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Medtronic Neurostimulator Recall

Medtronic Neurostimulator For Bladder Problems

Medtronic Neurostimulator For Bladder Problems

I am new to this site so don't really understand how to use it yet. I have a Medtronic implanted device since 2001 and have been having serious problems for about three years. When things go wrong no one will talk and groups that do talk about it cut you off because you want action by the governing bodies that permit these devices to be implanted and used on patients. But when things go wrong there is no one to listen and no one cares. You are just left to walk around in agony and confusion and the device is still inside you and no one is monitering it or you. Has anyone complained to the FDA or others and what response have you got. you mighwant to google the interstem name and see what else you turn up.......... good luck - Laura I'm in the same boat as you! I almost can't believe how things turned out after 2 interstim implants. I have been having so many problems and my health has gotten so much worse than before the implants. I can't wear shoes most of the time because of nerve problems and a slew of other symptoms. My last visit with the doctor who implanted the devises ended with her chucking me from the office. An administrator came into the exam room and wanted to know why I no longer had Keystone Healthplan because the removals would only require a referral. But because I had only medicare now, it only pays 80%. The doctor refused to see me and now I'm left high and dry. Every other doctor I contacted won't help because there is a problem and they all say the same thing...go back to who put them in. Any advice? I'm so drained from this whole ordeal! This is a very common way for Medtronic to treat people when the device goes wrong and it usually happens after the followup surgeries to try to put things right. When they took out the old battery and put in a ne Continue reading >>

Department Of Health | Medical Device Control Office - Recalls And Alerts

Department Of Health | Medical Device Control Office - Recalls And Alerts

Medical Device Safety Alert: Medtronic spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers Medical device manufacturer, Medtronic, has issued a field safety notice concerning certain models of spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers. According to the manufacturer, there will be upcoming changes to the adverse event labeling for Medtronic spinal cord stimulation therapy. Current labeling addresses the potential for neurological complications associated with the surgical implant procedure; however, they do not address the potential for epidural mass formation and subsequent spinal cord compression. The manufacturer has identified 14 reports over the last 30 years describing delayed spinal cord compression due to an epidural mass around a Medtronic spinal cord stimulation (SCS) lead. All patients had neurological deficits and required surgical intervention to remove the mass. Histologically, the epidural masses consisted of reactive tissue (granulomatous and/or fibrous tissue). The reported time to onset of neurological symptoms after lead implant ranged from weeks to 17 years. The severity ranged from muscle weakness to progressive quadriparesis. According to the manufacturer, the number of reports corresponds to an estimated rate of occurrence of less than 1 in 10,000 patients. The reports involved various models (8 surgical leads, 6 percutaneous leads). The data indicate that this issue is not limited to specific lead models or lead location (8 cervical, 3 thoracic, and 3 unknown). The frequency of spinal cord compression due to this issue was found to be significantly higher with the use of surgical leads and significantly higher with cervical lead location, Continue reading >>

Medtronic Model 37751 Recharger - Used With Neurostimulators

Medtronic Model 37751 Recharger - Used With Neurostimulators

Australian Government Department of Health Medtronic model 37751 recharger - used with neurostimulators Recall for product correction - risk of loss of therapy due to the recharger not functioning Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is undertaking a recall for product correction of Medtronic model 37751 rechargers due to an error that causes the recharger to become unresponsive. The device may be used with or without a power supply being connected. This error only occurs when it is used to recharge without a power supply being connected. To address this issue, Medtronic Australasia is providing information to health professionals, including instructions for patients on how to prevent this problem and restore functionality to unresponsive rechargers. Medtronic model 37751 rechargers are sold in kits for certain neurostimulation systems, including deep brain stimulation (DBS) and spinal cord stimulation (SCS) devices. Neurostimulation devices are implantable, programmable medical devices that deliver electrical stimulation to specific parts of the patient's brain, spinal cord or peripheral nervous system to help treat various conditions, including chronic pain, movement disorders, epilepsy and Parkinson's disease. Medtronic model 37751 rechargers are used by DBS and SCS patients who have the following devices implanted: SCS - RestoreUltra SureScan MRI (Model 97712) SCS - RestoreAdvanved SureScan MRI (Model 97713) SCS - RestoreSensor SureScan MRI (Model 97714). It has been identified that Medtronic model 37751 rechargers may stop functioning and this loss of function is signalled by a blank display screen combined with a beep every five seconds. This occurs only when the recharger is used while disconnec Continue reading >>

Medtronic Lawsuits

Medtronic Lawsuits

Many Medtronic lawsuits have been initiated across the United States and Canada by patients who suffered grievous harm due to defective products prescribed by their doctors and manufactured by Medtronic, Inc. or one of its subsidiaries. Such lawsuits seek financial compensation for the losses suffered, which may include: Overwhelming medical bills, such as for medical treatment, hospitalization, and medication Loss of income from missed work both short- and long-term Costs of physical rehabilitation and occupational therapy/job retraining In fatal cases, the huge costs related to the loss of a loved one Medtronic is a huge company, a manufacturer of medical devices that are used in 120 countries around the world, for over 30 types of medical conditions and diseases. Medtronic lawsuits are a regular occurrence. The number of Medtronic lawsuits is large enough that several law firms in the U.S. focus solely on Medtronic lawsuits, and many more product liability attorneys also represent the injured in their lawsuits based on Medtronic device failures and defects. Some of the products that Medtronic makes are: defibrillators one model of which has been recalled due to malfunctions and failures neurostimulators e.g., for movement, pain, bladder and psychiatric disorders shunts for hydrocephalus (a condition in which too much cerebrospinal fluid builds up in the brain's ventricles) radio frequency therapy for BPH (benign prostatic hyperplasia) gastric electrical stimulation for gastroparesis (a stomach disorder) Many Medtronic lawsuits have ended in settlement. That is, Medtronic simply agrees to compensate the damages incurred by a user of their products without a judge having ordered the company to do so. In many cases, Medtronic agrees to a settlement without acknowledgin Continue reading >>

Medtronic Archives - Neuronews International

Medtronic Archives - Neuronews International

In this educational supplement we focus on ischaemic stroke. We look at the results of the ASTER trial and experts weigh in on the... Medtronic gets US FDA clearance for Riptide aspiration system The Riptide aspiration system is intended for use in the revascularisation of patients with acute ischaemic stroke secondary to intracranial large vessel occlusive disease... FDA approves new clinician programmer for SynchroMed II intrathecal drug delivery... The US Food and Drug Administration (FDA) has approved a new clinician programmer for use with the SynchroMed II Intrathecal Drug Delivery system (Medtronic),... First patient enrolled in study to assess optimised spinal cord stimulation... The first patient has been enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are... Intellis platform receives CE mark for spinal cord and peripheral nerve... Medtronic has received CE mark for the Intellis platform for both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) as an aid in... FDA approves Intellis platform for chronic pain The US Food and Drug Administration has approved the Intellis spinal cord stimulation platform (Medtronic) for the management of certain types of chronic intractable... SureTune3 earns CE mark for deep brain stimulation therapy CE mark has been granted to the SureTune3 software (Medtronic) for deep brain stimulation (DBS). SureTune3 provides patient-specific visualisation of lead location and simulated... SureTune3 deep brain stimulation software receives Health Canada licence Medtronic has received a Health Canada licence for SureTune3 software for deep brain stimulation (DBS). The latest innovations in the SureTune technology are designed... Medtronic announces volun Continue reading >>

How Spine Implants Cause More Harm Than Good

How Spine Implants Cause More Harm Than Good

How Spine Implants Cause More Harm than Good Stimulation therapy is a growing treatment intended to relieve chronic pain in the spinal cord by sending electrical pulses through an implant. In some patients, the procedure works well and pain is well-managed. In others, the operation turns dire, causing permanent paralysis. Medical device attorneys at Pintas & Mullins Law Firm look into these implants and who is to blame when a patient is paralyzed. Spinal stimulator devices are manufactured by a variety of companies, including Medtronic, Boston Scientific, and St. Jude Medical. The devices are implanted into patients near the spinal cord, where a pulse generator sends low currents of electricity into extension wires, which are placed on the spine. The leads then transmit an electrical current onto the spine that distracts the brain from recognizing and therefore feeling pain signals. Patients are typically admitted to hospitals for overnight stays, and can return home shortly after implantation with, ideally, a pain-free life. For dozens of patients, the procedure goes too far, causing partial or permanent paralysis or motor weakness. In most of these cases, the injury occurs after the spinal cord is punctured or compressed by the electrical conductors, which are inserted into a narrow cavity called the epidural space in the lower spine (this is where an epidural anesthesia is administered during childbirth). According to the FDAs database, nearly 60 patients were paralyzed by spinal stimulators in 2013 up from nearly 50 the year before. It is worth noting that the FDAs database is far from complete, and many assert that injuries are vastly underreported. Doctors highlight a potential cause of the problem insufficient awareness by doctors on the true risks of operating Continue reading >>

Parkinson's: Dbs? Read This

Parkinson's: Dbs? Read This

Lisa Vanderburg Independent Research Writer at Spotlight YOPD (Registered Charity UK) Amongst my other 'talents', I do love a good mystery to gnaw on. And this one was a doozy! I'm a wife and carer to a Parkinson's patient who underwent DBS in September of 2012. Now, that really piqued my interest: not the how (way beyond my mental prowess), but the who, what and why. I spent the next year or so researching PD and DBS via the World Wide Web (not Wiki...sorry!). Fundamentally, what I've done is collate all that information into a readable, informative and (hopefully) enjoyable read. I'm a bit pithy with it because of some of what I've learned. My papers have been checked and my sources are available for anyone who wants them. Permissions have been sought from Medical Publishing sites, although nothing is taken verbatim, just in my own words. The point of this page is to give those PDers and their families some perspective in what I know to be a very harried and difficult time. The last thing in anybody's mind is 'hang on....I want to choose who's in my head!' Lets start with a brief history. Professor Alim-Louis Benabid, of Grenoble, France, is the accredited father of todays DBS. That is to say, it was he who discovered that high-frequency pulses, introduced into the correct target of the brain, reduced Parkinsons symptoms. But wait! What about Spiegel & Wycis, who in 1947 published their paper Studies in Stereoencephalotomy. Respectively Neurologist and Neurosurgeon, they were busting nuts to get away from the appalling destruction caused by frontal lobotomies for psychiatric patients. It wasnt long before these guys caught onto motor-function disease, so que? Or Irving Cooper? Who in the 1960s, nicked the internal carotid artery of a brain surgery patient, inducing a Continue reading >>

Medical Device Recalls Since March 26, 2018

Medical Device Recalls Since March 26, 2018

Medical Device Recalls since March 26, 2018 U.S. Food and Drug Administration - Center for Devices and Radiological Health, Medical Device Class 1, 2 and 3 Recalls The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy. IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems A Continue reading >>

Medtronic Warns On Deep Brain Stimulation Charger Issue

Medtronic Warns On Deep Brain Stimulation Charger Issue

Home Medtronic warns on deep brain stimulation charger issue Medtronic warns on deep brain stimulation charger issue Medtronic (NYSE: MDT ) warnedcustomers this month of an issue withsome of its Model 37751 rechargers for its deep-brain stimulation devices, saying they may become unresponsive and unable tofully recharge the neurostimulator until they are reset. Customers have complained that some of their rechargers are nonfunctional, bleeping every 5 seconds with a blank display screen, Medtronic warned in a letter to customers. All rechargers manufactured since November 2014 are susceptible to theerror state, whichhas been reported for 2% of all rechargers manufactured since that date and 0.2% sold before that date. The recharger is used by patients who are implanted with an neurostimulator for deep brain stimulation therapy. Nonfunctional rechargers are unable to recharge the neurostimulator until the recharger is reset, Medtronic wrote in the letter. When the neurostimulator battery is fully depleted, patients can lose their therapy and symptoms may return. Some patients receiving deep brain stimulation therapy, such as people with Parkinsons disease, can experience life threatening injury and even death if they stop their stimulation therapy. The Fridley, Minn.-based company reported that it has not received notice of any life threatening injury or death associated with this problem. To preventthe problem, Medtronic recommended that the recharger be plugged into the AC power supply prior to recharging the neurostimulator and remain connected until the recharging session is complete. If the recharger is already unresponsive, the company suggested assisting patients with a reset of the recharger. While it figures out a permanent solution, Medtr Continue reading >>

Medtronic Launches Next-gen Spinal Cord Stimulator For Chronic Pain Management

Medtronic Launches Next-gen Spinal Cord Stimulator For Chronic Pain Management

Medtronic Launches Next-Gen Spinal Cord Stimulator for Chronic Pain Management Includes world's smallest implantable spinal cord stimulator; offers personalized pain relief and advanced activity tracking. Medtronic's Intellis Spinal Cord Stimulation Platform. Image courtesy of Medtronic. New 510(k) Approach Would Leverage FDA Objective Criteria Medtronic plc announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSMworkflow, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs. Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device. "Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. "This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse." Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.1Chron Continue reading >>

Texas Lawyers Blog: Defective Spinal Stimulators: Medtronic Stimulators And Boston Scientific Stimulators May Malfunction By Defective Spinal Stimulator Lawyer Jason S. Coomer

Texas Lawyers Blog: Defective Spinal Stimulators: Medtronic Stimulators And Boston Scientific Stimulators May Malfunction By Defective Spinal Stimulator Lawyer Jason S. Coomer

Removal of Defective Spinal Stimulators May Be The Basis for a Lawsuit In most cases, when a stimulator is found to be defective it must be removed. This surgery can be both costly and cause its own complications. Not only is there always a risk of infection with every surgery, but because the removal of a stimulator requires navigating delicate nerves in the spine, it is possible that nerves can be nicked or otherwise damages during the procedure leading to symptoms such as weakness, pain, or numbness in the body. In some cases, removal of the simulator can result in a leakage of spinal fluid from the epidural space, leading to severe and long-lasting headaches or feelings of fatigue which may heal on its own or may require its own surgery to repair. Implantable Spinal-Devices Are a Multi-billion Dollar Industry and Two of Leading Manufacturers In the Industry Are Medtronic and Boston Scientific Implantable Neurostimulation Systems and other spinal-devices are a huge business for the medical implant device industry. The global market for spinal-devices is currently over $ 3 billion per year and is expected to increase to over $5 billion per year by 2018. Neurostimulators have been used for a variety of types of chronic back pain situations including heriniated disks, postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk surgery, Degenerative Disk Disease, and Failed Back Syndrome. The Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbsincluding unilateral or bilateral pain associated with several different conditions. Unfortunately, because of the profits to be made from implanting a spinal stimulator, many people have received sp Continue reading >>

Medtronic Settles $2.8 Million Off-label Suit Over Neurostimulator Promotion - Policy And Medicine

Medtronic Settles $2.8 Million Off-label Suit Over Neurostimulator Promotion - Policy And Medicine

Medtronic Settles $2.8 Million Off-Label Suit Over Neurostimulator Promotion Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company promoted its neurostimulator device for unapproved chronic pain treatment. According to the complaint, originally filed by former Medtronic sales rep Jason Nickell, Medtronic sales staff were directed to sell the device at discounted prices to pain management doctors. Nickell also alleged that sales reps promised physicians could make upward of $10,000 profit on each patient, while adding only minutes to the procedure" by using a billing code meant for an FDA-approved use. Neurostimulation provides pain relief byblocking pain messages before they reach the braininstead of pain, patients feel a tingling sensation. According to the complaint, the procedure and intended use of neurostimulation devices at issue, referred to as Sub-Q, subcutaneous targeted neurostimulation (STN), or peripheral nerve field stimulation (PNFS), was a new application of an older device first developed around 2005 and still in an experimental stage as Medtronic was promoting it. The complaint was initially filed by Jason Nickell, a former Medtronic sales rep who, as a Medtronic employee, made $600,000 per year selling the neurostimulation devices. The U.S. later joined in. According to Nickell, he quit his job over concerns about the promotional practices and then filed a lawsuit under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the governments recovery. Nickell will receive $602,000apparently just $2,000 above his yearly salary while selling Medtronic devices. Nickell alleged tha Continue reading >>

Failed Back Surgery & Implant Neurostimulator Lawsuit Lawyer

Failed Back Surgery & Implant Neurostimulator Lawsuit Lawyer

Neurostimulator Medical Malpractice Lawsuits, Neurostimulation Product Liability Lawsuits, Implantable Neurostimulation Systems, and Failed Back Surgery Resulting in Permanent Disability and Paralysis Lawsuits by Texas Failed Back Surgery Product Liability, Medical Negligence, & Defective Product Lawyer, Jason Coomer Failed back surgery including defective implantable neurostimulation systems can cause catastrophic injuries and impairment. These failed back surgery cases can be caused by defective spinal-devices or medical negligence, and can take significant resources to investigate and file a lawsuit. When investigating these potential failed back surgery lawsuits it is important to know what implant was used as well as to obtain medical records of the surgery. If you or a family member have been the victim of a failed spinal cord surgery including a defective neurostimulation implant, please feel free to submit an inquiry or send an e-mail to Texas final spinal cord surgery and defective implantable neurostimulation lawyer Jason Coomer. He is a Texas defective product lawyer & medical negligence lawyer and commonly works with other product liability and medical negligence lawyers to investigate and handle medical negligence/product liability lawsuits. Implantable Neurostimulation System Lawsuits and Failed Spinal Cord, Neck, & Back Surgery Lawsuits Implantable Neurostimulation Systems have been used for a variety of types of chronic back pain situations including heriniated disks, postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk surgery, Degenerative Disk Disease, and Failed Back Syndrome. In fact, implantable neurostimulation systems and other spinal-devices are a huge business for the medical implant device industry including Medtronic, a lead Continue reading >>

Device Complications News Feed

Device Complications News Feed

News Briefs about Device Complications from the International Neuromodulation Society Warning Letter Issued About Deep Brain Stimulation Recharger Issue Oct. 19, 2016 - Medtronic has warned customers this month that some rechargers for deep brain stimulation devices "may become unresponsive and unable to fully recharge the neurostimulator until they are reset," Mass Device reported, adding, "To prevent the problem, Medtronic recommended that the recharger be plugged into the AC power supply prior to recharging the neurostimulator and remain connected until the recharging session is complete. If the recharger is already unresponsive, the company suggested assisting patients with a reset of the recharger." (Mass Device) Hazard Alert Issued in Australia for Some Neurostimulation Devices Regarding Potential Loss of Stimulation, Over-Stimulation or Stimulation in the Wrong Area Feb. 4, 2014 - In consultation with the Australian Department of Health's Therapeutic Goods Administraton, Medtronic Australasia has issued a hazard alert and recall for product correction concerning deep brain stimulation (DBS) and spinal cord stimulation (SCS) models that may pose a potential for loss of stimulation or over-stimulation or stimulation in the wrong area under certain conditions: DBS models Activa PC, Activa RC and Activa SC models 37601, 37602, 37603, 37612 (Activa SC models 37602 and 37603 are not affected by the over-stimulation or stimulation in the wrong area issue); and SCS RestoreUltra and RestoreSensor models 37712, 37714. Avoiding over-discharge is advised for reducing the likelihood of over-stimulation or stimulation in the wrong area -- patients should call 1800 688 670 if their device is over-discharged. At the next visit a software upgrade to the clinician's programmer wi Continue reading >>

Spinal Cord Stimulators Paralysis, Adverse Effects

Spinal Cord Stimulators Paralysis, Adverse Effects

Pain Management Specialist in San Diego & La Jolla In April 2014, the Wall Street Journal published an analysis of adverse events associated with spinal cord stimulators: When Spine Implants Cause Paralysis, Who Is to Blame? These events were submitted to the FDA or were obtained from medical malpractice law suits. In many cases, the injuries occurred after patients spinal cords were punctured or compressed by the stimulator electrodes.The FDAs database contains 58 unique reports of paralysis with report or event dates from 2013, compared with 48 in the prior year. The spinal cord stimulators were made by various companies. Researchers at Duke University medical center recently found that nearly one in every 100 spinal stimulator patients experienced some degree of spinal cord or spinal nerve root damage, said Shivanand P. Lad, a Duke Neurosurgeon and the studys lead researcher. The study, based on insurance claim records of 12,300 stimulator patients has been submitted for presentation at an upcoming medical meeting. A 2011 study based on adverse event reports submitted by device makers found the rate of paralysis or motor weakness in patients implanted with a commonly used type of stimulator was considerably lower, at around 3.8 per 1000, with about 60% of patients eventually experiencing complete or partial recovery. Medtronic updated its product label in February to note that scar tissue can form around device electrodes and cause nerve damage, including progressive quadriparesis, or gradual weakening of all four limbs. Medtronic estimates that as many as 50,000 people in the U.S. are implanted with spinal stimulators each year from all device makers. Stimulators cost between $20,000 and $60,000 each and have estimated global sales of $1.5 billion annually. The FDA Continue reading >>

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