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Fda Issues Stern Warning On Medtronic Devices

Fda Issues Stern Warning On Medtronic Devices

FDA issues stern warning on Medtronic devices FILE - In this Aug. 16, 2005 file photo, The "Rising Man" symbol stands in front of the Fridley, Minn., based Medtronic. Medtronic announced Friday, Nov. 15, 2013, that the Food and Drug Administration recall of 15,000 guidewires had been classified as Class I, a category reserved for products with reasonable potential to cause serious injury or death. (AP Photo/Jim Mone) FILE - In this Aug. 16, 2005 file photo, The "Rising Man" symbol stands in front of the Fridley, Minn., based Medtronic. Medtronic announced Friday, Nov. 15, 2013, that the Food and Drug Administration recall of 15,000 guidewires had been classified as Class I, a category reserved for products with reasonable potential to cause serious injury or death. (AP Photo/Jim Mone) (The Associated Press) Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries. A recall of the guidewires began Oct. 21 after Medtronic received reports of four complaints, including one patient who went into cardiac arrest but was resuscitated, company spokesman Joseph McGrath said Saturday. The recall notice warned hospitals and distributors worldwide that coating on the guidewires could break off, which could raise the possibility of blocking a blood vessel. The wires are coated to make them slide through blood vessels more easily. Medtronic announced Friday night that the Food and Drug Administration had classified the recall as Class I, a category reserved for products with reasonable potential to cause ser Continue reading >>

Medtronic To Be Based In Ireland, But Says 1,000 Minnesota Jobs Will Be Added

Medtronic To Be Based In Ireland, But Says 1,000 Minnesota Jobs Will Be Added

Medtronic to be based in Ireland, but says 1,000 Minnesota jobs will be added Business Martin Moylan St. Paul, Minn. From a legal and tax standpoint, Minnesota is losing an iconic business success story. Medtronic, which started in a Minneapolis garage, has struck a $43 billion deal to buy an Ireland-based health care company. The combined firms will be headquartered in Ireland. But that move across the Atlantic frees up billions of dollars the company will now invest in the United States. The Daily Circuit: Analysis of the deal Medtronic officials say the combination with Covidien was driven by the strategic fit between the two companies. Combined, the two firms will be able to offer hospitals and other customers everything from pacemakers and insulin pumps to brain scanners and surgical staples. The company would be number one or two in six of 10 top hospital product lines. "The strategic element of this deal is extremely important and that was the primary driver," Medtronic CEO Omar Ishrak said. "How these two companies fit, not only scale but also in terms of future introduction of future therapies." Assuming the deal wins various approvals, the combined company would have its executive offices in Dublin. But company officials say their "operational headquarters" would be in the Twin Cities, where Medtronic employs more than 8,000 people. Medtronic officials say the company plans to add 1,000 jobs in Minnesota in the next five years or so. Joanne Wuensch, an analyst for BMO Capital Markets, said the deal is a no-brainier from a product standpoint and may give the combined firm more leverage in negotiating prices with hospitals and other customers. "What these companies have been pushing for more and more is to provide a full product portfolio into the hospital," sh Continue reading >>

History | Medtronic

History | Medtronic

Today, we are the world's largest medical technology company, but we come from humble beginnings. Medtronic was founded in 1949 as a medical equipment repair shop by Earl Bakken and his brother-in-law, Palmer Hermundslie. Did these two men set out to change medical technology and the lives of millions of people? No. But they did have a deep moral purpose and an inner drive to use their scientific knowledge and entrepreneurial skills to help others. That spirit combined with our founders' personal integrity and passion became our guiding philosophy and, ultimately, the Medtronic Mission . Our first life-changing therapy a wearable, battery-powered cardiac pacemaker was the foundation for many more Medtronic therapies that use our electrical stimulation expertise to improve the lives of millions of people. Over the years, we developed additional core technologies, including implantable mechanical devices, drug and biologic delivery devices, and powered and advanced energy surgical instruments. Today, our technologies are used to treat nearly 40 medical conditions. Continue reading >>

Medtronic's Freezor Xtra Catheter Gains Fda Nod For Avnrt

Medtronic's Freezor Xtra Catheter Gains Fda Nod For Avnrt

Medtronic's Freezor Xtra Catheter Gains FDA Nod for AVNRT Medical device major Medtronic plc MDT recently announced the receipt of U.S. FDA approval for its Freezor Xtra Cryoablation Catheter to treat patients with atrioventricular nodal re-entrant tachycardia (AVNRT). The Freezor Xtra Catheter is a flexible, single-use instrument used to freeze cardiac tissue and obstruct unnecessary electrical signals within the heart. The new catheter has been developed under the AF Solutions business which is part of the Cardiac and Vascular Group at Medtronic. Notably, AVNRT is a type of abnormal fast heart rhythm which occurs most commonly in women rather than men. The main symptom of the disease is palpitations. Frequent attacks may require radiofrequency ablation, in which the abnormally conducting tissue in the heart is destroyed. The expanded indication for Medtronics latest catheter is supported by data from the Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia (ICY-AVNRT) clinical study. The results established safety and effectiveness of the Freezor Xtra Catheter for the treatment of patients with AVNRT. With 397 enrolled patients in 34 clinical trial sites across the U.S. and Canada, the study showed recovery from AVNRT was 92.6% at six months post-procedure. Medtronic PLC Price | Medtronic PLC Quote Reportedly, more than 49,000 people are diagnosed with this critical heart ailment every year. It is claimed that the expanded indication for this catheter will offer a safe and efficient therapy to patients with AVNRT. As per a recent Zion Market Research report, the globalcardiovascular monitoring and diagnostic devices marketwas valued at around $1.70 billion in 2015 and is expected to reach almost $2.60 billion by 2021, at a CAGR of around 7.0%. T Continue reading >>

Medtronic Shares Soar As Disasters Fail To Dent Guidance

Medtronic Shares Soar As Disasters Fail To Dent Guidance

Medtronic shares soar as disasters fail to dent guidance Medical technology firm maintains outlook following natural and man-made disasters Medtronic chief executive Omar Ishrak described events including a computer outage, followed by Hurricane Maria and wildfires in California, as remarkable. Photograph: Brendan McDermid/Reuters Medtronic posted its biggest intraday gain in more than four years after maintaining its outlook following a host of natural and man-made disasters in the past six months. The worlds biggest medical technology company, which is based in Ireland and run from Minneapolis, has put those struggles behind it, chief executive Omar Ishrak said. He described the events including a computer outage, followed by Hurricane Maria and wildfires in California as remarkable. The shares soared 5 per cent to $82.86 in New York, after rising 6.6 per cent earlier. Medtronic reported quarterly earnings that topped analysts estimates, and left unchanged its forecast of revenue growth of 4 to 5 per cent for the fiscal year ending in April. The company also reiterated that it expects earnings excluding certain items to rise 9 to 10 per cent from $4.37 a share a year earlier. The guidance is aggressive, implying a second-half growth rate nearly double the first six months of the year, Michael Weinstein, an analyst at JPMorgan Chase, said in a note to clients. Bloomberg Continue reading >>

Medtronics Purchase Of Covidien Raises Questions About Jobs In Mansfield

Medtronics Purchase Of Covidien Raises Questions About Jobs In Mansfield

Medtronics purchase of Covidien raises questions about jobs in Mansfield Covidien's Building 4 in Mansfield, where the company has its headquarters. (Sun Chronicle file photo by Keith Nordstrom) Medtronics Rising Man symbol stands in front of the headquarters in Fridley, Minn. (Associated Press photo) MANSFIELD Minneapolis-based Medtronic has agreed to purchase Covidien, one of the areas largest employers, for cash and stock totaling about $42.9 billion, the two companies announced. The deal, announced Sunday, could have an impact on Covidiens Mansfield-based operations as the two companies seek to benefit from efficiencies in an increasingly cost-sensitive environment for the medical device and health care products they manufacture. Covidien currently has about 1,800 workers in Massachusetts, many of them in Mansfield. The companies did not comment about whether jobs would be moved in or out of Mansfield. Combined, the two companies have 87,000 employees in more than 150 countries. We are excited to reach this agreement with Covidien, which further advances our mission to alleviate pain, restore health and extend life for patients around the world, said Omar Ishrak, Chairman and Chief Executive Officer of Medtronic. Covidien and Medtronic, when combined, will provide patients, physicians and hospitals with a compelling portfolio of offerings that will help improve care and surgical performance, said Jos E. Almeida, Chairman, President and Chief Executive Officer of Covidien. Covidien, while based in the U.S., is incorporated in Ireland. One advantage the merged company would receive is that Medtronic would be able to switch its tax domicile from the United States to Ireland, which has a lower corporate tax rate. The Medtronic-Covidien deal is the latest in a series of Continue reading >>

Judge Dismisses Fraud Suit Against Medtronic

Judge Dismisses Fraud Suit Against Medtronic

Judge dismisses fraud suit against Medtronic Lawsuit claimed devicemaker defrauded the federal government. FILE - In this Aug. 16, 2005, the "Rising Man" symbol stands in front of the Fridley, Minn., based Medtronic. A federal judge in Minnesota has tossed out a lawsuit against Medtronic that claimed the worlds largest device maker had defrauded the federal government by failing to pass along discounts it received for expedited shipping of medical devices to hospitals. U.S. District Judge David Doty ruled this week that the plaintiffs, Bay Area-based Cavallino Consulting, had failed to produce concrete evidence showing that Medtronic knowingly overcharged the government for expedited shipping costs of medical devices to hospitals owned or run by the government. Cavallino argued that Medtronic should have passed along discounts of 35 percent to 65 percent that it purportedly received for expedited shipping from UPS and FedEx, which amounted to millions of dollars in discounts. While that interpretation might not be unreasonable, Doty wrote, the language of Medtronics federal contract doesnt explicitly require the medical device maker to do so. Rather, the contract simply says that government is responsible to pay an extra rate for expedited shipping, notwithstanding any discounts Medtronic might have received. The provision does not clearly require Medtronic to charge government hospitals for expedited shipping costs actually incurred, Doty wrote in his Tuesday order. Absent such clarity, Medtronic could not have knowingly submitted a false claim to the government as that term is defined under the [federal False Claims Act]. Doty also ruled that Cavallino failed to show how any specific device shipment was billed for inappropriately, and it was pure speculation how much Continue reading >>

Medtronic's Move: 'positively Un-american?'

Medtronic's Move: 'positively Un-american?'

Medtronic's move: 'Positively un-American?' There's a problem with American companies moving overseas, says Fortune Editor-at-Large Allan Sloan. When companies avoid taxes, they're leaving Americans to pay the bill, he said. It's perfectly legal for a company to leave the country, he wrote in a recent article , but it threatens to undermine America's tax base. A company does this by reincorporating in a place like Ireland, where the corporate tax rate is 12.5%, compared with 35% in the U.S. Inversion also makes it easier to divert what would normally be U.S. earnings to foreign, lower-tax locales. But being legal isn't the same as being right. If a few companies invert, it's irritating but no big deal for our society. But mass inversion is a whole other thing, and that's where we're heading. If companies can legally dodge corporate taxes in the U.S., is there any reason they should not? Should Congress put a stop to this, but risk losing some American companies to other countries? Leave your thoughts below. The news on your schedule from MPR News Update Continue reading >>

Medtronic-covidien: The End Of The American Dream?

Medtronic-covidien: The End Of The American Dream?

Medtronic-Covidien: The End of the American Dream? A growing number of drug and device makers are more than willing to abandon U.S. headquarters and the implications for the U.S. are sobering. One company after another has begun searching for acquisitions that would allow them to enjoy a lower tax rate by purchasing a rival based in certain foreign countries and then shifting headquarters there. The maneuver has a technical name called tax inversion, but in reality, its all about taxaversion. And the trend is accelerating. Over the past year, drug makers were busy concocting such dealsActavis bought Warner-Chilcott, while Perrigo acquired Elan. Recently, Pfizer attempted such a move in its failed quest to take over AstraZeneca , which might still happen. Now, Medtronic, a big device maker, may pay $40 billion for Covidien after reportedly eyeing Smith & Nephew, both of which are based overseas. Caravan Migrants Seek Asylum at U.S.-Mexico Border

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  • Medtronic Acquires Chanhassen Firm For $200 Million

    Medtronic Acquires Chanhassen Firm For $200 Million

    Eden Prairie woman dies from snowstorm crash injuries Medtronic is paying $200 million to acquire Cardiocom, a private company based in Chanhassen with telecommunication tools for managing chronic diseases, the Fridley-based manufacturer announced Monday. The acquisition is meant to help Medtronic expand beyond the medical device market into the world of health services, with a focus on helping heart-failure patients stay out of the hospital. Cardiocoms products include weight scales, blood pressure monitors and pulse oximeters that can electronically communicate health information to a nurse call center. Based on the information, the companys nurses can alert primary care physicians when symptoms suggest a patient is at risk of needing a return trip to the hospital. Doctors, in turn, can intervene to help patients stay well at home, said Mike Genau, senior vice president and president of Medtronics U.S. region. Hospitals are saying to us: Medtronic, how can you help us reduce the level of readmits? Genau said. The Cardiocom products and services are given to the patient upon discharge (from) the hospital. Reducing hospital readmissions is a hot topic in health care. Beginning last year, the federal government started issuing financial penalties against hospitals with excess readmissions involving Medicare patients treated for heart attacks, heart failure and pneumonia. Hospitals with poor readmission scores can receive a decrease in base operating payments from Medicare of up to 2 percent. Private health insurers also are interested in reducing the number of readmissions, which explains why health plans also have been Cardiocom customers, Genau said. Medtronic is one of the worlds largest manufacturers of medical devices, including pacemakers and implanted defibrillat Continue reading >>

    Reading Eagle - Reading, Pa | Our City | Readingeagle.com

    Reading Eagle - Reading, Pa | Our City | Readingeagle.com

    FILE - In this Aug. 16, 2005, the "Rising Man" symbol stands in front of the Fridley, Minn., based Medtronic. Medtronic said Wednesday, Nov. 18, 2009, it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division. Medtronic said Wednesday it is responding to a warning letter from the Food and Drug Administration about procedures at the Minnesota headquarters of its heart implants division. Medtronic said the FDA inspected the Mounds View, Minn., location in August. It found problems with Medtronic's procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues. The agency also cited problems with Medtronic's quality control for suppliers. Medtronic is the world's largest medical device maker, and the cardiac rhythm disease management unit is its largest business. It makes surgically implanted devices for rapid, slow, and irregular heartbeats, and systems that monitor how those products are working. The FDA feels Medtronic's planned corrections are sufficient to fix the problems, Medtronic said. The Minneapolis company has 15 days to respond to the warning and said it has already started making changes. In May, the cardiac rhythm disease unit recalled thousands of pacemakers due to a wiring defect that made them unresponsive or caused them to run out of battery power. The recall was deemed a Class I recall by the FDA, meaning the malfunction could seriously injure or kill patients. In midday trading, Medtronic shares lost 40 cents to $39.80. Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. 345 Penn Street . Continue reading >>

    Former Medtronic Ceo: Company Should Go Ahead With Covidien Merger

    Former Medtronic Ceo: Company Should Go Ahead With Covidien Merger

    Former Medtronic CEO: Company should go ahead with Covidien merger Bill George: Professor of management practice at Harvard Business School and former chairman and chief executive officer of Medtronic Former Medtronic CEO Bill George says he hopes the company will proceed with its controversial merger with Ireland-based Covidien. The deal is subject to new U.S. Treasury department rules designed to make so-called tax inversion deals less financially attractive. Medtronic says it's studying the provisions. The company would have to pay Covidien a so-called "break-up fee" of up to $850 million if Medtronic backs out. But George says that won't be a major consideration as Medtronic decides how to proceed. "That's 2 percent of the deal, of a $43 billion deal," George said. "The deal is worth a lot more value than that. It's going to produce a lot more profit than that in year one. So I don't think that is going to be the deciding factor here." Medtronic's share price fell as much as 4 percent Tuesday following the Treasury department's Monday evening announcement of new provisions. A tax inversion involves a U.S. firm merging with a foreign company, and reducing its US tax bill. George spoke to The Daily Circuit's Tom Weber. Continue reading >>

    Jury Rules Medtronic Violated Patent, Awards $392.5 Million

    Jury Rules Medtronic Violated Patent, Awards $392.5 Million

    Eden Prairie woman dies from snowstorm crash injuries Edwards Lifesciences Corp., awarded more than $392 million in a patent-infringement lawsuit against Medtronic Inc., plans to ask a judge to prevent its rival from selling a new heart-valve device in the U.S. Medtronic was set to begin selling its CoreValve by April pending Food and Drug Administration clearance, one of the biggest medical-device approvals anticipated by investors this year. Edwards has had the U.S. market to itself for the aortic valves inserted without cracking the chest since November 2011. Both devices are sold outside the U.S. in a market expected to reach $3 billion by 2019. Medtronic said it plans to appeal todays jury decision on Edwardss Cribier patent. Medtronic failed before to appeal a separate decision on the Anderson patent and paid Edwards $84 million in initial damages last year in a case thats still pending. Its unclear when a decision or an injunction will come. Its a high hurdle, said Edwards Chief Executive Officer Mike Mussallem in an interview at the JPMorgan Chase & Co. health-care conference in San Francisco. In general you dont commonly see injunctions, but you have pretty decisive facts in this case. And now the same judge saw two juries find willful infringement. It will be interesting to see what the judge does with that. Were hopeful. Shares of Edwards, based in Irvine, Calif., gained 1.8 percent to $71.89. Fridley-based Medtronic fell less than 1 percent to $59.33. The lawsuit over the Cribier patent was filed in federal court in Santa Ana, Calif., in June 2011 and transferred the following year to Wilmington, Del.. Edwards will seek triple damages because the jury ruled Medtronics infringement was intentional, Mussallem said. There are about 300,000 people worldwide wit Continue reading >>

    Fda Says Recalled Medtronic Guidewires Are Potentially Deadly, Deems Class I: Food And Drug Recalls

    Fda Says Recalled Medtronic Guidewires Are Potentially Deadly, Deems Class I: Food And Drug Recalls

    FDA says recalled Medtronic guidewires are potentially deadly, deems Class I: Food and Drug recalls Medtronic announced Friday, Nov. 15, 2013, that the Food and Drug Administration recall of 15,000 guidewires had been classified as Class I, a category reserved for products with reasonable potential to cause serious injury or death. In this 2005 photo, The "Rising Man" symbol stands in front of the Fridley, Minn. offices of Medtronic. (AP Photo/Jim Mone) CLEVELAND, Ohio-- After investigating complaints from patients, The Food and Drug Administration (FDA) has classified the recently recalled guidewires used in heart procedures manufactured by Minneapolis-based Medtronic, Inc . as potentially fatal. Medtronic began its recall of the Interventional Wires and ATTAIN HYBRID wires in October, after receiving complaints from four patients, including one patient injury. After reviewing the reports, the FDA deemed the recall a Class I , meaning that "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The problem-- the coating of the wires can detach and cause clots -- can lead to stroke or heart attack, the company says. The guidewires are inserted into an artery to guide a catheter in percutaneous coronary interventions, which help open up blood flow with a stent or other device during a heart attack. They also help the placement of left ventricular leads for cardiac rhythm devices, Medtronic said in a statement. In 2007, Medtronic recalled its Sprint Fidelis defibrillation leads because of the potential for lead fractures and a number of deaths and serious injuries potentially linked to their use. You can see a full list of the recalled Guidewires here . If you think you've been harmed Continue reading >>

    How The Medtronic 670g Artificial Pancreas Works: Faq

    How The Medtronic 670g Artificial Pancreas Works: Faq

    On September 28, the FDA announced that it has approved Medtronic Diabetes’ MiniMed 670G system, the world’s first pump/sensor system to be able to dose insulin on its own. Previous systems were able to stop insulin delivery when your blood glucose values dropped too low (or, if you were in the EU, to predictively suspend basal insulin). But the 670G actually uses data from the sensor to give you insulin. This is an enormous step toward a genuine closed loop/artificial pancreas system, and is a really big deal. Q: But what does it actually do and how does it work? A: Basically, the goal of the pump/sensor (henceforth known as the 670G system) is to keep you at or close to 120 mg/dl as consistently as possible. Right now your only choices, in terms of target, are 120 mg/dl and 150 mg/dl (in case you want to be really conservative), though Medtronic hopes that future systems might be approved to allow people to set their own targets. How the Medtronic 670G Artificial Pancreas Works How it works: You and your healthcare team come up with a set of initial basal rates and you program those into the pump like normal. You also program in your insulin-to-carb ratios as accurately as you possibly can. That’s when things get crazy: instead of programming in your own boluses and corrections, the only thing you tell the pump (other than giving it calibrations for the CGM) is the number of carbs you’re eating at that meal. It gives you a dose of insulin based on your pre-entered insulin-to-carb ratio, and then automatically makes microadjustments and corrections afterwards, with the goal of getting you to 120 mg/dl. For example, let’s say that you are eating a lunch with 30 grams of carb, and you have a 1:15 insulin-to-carb ratio programmed for that time of day. The only t Continue reading >>

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