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Medtronic Spine Products

Medtronic And Spine Products

Medtronic And Spine Products

Medtronic makes a variety of implants for the spine. These include: The Prestige Cervical Disc - This stainless steel artificial disc is inserted in place of a diseased or bulging disc in the neck and allows the area to be moveable and flexible. It is used as an alternative to spinal fusion, which can result in loss of motion and flexibility. The CD Horizon Legacy Spinal System - This device is a series of rods, hooks, and screws implanted during spinal surgery, to correct scoliosis or abnormal side-to-side curvature of the spine. - It is made of titanium or implantable-grade stainless steel. Infuse Bone Graft and LT Cage Device. This replaces the need to take bone from the hip to use in reconstruction of an area of the spine. The device consists of two parts. One is a bone graft substitute, a protein (recombinant human bone morphogenetic protein-2) that everyone already has in their bodies. The protein regulates bone growth and healing. The other is a type of framework which the new bone grows into. Kyphon Balloon Kyphoplasty. This is a minimally invasive procedure used to treat kyphosis, a curvature of the spine that makes a person hunch over. It helps to prevent future spinal fractures. X-Stop Spacer. This is a device implanted using minimally invasive surgery. It is used to treat patients with lumbar spinal stenosis, or a narrowing of the spinal canal. Medtronic's second largest business is their Spinal and Biologics Business. It accounted for $3.0 billion (22 percent) of the company's $13.5 billion in revenue in fiscal year 2008. The manufacturing firm collaborates with medical and research personnel worldwide. Among the treatments they offer treatment are: Minimal Access Spine Technologies (MAST) to treat spine pain Fusion systems to correct spinal curvatures and Continue reading >>

6. Medtronic Sofamor Danek

6. Medtronic Sofamor Danek

Stephen H. Mahle, Exec. VP, Healthcare Policy and Regulatory Susan Alpert, Sr. VP and Chief Regulatory Officer Steve La Neve, Sr. VP and President, Spinal and Biologics That is the theme Medtronic Inc. used in its 2008 annual report, and it was an appropriate one, given the steps the company took in the last fiscal year to help shape the future of healthcare. Recognizing that many of its markets were changing, Medtronic funneled more of its fiscal 2008 resources into areas that foster innovation and growth. For years, Medtronic has been the leader of the medical technology sector, William A. Hawkins, Medtronic president and CEO, reminded shareholders in a letter published within the report. Now, we are becoming more. As we enter a new era of healthcare, we are helping to shape what quality healthcare means for patients. We are more than a provider of medical devices that save and improve lives. We are [a] leader in understanding the role medical technology plays in diagnosing, treating, monitoring and preventing chronic diseasesThe solutions to many healthcare problems will only be resolved when the public and private sectors work together to address issues such as patient access, quality and cost. Medtronic will continue to expand our leadership and meet these challenges head on. The company was true to its word in fiscal 2008. It invested more than $1.2 billion, or about 10 percent of its total revenue, in research and development. Medtronic also formed a new group called Strategy and Innovation, which combined the companys Corporate Strategy, Business Development, Ventures, and Science and Technology functions. The new group is responsible for identifying R&D opportunities that extend beyond what individual business units would develop on their own. Medtronic expand Continue reading >>

Medical Journal Blasts Medtronic-sponsored Studies Of Spine Product

Medical Journal Blasts Medtronic-sponsored Studies Of Spine Product

Medical journal blasts Medtronic-sponsored studies of spine product Medtronic and some researchers who evaluated company spine products are getting blasted in a medical journal for allegedly biased research that didn't acknowledge serious side effects. The Spine Journal found the risk to patients from Medtronic's bone graft products was as much as 50 times greater than the original company-supported research suggested. Dr. Eugene Carragee is a professor of orthopedic surgery at Stanford University and one of the doctors who reviewed 13 professional journal reports about Medtronic's spinal bone graft products. The review led to a scathing editorial published this month in The Spine Journal. Carragee said the Medtronic-sponsored studies were largely silent on important complications that subsequent, independent studies reported. "The upshot is that most doctors were unaware of the extent of complications in these trials, based on the medical literature," Carragee said. The initially unreported complications can be very serious, Carragee said. "The risks of the product included significant back pain, significant leg pain events, neurological injury, sterility in men, an association with cancer, association with the bones dissolving where the drug had come in contact," he said. "These were serious complications to have patients and doctors understand." At least some of the Medtronic-sponsored studies were flawed or structured to make Medtronic products look good, Carragee said. In addition, Carragee said Medtronic paid as much as $26 million to researchers whose studies did not report complications. Medtronic officials declined to be recorded for broadcast, but released a statement in which CEO Omar Ishrak acknowledged the Spine Journal's questions about researchers' concl Continue reading >>

Mazor Robotics Signs Strategic Commercial And Investment Agreements With Medtronic, A Global Leader In Spine Technologies And Solutions

Mazor Robotics Signs Strategic Commercial And Investment Agreements With Medtronic, A Global Leader In Spine Technologies And Solutions

MAZOR ROBOTICS SIGNS STRATEGIC COMMERCIAL AND INVESTMENT AGREEMENTS WITH MEDTRONIC, A GLOBAL LEADER IN SPINE TECHNOLOGIES AND SOLUTIONS CAESAREA, Israel May 18, 2016 Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a leading developer of innovative bone mounted surgical robotic guidance systems, today entered into two strategic agreements with Medtronic plc (NYSE: MDT). One agreement is a two-stage, multi-faceted, commercial agreement for co-promotion, co-development and, upon meeting certain milestones, potential global distribution of certain Mazor products. The second agreement is for an equity investment by Medtronic in Mazor. The commercial agreement has an initial U.S.-based co-promotion phase. If both organizations achieve their respective milestones by the end of 2017, then the companies will enter the second phase of the agreement, in which Medtronic will assume exclusive global sales and distribution rights for Mazors future spine products. The second phase includes annual quotas with a cumulative potential of hundreds of next-generation systems over a four-year period. The commercial agreement is for Mazors future systems and applications, and Medtronic has placed a commitment to purchase 15 of these future systems during 2016. The agreement also stipulates Mazor will be Medtronics sole strategic partner for development and commercialization of robotic-based spine systems and applications. The two companies have already begun co-development activities of synergistic products and applications for spine, and will begin working closely together to meet designated sales targets through a defined methodology for cooperation. The structure of the commercial agreement features some very important points for our customers as well as our shareholders, said Ori Hadom Continue reading >>

Medtronics Infuse Can Make Men Sterile, Study Says - The New York Times

Medtronics Infuse Can Make Men Sterile, Study Says - The New York Times

Business Day |New Study Links Spine Product From Medtronic to Risk of Sterility in Men A surgeon at Stanford University , in a study released Wednesday, suggests that one of Medtronic s best-selling spinal products poses a risk of male sterility. That finding is in stark contrast to earlier research by doctors paid by Medtronic, who found no connection between the product, Infuse, and a condition that causes sterility. Infuse is a bioengineered bone growth protein that has been widely used in spinal fusion procedures since 2002. The Infuse label notes the sterility-related complication as a possible side effect, but the Medtronic-sponsored researchers in published reports attributed that complication to surgical technique, not the product itself. The Stanford surgeon, Dr. Eugene J. Carragee, found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft , another material that is used to fuse spinal vertebrae. He urged doctors to counsel men about Infuses risks. The study was posted Wednesday on the Web site of The Spine Journal , which he edits. It is important that men who are considering having children have the opportunity to weigh the risks of the various available procedures, said Dr. Carragee, who based his study on 240 patients he treated several years ago with Infuse or a bone graft. The type of spinal fusion at issue is known as an anterior lumbar fusion, a procedure performed on about 80,000 patients a year in this country. Infuse is used in about half of those procedures, and men make up about half of the patients who undergo spinal fusions. The sterility complication at issue in Dr. Carragees study affects only men, not women. Among the 69 patients treated by Dr. Continue reading >>

Medtronics Spine Business Dynamics Amid A Challenging Market

Medtronics Spine Business Dynamics Amid A Challenging Market

MDT) RTG (Restorative Therapies Group) business registered YoY (year-over-year) sales growth of ~2.0%, which came in below expectations due to the negative impact of Hurricane Maria. For an overview of the impact of Hurricane Maria, please read Divestiture and Natural Disasters Hurt MDTs Sales Performance Medtronics Spine segment, which is reported under the companys RTG business, reported a decline of ~1.0% in sales in fiscal 2Q18. The segments Core Spine sales registered a low single-digit decline, whereas its BMP (Bone Morphogenetic Protein) sales also registered growth. In fiscal 2Q18, the weakness in Medtronics spine sales was mainly driven by the negative impact of Hurricane Maria. However, when adjusted for the hurricane impact, Medtronics core spine business performed better than that of the global spine market, which continues to witness deceleration. The company believes that its speed-to-scale product launch initiative and surgical synergy strategy are the key growth drivers of its core spine business. Medtronic entered into a partnership with Mazor Robotics in 2016. This partnership entailed the development, promotion, and distribution of some of the spine products of Mazor Robotics. For details of the deal, please read Medtronic: The New Entrant into the Robotic Surgery Business Mazor Robotics is set to deliver integrated procedures with Medtronics spine implants, which could help expand Medtronics footprint in the spine market. However, Intuitive Surgical dominates the robotic surgery market in the United States. Medtronic and Verb Surgical (a joint venture of Google (GOOG) and Johnson & Johnson ( JNJ)) are the new players in the US robotics market and are expected to provide stiff competition to Intuitive Surgical. Medtronic noted that these factors help Continue reading >>

Medtronic

Medtronic

Medtronic Public Limited Company is a medical device company. Its headquarters are in Dublin, Ireland.[1][3][4][5] Its operational headquarters are in Fridley, Minnesota.[1][6] Medtronic is among the world's largest medical equipment development companies.[7] In 2015, at the time of its acquisition of Covidien, its market capitalisation was about $100 billion.[8] Medtronic operates in more than 140 countries.[1] It employs over 85,000 people and has more than 53,000 patents.[9] History[edit] Early history[edit] Medtronic Operational Headquarters in Fridley, Minnesota, a suburb of Minneapolis. Medtronic was founded in 1949 in northeastern Minneapolis by Earl Bakken and his brother-in-law, Palmer Hermundslie, as a medical equipment repair shop.[10] Through his repair business, Bakken came to know C. Walton Lillehei, a doctor of heart surgery at the University of Minnesota Medical School. The deficiencies of the pacemakers of the day were made painfully obvious following a power outage over Halloween in 1957, which affected large sections of Minnesota and western Wisconsin.[11] A pacemaker-dependent paediatric patient of Lillehei died because of the blackout. The next day, Lillehei spoke with Bakken about developing some form of battery-powered pacemaker. Bakken modified a design for a transistorised metronome and created the first battery-powered external artificial pacemaker. Medtronic's old headquarters in St. Anthony, Minnesota The company expanded through the 1950s, mostly selling equipment built by other companies but also developing some custom-made devices. Bakken built a small pacemaker that could be strapped to the body and powered by batteries. Work in the new field later produced an implantable pacemaker in 1960. The company built headquarters in the Minneapoli Continue reading >>

6. Medtronic Spine - Covering The Specialized Field Of Orthopedic Product Development And Manufacturing

6. Medtronic Spine - Covering The Specialized Field Of Orthopedic Product Development And Manufacturing

Gary Ellis, Exec. VP & Chief Financial Officer, Medtronic Mike Genau, Sr. VP & President, Americas Region, Medtronic Richard E. Kuntz, M.D., Sr. VP & Chief Scientific, Clinical and Regulatory Officer, Medtronic Chris Lee, Sr. VP & President, Greater China Region, Medtronic Stephen N. Oesterle, M.D., Sr. VP, Medicine & Technology, Medtronic Luann Pendy, Sr. VP, Global Quality, Medtronic Rob Ten Hoedt, Exec. VP & President, Europe, Middle East and Africa Region, Medtronic Bob White, Sr. VP & President, Asia Pacific Region, Medtronic Geoff Martha, Exec. VP & President, Medtronic Restorative Therapies Group Without a doubt, Medtronic is a company of firsts. Most of its milestones, of course, are breakthroughs in healthcare technologythe first battery-operated external pacemaker (1957); the first commercially produced implantable pacemaker (1960); the first implantable, programmable neurostimulation device for chronic pain (1983); the first implantable cardioverter defibrillator (1993); the first insulin pump with real-time glucose monitoring (2006); and there are many other examples, in innovation as well as in the companys far-reaching philanthropic work. But 2014 saw anotherand perhaps less auspicious, depending upon your point of viewfirst for the worlds largest standalone medical device company. With its nearly $50 billion purchase of Dublin, Ireland-based Covidien plc, Medtronic pulled off the largest-ever inversion deal (at the time) in U.S. history. Medtronic Inc., once headquartered just outside Minneapolis in Fridley, Minn., became Medtronic plc, now rooted in its acquisitions base in Dublin. Inversion deals are structured to reduce U.S. income taxes and typically involve a U.S.-based company acquiring a foreign firm and relocating there for tax purposes. The deal Continue reading >>

Contact Us - Healthcare Providers | Infuse Bone Graft

Contact Us - Healthcare Providers | Infuse Bone Graft

At Medtronic , we're committed to Innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease. To do that, we're thinking beyond products and beyond the status quo - to continually find more ways to help people live better, longer. Medtronic has a variety of support teams available for HCP Providers and Hospital Administrators who are responsible for making product decisions for their hospital or facility. For help with orders, tracking shipments and locating your local sales representative. 800.933.2635 For product technical questions contact the Biologics Marketing Department: 800.876.3133 For general questions about reimbursement, support for authorizations, coding assistance and coverage bringing day-to-day business and reimbursement systems into focus so that medical professionals are free to concentrate on clinical issues and patient care. General questions about spine reimbursement for sales, surgeon or hospital Support for authorizations and denials involving Medtronic products Coding assistance for hospitals and physicians Advocacy and information on coverage and other issues with commercial payers Web based courses on coding, documentation and other practice or hospital reimbursement information Continue reading >>

Studies Fail To Back Medtronic Spine Product

Studies Fail To Back Medtronic Spine Product

Studies Fail to Back Medtronic Spine Product Two independent studies found a controversial Medtronic Inc. bone-growth product for spine surgeries was no better than a traditional operation. The studies were the result of a two-year experiment in lifting the veil on industry-sponsored trial data. Medtronic's product, called Infuse, has been plagued by allegations that doctors who wrote key studies backing the technology received millions of dollars in royalties and fees related to other work and may have understated risks. Copyright 2018 Dow Jones & Company , Inc. All Rights Reserved.

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  • Medtronic $$$ Buy Reports That Slam Spine Product

    Medtronic $$$ Buy Reports That Slam Spine Product

    Medtronic $$$ Buy Reports That Slam Spine Product by John Fauber John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today Two independent reports published Monday in Annals of Internal Medicine found that Medtronic's spine surgery product known as Infuse offered little benefit over conventional spine surgery and may be linked to serious harms including cancer and a complication that causes sterility in men. The twist: This time the critical reviews were funded by Medtronic itself. In 2011, the company agreed to allow Yale University to oversee the studies in the wake of concerns found by other independent researchers, a U.S. Senate Committee on Finance investigation, and investigative reports in the Milwaukee Journal Sentinel and MedPage Today dating to 2009. "Spine surgeons are really going to have to be careful with using (Infuse)," said Dan Spengler, MD, a professor of orthopedic surgery at Vanderbilt University Medical Center who was not a part of the reviews. "There is going to be a liability storm." The reports amount to yet another rebuke of the biological agent, which stimulates bone growth and has been implanted in the spines of more than one million people, most of whom got it in unapproved ways. Infuse, known scientifically as bone morphogenetic protein-2, or BMP-2, once produced sales of nearly $1 billion a year, revenue that has withered to $528 million in fiscal 2013 in the wake of negative accounts about its safety and effectiveness. At the heart of the controversy has been a small group of spine surgeons who got $210 million in royalties from Medtronic over the years while co-authoring papers that failed to link the product to serious complications. One report was from researchers at Oregon Health & Science University, the other from University o Continue reading >>

    Medtronic Spine Division Shows Growth In Fourth Quarter 2017 - Memphis Business Journal

    Medtronic Spine Division Shows Growth In Fourth Quarter 2017 - Memphis Business Journal

    Digital Producer, Memphis Business Journal After seeing its strongest performance in seven years, the Memphis division of an Ireland-based medical technology company continue to grow. Medtronic announced financial results May 25 for the fourth quarter and the 2017 fiscal year, which ended April 28. The company reported fourth quarter worldwide revenue of $7.9 billion, compared to $7.5 billion in the fourth quarter of fiscal year 2016, an increase of 5 percent. Fourth quarter U.S. revenue was $4.4 billion and represented 56 percent of the company's overall revenue. Net income for the quarter was $1.836 billion, with diluted earnings per share of $1.33. Medtronic's Restorative Therapies Group (RTG), which includes the Brain Therapies, Specialty Therapies and Pain Therapies divisions, as well as the Memphis-based Spine division, grew 5 percent. The Memphis-based Spine division's revenue of $676 million was an increase of 3 percent. Medtronic Spine delivered another strong quarter of growth for the fourth quarter, Doug King , senior vice president and president of Medtronic Spine, said in a statement. Our new product pipeline has had great response from customers. We continue to differentiate by launching complete procedural solutions at a large enough scale to impact the market. In addition, our Surgical Synergy program is gaining traction through bundling, enabling technologies like navigation systems with our implants and instruments to improve outcomes. During the earnings conference call, chairman and CEO of Medtronic Omar Ishrak said the company made progress in each of its growth strategies. "We delivered record revenue of $29.7 billion, growing approximately 5 percent, in the mid-single digits for the fifth consecutive year," Ishrak said. "But most importantly in f Continue reading >>

    Medtronic Spine Is Still Hobbled Over

    Medtronic Spine Is Still Hobbled Over

    Despite solid overall results, Medtronic reported that its spine business declined last quarter, news that is not surprising given how the business has faltered for years. Despite solid overall results, Medtronic reported that its spine business declined last quarter, news that is not surprising given how the business has faltered for years. Medtronic reported its fiscal third quarter financial results on Tuesday where it reported slightly lower-than-expected revenue, most likely because of currency fluctuations. Most analysts described the results as solid, but one analyst's question to Medtronic's CEO, Omar Ishrak, underscored the nagging under performance of the Irish company's spine division. In the quarter ended Jan.29, the spine business saw revenue decline 2% to$704 million compared with the same quarter a year ago. Although the company's bone graft product - Infuse - saw sales jump in the U.S., revenue declines were seen in Infuse sales in Europe because of a product hold. Further, the spine business was hurt becauseof decline in its core spine business that comprises rods and screws. Get ready for Massachusetts Medtech Week and register for BIOMEDevice Boston , April 13-14 to stay on top of industry trends The Spine business has been struggling for years. Infuse used to be a blockbuster product until it was revealed that some off-label use resulted in severe injury and even deaths. Newspaper articles also questioned whether doctors who were compensated by Medtronic inflated Infuse's benefits while underreporting its negatives. Although a Yale review vindicated the data Medtronic used to gain FDA approval of the product, sales have lost its luster. Additionally, under its previous CEO Bill Hawkins, Medtronic made an expensive near $4 billion acquisition of Kyph Continue reading >>

    Mazor Picks Up $20m From Medtronic As It Launches Spine Surgery Robot

    Mazor Picks Up $20m From Medtronic As It Launches Spine Surgery Robot

    Mazor picks up $20M from Medtronic as it launches spine surgery robot Earlier this year Mazor Robotics made two deals with Medtronic worth up to $50 million to come in three potential tranches. At the time, it picked up $11.9 million in return for 4% of its shares. Now, with the launch of its new robotic-assisted spine surgery system, the Israeli small cap is meeting a milestone and stands to collect a second tranche of up to $20 million from Medtronic. The initial partnership was forged in May and comprised co-promotion, co-development and the potential global distribution of Mazors future spine products by Medtronic ($MDT). All told, the tie-up could exceed $50 million, with Medtronic owning about 15% of Mazor if all tranches are executed. The third tranche depends on the initiation of global distribution of Mazors products. Mazor revealed its Mazor X guidance platform for spine surgeries on Tuesday. The system was designed to go beyond trajectory guidance and incorporate analytical tools, multisource data, optical tracking, intra-op verification and connectivity technologies, Mazor said in a statement. Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. The Mazor X platform expands the field of spine surgery from trajectory guidance to assisting surgeons with a total patient treatment strategy, said Mazor CEO Ori Hadomi in the statement." Following our recently formed partnership with Medtronic and the increased market access it provides us, the launch of the Mazor X positions Continue reading >>

    Analysis-medtronic Faces Struggle To Mend Spine Business

    Analysis-medtronic Faces Struggle To Mend Spine Business

    ANALYSIS-Medtronic faces struggle to mend spine business * Decline in spine procedures threatens turnaround plans * Back surgery under scrutiny from insurers, government CHICAGO (Reuters) - Medtronic Inc is facingan uphill battle to revive its struggling spine devicebusiness, with insurers taking a harder look at whether surgeryis the best way to treat lower back pain and fewer patientsundergoing elective procedures in the weak economy. Analysts are raising new concerns about deterioratingdemand for spinal fusion and other back surgeries just asMedtronic, the biggest maker of the devices, is completing athree-year overhaul of its business with a new product lineupthat aims to deliver growth on par with the industry. "There are two issues for Medtronic going forward. One isthe challenge of stemming their share loss and catching up tomarket growth. And second, the market itself is slowing," saidBernstein Research analyst Derrick Sung. The spine unit, with $3.5 billion in annual sales, issecond only to Medtronic's industry-leading heart rhythm devicefranchise of pacemakers and implantable defibrillators. In recent years, the spine business stumbled as a raft ofsmaller rivals with lower-priced offerings proliferated in thefusion market. Medtronic also had trouble integrating Kyphon --maker of the kyphoplasty treatment for fractures of thevertebrae caused by osteoporosis -- which it acquired in 2007. More setbacks ensued, including a pair of studies that castdoubt on the benefit of vertebroplasty, a procedure similar tokyphoplasty, and a Department of Justice crackdown on hospitalsaccused of overbilling Medicare for kyphoplasty operations. A warning from the U.S. Food and Drug Administration and aseparate DOJ probe hurt Medtronic's biological bone growthstimulation product Continue reading >>

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