (RSA). Says Windhager: “The movement of the implant relative to the bone is measured in three dimensions. We are able, as it were, to watch the implant while it moves. We achieve accuracies of up to 0.1 millimetres.” Within the first two years after the operation, this means that it is possible to obtain an early diagnosis of how the implant is integrating into the bone and of its durability. RSA also allows new materials that are used for the new types of prosthesis – including of the knee, foot or spine – to be compared with each other.

“RSA is the ideal tool for the development of new products in orthopaedic surgery. Our aim is to further improve the integration of the implant into the bone. The biology is especially important here; we’re able to see what’s happening around the prosthesis,” says the Head of Department.

Source : http://www.news-medical.net/news/20121203/Hip-prosthesis-lasts-for-over-20-years.aspx

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Medtronic Laounches SOLERA Spinal Implant System

Medtronic Laounches SOLERA Spinal Implant System

Medtronic Laounches SOLERA Spinal Implant System

Continuing a stream of recent advancements for stabilization of the spine, Medtronic, Inc. (NYSE: MDT) today announced both the release of its CD HORIZON® SOLERA™ Spinal System in the U.S. and a limited market release in Japan. This product launch is part of the CD HORIZON® family of fixation devices, designed to provide spinal stabilization and correction as an adjunct to fusion in patients suffering from painful and function-limiting disorders of the middle and lower back.

The CD HORIZON® SOLERA™ Spinal System is designed to be compatible with Medtronic’s proprietary minimally invasive technologies, known as MAST™. It also is unique in that it is integrated with Medtronic’s surgical navigation and imaging systems and the NIM-ECLIPSE™ neuromonitoring system. This allows for decreased exposure to radiation for hospital staff, and improved accuracy of device placement to avoid injury to nerves. The system accommodates multiple rod material options, allowing choice in rod flexibility and strength to match the demands of a variety of spinal conditions. Additionally, smaller implants may provide the advantages of increased room for bone graft required for fusion, and reduced impingement on the facet joints. The facet joints are the small stabilizing joints located at the intersection of adjacent vertebrae.

In addition, Medtronic is working to improve patient care and hospital efficiencies by offering a complete solution for electronically tracking specific implants to individual patients. The CD HORIZON® SOLERA™ Spinal System implants are equipped with VERIFYI™ Implant Tracking System technology, which is similar to barcode technology, and provides device quality and utilization-related data for customers in a manner that meets anticipated FDA requirements for unique device identification (UDI).

“The launch of the CD HORIZON® SOLERA™ Spinal System is a key step in renewing our global fixation business, bringing new innovation to the market and extending our industry-leading portfolio of spinal therapies,” says Doug King, Vice President and General Manager of the Spine business at Medtronic. “This launch builds on other recent advances in spinal fixation, including the releases of the VERTEX SELECT™ Reconstruction System and the TSRH® 3Dx™ Spinal System, and serves as a foundation enabling Medtronic to continue to deliver meaningful advances in spine care.”

About the CD HORIZON® SOLERA™ Spinal System

The CD HORIZON® SOLERA™ Spinal System is Medtronic’s fifth generation spinal fusion system and is cleared to treat patients with degenerative disc disease, spinal stenosis, fracture, dislocation, failed previous fusions, tumors and, uniquely, adolescent idiopathic scoliosis. Extending the unmatched clinical history of more than twenty-five years and 500,000 patients represented by the CD HORIZON® product line, the CD HORIZON® SOLERA™ Spinal System offers the important combination of lower profile pedicle screw implants and performance. Enabling features include the OSTEOGRIP® thread pattern for enhanced fixation at the bone-implant interface, and a patented “closure mechanism,” or means of connecting to a variety of implants in a streamlined fashion. Notably, the system accommodates multiple rod material options and gives surgeons and hospitals an array of choices to treat a diverse set of spinal conditions.

Risks associated with such a system include loosening, disassembly, bending, and/or breakage of components, fracture, microfracture, resorption, damage, or penetration of any spinal bone. Selection of the proper size, shape, and design of the implant for each patient is crucial to its safe use. A successful result is not always achieved in every surgical case. The safety and effectiveness of this device has not been established for use as part of a growing rod construct when used in pediatric cases, and is only intended to be used when definitive fusion is being performed at all instrumented levels.

About the Spine Business at Medtronic

The Spine business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spine business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopaedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Medtronic is launching its CD HORIZON SOLERA spinal implant in the US and in a limited release in Japan. The device is meant to be used in conjunction with a fusion to provide greater stabilization of the spine in patients with more acute mid to lower back problems.

The CD HORIZON® SOLERA™ Spinal System is designed to be compatible with Medtronic’s proprietary minimally invasive technologies, known as MAST™. It also is unique in that it is integrated with Medtronic’s surgical navigation and imaging systems and the NIM-ECLIPSE™ neuromonitoring system. This allows for decreased exposure to radiation for hospital staff, and improved accuracy of device placement to avoid injury to nerves. The system accommodates multiple rod material options, allowing choice in rod flexibility and strength to match the demands of a variety of spinal conditions. Additionally, smaller implants may provide the advantages of increased room for bone graft required for fusion, and reduced impingement on the facet joints. The facet joints are the small stabilizing joints located at the intersection of adjacent vertebrae.

In addition, Medtronic is working to improve patient care and hospital efficiencies by offering a complete solution for electronically tracking specific implants to individual patients. The CD HORIZON® SOLERA™ Spinal System implants are equipped with VERIFYI™ Implant Tracking System technology, which is similar to barcode technology, and provides device quality and utilization-related data for customers in a manner that meets anticipated FDA requirements for unique device identification (UDI).

The CD HORIZON® SOLERA™ Spinal System is Medtronic’s fifth generation spinal fusion system and is cleared to treat patients with degenerative disc disease, spinal stenosis, fracture, dislocation, failed previous fusions, tumors and, uniquely, adolescent idiopathic scoliosis. Extending the unmatched clinical history of more than twenty-five years and 500,000 patients represented by the CD HORIZON® product line, the CD HORIZON® SOLERA™ Spinal System offers the important combination of lower profile pedicle screw implants and performance. Enabling features include the OSTEOGRIP® thread pattern for enhanced fixation at the bone-implant interface, and a patented “closure mechanism,” or means of connecting to a variety of implants in a streamlined fashion. Notably, the system accommodates multiple rod material options and gives surgeons and hospitals an array of choices to treat a diverse set of spinal conditions.

source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1296099574673&lang=en_US

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Medtronic’s Aquamantys SBS 5.0 Sheathed Bipolar Sealer Cleared in U.S. for Spinal Surgeries

Medtronic’s Aquamantys SBS 5.0 Sheathed Bipolar Sealer Cleared in U.S. for Spinal Surgeries

Medtronic’s Aquamantys SBS 5.0 Sheathed Bipolar Sealer Cleared in U.S. for Spinal Surgeries

MINNEAPOLIS – January 23, 2012 – Medtronic, Inc. (NYSE: MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company’s Advanced Energy business.

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products,” said Mark Fletcher, President of the Surgical Technologies business at Medtronic, Inc. “The SBS 5.0 utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery, and it will deliver considerable value to surgeons, patients, and hospitals alike.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Medtronic received FDA 510(k) clearance to market its Aquamantys SBS 5.0 Sheathed Bipolar Sealer for sealing soft tissue and epidural veins during spinal surgery.

The device delivers RF energy for cauterization and saline to keep the area clean and clear for easy access around sensitive tissue.

From the press release:

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

Source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1327328898338&lang=en_US

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Mouse Spinal Cord Gene Map Goes Online

Mouse Spinal Cord Gene Map Goes Online

Mouse Spinal Cord Gene Map Goes Online

The Allen Institute for Brain Science is making publicly available its genome-wide map of expressions of spinal cord genes.

From the institute:

Since mice and humans share 90 percent of genes, and the mouse is a well-established model for the study of human diseases, the Allen Spinal Cord Atlas will provide scientists and physicians with an expanded foundation of knowledge to discover new treatments for numerous diseases and disorders. The Allen Spinal Cord Atlas will utilize the same concept and technology as the Institute’s inaugural Allen Brain Atlas.

From start to finish, the Allen Spinal Cord Atlas will be completed within a swift, twelve-month timeframe. While inaugural data—approximately 2,000 genes—from the Allen Spinal Cord Atlas is now available, the Institute will continue to follow its founding mission and upload additional information until the projected completion in early 2009. It is estimated that hundreds of users from universities, research institutes, pharmaceutical companies and government organizations will use the atlas.

When completed, the Allen Spinal Cord Atlas will detail approximately 20,000 genes including data from youth and adult developmental stages. It will also feature data across the full length of the spinal cord as well as anatomical reference sections.

source : http://www.alleninstitute.org/Media/documents/press_releases/Spinal_Cord_Atlas_Press_Release_07-17-08.pdf

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New image guided instrumentation for DePuy Synthes Spine’s leading spine systems

New image guided instrumentation for DePuy Synthes Spine’s leading spine systems

DePuy Synthes Spine announced new image guided instrumentation for two of its leading spine systems and has entered into a new partnership agreement with Brainlab, enabling both companies to offer integrated surgical navigation and imaging solutions.

The announcement was made here at the North American Spine Society (NASS) 27th annual meeting, where the company is featuring its broad portfolio of minimally invasive and traditional spinal surgery solutions.

“We believe the use of our instrumentation with Brainlab’s imaging and navigation solutions will be highly attractive to customers globally,” said Namal Nawana, Worldwide President, DePuy Synthes Spine. “This partnership is the latest example of how our new company is providing procedural solutions that deliver benefits to patients, physicians, providers, payers and policy makers.”

At NASS, DePuy Synthes Spine is featuring newly developed image guided instrumentation for its VIPER® 2 Pedicle Screw Fixation System for minimally invasive surgery and EXPEDIUM® Spine System for open surgical procedures. The new instrumentation, which includes awls, probes, taps, screw inserters and Jamshidi needles, has been integrated with Brainlab’s computer software. Additional image guided and surgical navigation systems are expected over the next several months.

“The partnership with DePuy Synthes Spine will allow us to integrate our technology seamlessly in surgical procedures and therefore provide an unmatched product offering to our combined customers,” said Stefan Vilsmeier, CEO and President of Brainlab.

Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment.

About DePuy Synthes Spine

DePuy Synthes Spine has one of the largest and most diverse portfolios of products and services in spinal care and is a global leader in traditional and minimally invasive spine treatment. The company offers procedural solutions for the full spectrum of spinal disorders including adult and adolescent deformity, spinal stenosis, trauma and degenerative disc disease. DePuy Synthes Spine is part of DePuy Synthes Companies of Johnson & Johnson, the largest provider of orthopaedic and neurological solutions in the world. For more information visit, www.depuysynthes.com.

Source : http://www.news-medical.net/news/20121102/New-image-guided-instrumentation-for-DePuy-Synthes-Spinee28099s-leading-spine-systems.aspx

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Diffusion tensor imaging detects complex muscle structures in 3D

Diffusion tensor imaging detects complex muscle structures in 3D

Eindhoven University of Technology (TU/e) and the Academic Medical Center (AMC) in Amsterdam have together developed a technique that allows detailed 3D imaging of complex muscle structures of patients. It also allows muscle damage to be detected very precisely. This new technique opens the way to much better and more patient-friendly diagnosis of muscular diseases. It also allows accurate, non-invasive muscle examinations among top athletes. Martijn Froeling received a PhD for this research at TU/e on Monday 29 October.

Froeling uses diffusion tensor imaging (DTI), an MRI technique that allows the movements of water molecules in living tissue to be viewed. Because muscles are made of fibers, the movements of water molecules in the direction of the fibers are different from those in other directions. This characteristic allows muscles to be imaged with a high level of detail. This was already possible on a small scale with simple muscles, but thanks to Froeling’s work it can now also be done on a larger scale and with complex muscle structures. More importantly, this improved technique also reveals very small muscle damage, because of the different movements of the water molecules in damaged muscle fibers.

3D images

To reach these results, Froeling improved the data acquisition process – the way the MRI scanner images the muscle under examination. This has to be performed relatively quickly, because it is uncomfortable for patients to lie in an MRI scanner for a long time, but at the same time it has to provide sufficiently detailed data. He also improved the processing of the acquired data into reliable 3D images. Physicians can now easily view complex muscle structures from all angles on-screen. No new equipment was needed; the researchers used standard widely available clinical systems.

Marathon runners

As a practical study, Froeling imaged a range of subjects including the thighs of marathon runners at different times: one week before a marathon, two days after it, and again three weeks after. He was able to visualize the muscle damage following the marathon. This was still visible after three weeks, even though the runners themselves in many cases no longer reported any pain in their muscles. Another study was of the pelvic floor in women; a good example of a highly complex muscle structure. The technique has proved to be capable of imaging this structure with great accuracy, which makes it potentially very valuable for the diagnosis of conditions such as uterine prolapse.

Wide application area

AMC Amsterdam and TU/e now intend to use this technique in studies of post polio syndrome and spinal muscular atrophy. Froeling believes there are numerous potential applications: there are around 600 different types of muscle disease and damage, and the new technique will improve the ability to study these. However further studies will first be needed: although the technique allows muscle disease or injury to be imaged it does not reveal the precise cause, which may be tearing, fat infiltration or other abnormalities. Clarification is also still needed on what are the normal values for healthy men and women of different ages, to provide a reference framework for identifying abnormalities in different groups of patients. Another kind of application is in examinations of top athletes, to allow timely detection of muscle damage or better estimation of the recovery time needed after injuries.

source : http://www.news-medical.net/news/20121031/Diffusion-tensor-imaging-detects-complex-muscle-structures-in-3D.aspx

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FDA Approves Clinical Trial for DIAM Spinal Stabilization System

FDA Approves Clinical Trial for DIAM Spinal Stabilization System

FDA Approves Clinical Trial for DIAM Spinal Stabilization System

Medtronic Inc. announced that it has received an investigational device exemption for its DIAM™ Spinal Stabilization System for use in a clinical study. This allows Medtronic to begin the first of three clinical trials in the US and Europe. The DIAM System was developed to reduce pain in degenerative stenosis patients who predominantly suffer from “radiating leg discomfort and moderate low back pain and is the only non-rigid interspinous spacer under clinical investigation.”

Here’s more about the study and the device:

The initial Medtronic study will examine the safety and effectiveness of the DIAM System when used to treat patients with degenerative stenosis. Degenerative stenosis is a common condition in the aging process, marked by the gradual narrowing of the spinal canal, resulting in pressure on the spinal cord or nerve roots.

Degenerative stenosis affects more than 250,000 U.S. patients each year. Stenotic spine patients with radiating leg pain or numbness typically undergo decompression surgery alone. Patients with both leg and back pain normally have a decompression surgery with fusion. The purpose of decompression surgery is to release excess pressure by creating more space in the spinal canal. Combined with decompression, the DIAM System could offer patients with leg and back pain a minimally invasive alternative to spinal fusion.

The implant is placed between the spinous processes (the visible ridges of the back) to act as a shock absorber that reduces loads on the surrounding vertebrae and restores the natural function of the joint. The core of the DIAM System is made of silicone, while the outer mesh and tethers are made of medical-grade polyester. The flexible properties of the DIAM materials may also protect the integrity of the spinous process.

Source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1152546870993&lang=en_US

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DSM extends license to supply CarboSil® TSPCU for use in AxioMed Spine Corporation’s Freedom® Spinal Discs

DSM extends license to supply CarboSil® TSPCU for use in AxioMed Spine Corporation’s Freedom® Spinal Discs

DSM, a global leader in biomedical materials sciences, and AxioMed Spine Corporation, an innovator in the field of spinal implant devices, today announced that they have revised and extended an existing licensing and supply agreement. DSM will supply its proprietary CarboSil®Thermoplastic Silicone-Polycarbonate-urethane material for use in AxioMed’s Freedom® Lumbar and Freedom® Cervical Discs.

Symptomatic degenerative disc disease is one of the most common causes of low back pain and occurs when the intervertebral discs in the spine degenerate and lose flexibility, elasticity and shock absorbing characteristics. Treatment options include spinal fusion and total disc replacements (TDRs), the use of which have grown rapidly in part due to the increasing sophistication of the devices used in the procedures. In the United States, for example, more than 570 thousand spinal fusion procedures were performed in 2011, a 4.9% increase over 2010, according to the Millennium Research Group. Growth in TDR procedures has been even more dramatic, with nearly 20 thousand procedures performed in 2011, which represents an 11.9% increase over 2010 numbers. Spinal fusion joins two or more vertebrae together, immobilizing the faulty vertebrae and eliminating pain caused by abnormal motion. TDRs are designed to replace degenerated discs and allow motion in faulty vertebrae, which can lead to diminished disability and faster recovery times. TDRs also prevent the premature breakdown of discs in adjacent levels of the spine, a potential risk in fusion surgeries.

The first generations of TDRs were a ball and socket design using metal on metal materials. As the implants evolved, new materials were incorporated into their design including polymers. DSM’s CarboSil® TSPCU is an advanced copolymer that combines the biocompatibility and biostability of conventional silicone elastomers with the processability and toughness of thermoplastic polycarbonate-urethanes. The material can improve in vitro and in vivo stability and helps prevent oxidative degradation, which can lead to improved patient results and longer lasting implants. The load bearing qualities of CarboSil® TSPCU help secure the total disc replacement device in place as it flexes with the natural movement of the spine. DSM’s novel materials designed specifically for the spinal market are incorporated in three TDR devices, as well as eleven dynamic stabilization applications with additional applications in development

“Spinal fusion has been the standard of care for degenerative disc treatment, but recently payer groups and insurance companies have begun lowering reimbursements for fusion procedures and questioning its cost and applications to certain patient groups,” said William Fuller, Director of BusinessDevelopment, Orthopedics at DSM Biomedical. “This creates an opportunity to highlight the benefits of total disc replacements and DSM material technology as AxioMed’s Freedom® Lumbar Disc undergoes clinical trials in the United States.”

AxioMed first introduced the Freedom® Lumbar Disc and the Freedom® Cervical Disc in Europe and received CE Mark approvals in May 2009 and May 2012, respectively, which proved instrumental in the Freedom® Lumbar Disc device becoming the first elastomeric disc to receive an Investigational Device Exemption (IDE) from the U.S. FDA. The disc is currently under evaluation in an ongoing multi-center U.S. and EU IDE pivotal clinical study designed with efficacy, safety and economic endpoints.

“The viscoelastic material properties of CarboSil® TSPCU and proven track record of DSM’s technology are ideal for our spinal discs,” said Patrick McBrayer, AxioMed’s President and CEO. “Our aim is to provide patients with pain relief, reduced disability and improved lifestyle by combining our companies’ innovations.”

DSM – Bright Science. Brighter Living.™

Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM’s 22,000 employees deliver annual net sales of around €9 billion. The company is listed on NYSE Euronext. More information can be found at www.dsm.com.

About AxioMed Spine Corporation

AxioMed’s mission is to develop products focused on spinal function for patients with degenerative spine disease, thus advancing the standard of care beyond fusion and first generation discs. The Freedom® Lumbar and CervicalDiscs have been developed and designed by a team of clinicians and experts in the fields of biomechanics, pathology, spinal surgery and polymer science. Focusing on restoration of the natural function of the spine, AxioMed will enhance human health through research, innovation, development and service world-wide. For more information about AxioMed, please visit our web site at www.axiomed.com.

Source : http://www.news-medical.net/news/20121024/DSM-extends-license-to-supply-CarboSilc2ae-TSPCU-for-use-in-AxioMed-Spine-Corporatione28099s-Freedomc2ae-Spinal-Discs.aspx

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ACIS Anterior Cervical Interbody Spacer System launched by DePuy Synthes Spine

ACIS Anterior Cervical Interbody Spacer System launched by DePuy Synthes Spine

DePuy Synthes Spine today announced the launch of the ACIS Anterior Cervical Interbody Spacer System (ACIS System), a comprehensive set of spacers and instrumentation for anterior cervical discectomy and fusion (ACDF).

The announcement was made here at the North American Spine Society (NASS) 27 annual meeting, where the company is featuring the ACIS System alongside the ZERO-P VA, a new zero-profile stand-alone two variable angle screw construct for ACDF that was launched earlier this year.

“Each of these new systems addresses different surgical and clinical needs of patients with degenerative disc disease in the cervical spine, a major focus of innovation for us,” said Namal Nawana, Worldwide President, DePuy Synthes Spine.

ACIS System spacers are offered in three axial footprints (12.5mm, 14mm or 16mm widths), eight heights (5mm – 12 mm) and three sagittal profiles (lordotic, parallel or convex) to accommodate individual patient anatomy and surgical techniques. The spacers are made of PEEK*OPTIMA radiolucent material and features a large axial lumen to maximize the area for packing autogenous bone graft and enable fusion to occur through the spacer. Accompanying instrumentation streamlines the ACDF procedure. The ACIS System is intended to be used with supplemental fixation.

“The ACIS System is very comprehensive and user friendly, especially with the shorter instruments, which are easier to use under the scope. The three different spacer sizes provide a good option for all patients and all levels. The larger lumen and the ability to insert large amounts of graft material is very important for adequate fusion and stability,” said Ali Chahlavi, MD,** a neurosurgeon at St. Vincent’s Medical Center in Jacksonville, Florida.

ZERO-P VA is the newest addition to the ZERO-P family of implants, stand-alone devices that combine the functionality of a cervical interbody spacer with the benefits of an anterior cervical plate. (1-4) The new implant, which is available in three sagittal profiles, features a two-variable-angle-screw and a one-step screw securing mechanism. Another version, the ZERO-P, features a four-screw rigid locking construct. The devices come pre-assembled with a spacer made from PEEK* OPTIMA and a titanium alloy interbody plate.

Unlike traditional anterior cervical plates, ZERO-P family of implants are placed in the disc space with minimal to zero protrusion beyond the anterior surface of the vertebral body designed to minimize contact with local anatomical structures and prevent contact with adjacent levels. In addition, because of the pre-assembly of the plate and spacer, the plate is automatically aligned upon insertion of the implant.

The ACIS System and ZERO-P VA are part of DePuy Synthes Spine’s extensive portfolio of cervical fusion and arthroplasty devices and solutions including CAM-LOC Active-Locking Plate System, SKYLINE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System, VECTRA Anterior Cervical Plate System, ZERO-P Zero-Profile Anterior Cervical Interbody Fusion System, SYNAPSE OCT Spinal System, MOUNTAINEER OCT Spinal System and PRODISC -C Total Disc Replacement System.

About DePuy Synthes Spine

DePuy Synthes Spine has one of the largest and most diverse portfolios of products and services in spinal care and is a global leader in traditional and minimally invasive spine treatment. The company offers procedural solutions for the full spectrum of spinal disorders including adult and adolescent deformity, spinal stenosis, trauma and degenerative disc disease. DePuy Synthes Spine is part of DePuy Synthes Companies of Johnson & Johnson, the largest provider of orthopaedic and neurological solutions in the world. For more information visit, www.depuysynthes.com.

References

*Polyetheretherketone

** Dr. Chahlavi is a paid consultant to DePuy Synthes Spine

Kaiser MG, Haid RW Jr., Subach BR et al. (2002) Anteriorcervical plating enhances arthrodesis after discectomy andfusion with

cortical allograft. Neurosurgery. 50:229–236.

Caspar W, Geisler FH, Pitzen T et al. (1998) Anterior cervicalplate stabilization in one- and two-level degenerativedisease:

overtreatment or benefit? J.Spinal Disord. 11:1–11.

Mobbs RJ, Rao P, Chandran NK (2007) Anterior cervical discectomy and fusion: analysis of surgical outcome with and without

plating. J.Clin.Neurosci. 14:639–6342.

Moftakhar R, Trost GR (2004) Anterior cervical plates: a historical perspective. Neurosurg.Focus. 16:E8

Source : http://www.news-medical.net/news/20121024/ACIS-Anterior-Cervical-Interbody-Spacer-System-launched-by-DePuy-Synthes-Spine.aspx

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Adachi purchases Mazor Robotics’ Renaissance surgical guidance system for spine procedures

Adachi purchases Mazor Robotics’ Renaissance surgical guidance system for spine procedures

Mazor Robotics Ltd. (TASE:MZOR), a developer of innovative surgical robots and complementary products, today announced that Adachi Medical Instruments Co., Mazor’s distribution partner in Japan, placed an order for its Renaissance™ system. As part of the distribution agreement, Adachi is committed to obtain Japanese PMDA (Pharmaceuticals and Medical Devices Agency) approval for the Renaissance system. The system purchased will be used to facilitate the PMDA process

“The distribution agreement and initial purchase order from Adachi signifies an important step in expanding the market for Renaissance in Asia”

Japan represents the second largest healthcare market in the world, and its spine market is estimated to be over $400 million with a significant trend towards surgeons performing minimally invasive procedures. It is projected that by 2020, nearly 50% of Japan’s population will be over the age of 50, driving the need for improved spinal implant technology.

“We are delighted to partner with Mazor to deliver their innovative products to the Japanese market,” commented Saburo Adachi, President of Adachi. “We believe strongly in the strength of a mutually beneficial partnership and look forward to working together with Mazor to meet the requirements of the Japanese government to obtain the necessary approvals and deliver this advanced technology to Japan.”

“The distribution agreement and initial purchase order from Adachi signifies an important step in expanding the market for Renaissance in Asia,” said Ori Hadomi, Chief Executive Officer of Mazor. “Adachi is an 80 year-old family-owned business that has established relationships with leading hospitals and medical organizations. It has significant experience in distributing leading medical technology and clearing the regulatory hurdles. We’re so pleased to enter the Japanese market with Adachi as our partner.”

Renaissance, Mazor Robotics’ next generation surgical guidance system for spine procedures, is transforming spine surgery from freehand operations to highly-accurate, state-of-the-art procedures, with less radiation – even for minimally invasive surgery, scoliosis, and other complex spinal deformity cases. It is the only robotic technology for spine surgery available in the marketplace.

Source : http://www.news-medical.net/news/20121022/Adachi-purchases-Mazor-Robotics-Renaissance-surgical-guidance-system-for-spine-procedures.aspx

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