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Leaked Fresenius memo spurs FDA probe | Legal News - Mass Device |
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The FDA probes Fresenius Medical after more than 900 patients experienced heart attacks at the company's internal dialysis centers, as detailed in a company memo that wasn't shared with other Fresenius dialysis device users.
FDA investigators want answers from Fresenius (NYSE:FMS) after a dialysis website leaked a copy of an internal memo released to the company's in-house dialysis centers.
The memo detailed adverse events possibly associated with improper use of its Granuflo dialysis concentrate, including a possible 5-fold increase in heart-attack risk associated with the compound.
More than 900 patients suffered sudden cardiac arrest at Fresenius dialysis clinics in 2010, according to the memo, and researchers found that patients with elevated levels of bicarbonate in the blood were 5 times more likely to suffer an attack.
Fresenius chief medical officer Dr. Franklin Maddux told reporters that he felt that the data shared with the company's clinics was "not in a condition for general consumption" and that he had no mechanism to warn outside clinics without resorting to medical journals, according to the New York Times.
The Granuflo product contains a compound that creates bicarbonate to help reduce acidity in the blood. Because Granuflo contains a higher concentration of that compound than similar products, physicians must modify the standard bicarbonate prescriptions given to patients for outside-the-clinic use. Patients who receive the standard bicarbonate dose may end up with an excessive amount of bicarbonate in their blood, potentially increasing their risk of sudden cardiac arrest.
Fresenius eventually notified its customers of the bicarbonate risk in March. The 2010 internal memo made its way to RenalWEB, which first reported the story last month, and the FDA announced its investigation about a week later.
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Asia-Pacific Nephrology and Urology Devices Market Outlook to ... - SBWire (press release) |
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Boston, MA -- (SBWIRE) -- 06/19/2012 -- GlobalData's new report, "Asia-Pacific Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters" provides key market data on the Asia-Pacific Nephrology and Urology Devices market - Australia, China, India and Japan. The report provides value (USD million) data for all the market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment. The report also provides company shares and distribution shares data for each of the aforementioned market categories. The report is supplemented with global corporate-level profiles of the key market participants.
View Full Report Details and Table of Contents
This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.
Scope
- Countries covered include Australia, China, India and Japan.
- Market size and company share data for Nephrology and Urology Devices market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment.
- Annualized market revenues (USD million) data for each of the market categories in each of the country. Data from 2004 to 2011, forecast forward for 7 years to 2018.
- 2011 company shares and distribution shares data for each of the market categories and countries.
- Global corporate-level profiles of key companies operating within the Asia-Pacific Nephrology and Urology Devices market..
- Key players covered include Unicharm Corporation, Fresenius Medical Care AG & Co. KGaA, Svenska Cellulosa Aktiebolaget SCA, Nipro Corporation, Gambro AB, Baxter International Inc. and others.
Reasons to Get this Report
- Develop business strategies by identifying the key market categories and segments poised for strong growth.
- Develop market-entry and market expansion strategies.
- Design competition strategies by identifying who-stands-where in the Asia-Pacific Nephrology and Urology Devices competitive landscape.
- Develop capital investment strategies by identifying the key market segments expected to register strong growth in the near future.
- What are the key distribution channels and what's the most preferred mode of product distribution - Identify, understand and capitalize.
Companies Mentioned in this Report: Unicharm Corporation, Fresenius Medical Care AG & Co. KGaA, Svenska Cellulosa Aktiebolaget SCA, NIPRO CORPORATION, Gambro AB, Kimberly-Clark Corporation, Baxter International Inc., Asahi Kasei Corporation, First Quality Enterprises, Inc., NIKKISO CO., LTD., B. Braun Melsungen AG, Coloplast A/S, Covidien plc, HARTMANN GROUP, C. R. Bard, Inc., Dornier MedTech GmbH, ONTEX International N.V., Allengers Medical Systems Ltd., DirexGroup, Siemens Healthcare, Astra Tech Inc., STORZ MEDICAL AG, EDAP TMS S.A., NxStage Medical, Inc.
About Fast Market Research
Fast Market Research is an online aggregator and distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff will help you find the right research to fit your requirements and your budget. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.
Browse all Medical Devices research reports at Fast Market Research
You may also be interested in these related reports:
- Europe Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- South and Central America Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- Middle East and Africa Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- Portugal Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Finland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Switzerland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Egypt Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- United Arab Emirates Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Ireland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Chile Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
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Asia-Pacific Nephrology and Urology Devices Market Outlook to 2018 ... - SBWire (press release) |
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Boston, MA -- (SBWIRE) -- 06/19/2012 -- GlobalData's new report, "Asia-Pacific Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters" provides key market data on the Asia-Pacific Nephrology and Urology Devices market - Australia, China, India and Japan. The report provides value (USD million) data for all the market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment. The report also provides company shares and distribution shares data for each of the aforementioned market categories. The report is supplemented with global corporate-level profiles of the key market participants.
View Full Report Details and Table of Contents
This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.
Scope
- Countries covered include Australia, China, India and Japan.
- Market size and company share data for Nephrology and Urology Devices market categories - Incontinence Devices, Lithotripters and Renal Dialysis Equipment.
- Annualized market revenues (USD million) data for each of the market categories in each of the country. Data from 2004 to 2011, forecast forward for 7 years to 2018.
- 2011 company shares and distribution shares data for each of the market categories and countries.
- Global corporate-level profiles of key companies operating within the Asia-Pacific Nephrology and Urology Devices market..
- Key players covered include Unicharm Corporation, Fresenius Medical Care AG & Co. KGaA, Svenska Cellulosa Aktiebolaget SCA, Nipro Corporation, Gambro AB, Baxter International Inc. and others.
Reasons to Get this Report
- Develop business strategies by identifying the key market categories and segments poised for strong growth.
- Develop market-entry and market expansion strategies.
- Design competition strategies by identifying who-stands-where in the Asia-Pacific Nephrology and Urology Devices competitive landscape.
- Develop capital investment strategies by identifying the key market segments expected to register strong growth in the near future.
- What are the key distribution channels and what's the most preferred mode of product distribution - Identify, understand and capitalize.
Companies Mentioned in this Report: Unicharm Corporation, Fresenius Medical Care AG & Co. KGaA, Svenska Cellulosa Aktiebolaget SCA, NIPRO CORPORATION, Gambro AB, Kimberly-Clark Corporation, Baxter International Inc., Asahi Kasei Corporation, First Quality Enterprises, Inc., NIKKISO CO., LTD., B. Braun Melsungen AG, Coloplast A/S, Covidien plc, HARTMANN GROUP, C. R. Bard, Inc., Dornier MedTech GmbH, ONTEX International N.V., Allengers Medical Systems Ltd., DirexGroup, Siemens Healthcare, Astra Tech Inc., STORZ MEDICAL AG, EDAP TMS S.A., NxStage Medical, Inc.
About Fast Market Research
Fast Market Research is an online aggregator and distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff will help you find the right research to fit your requirements and your budget. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.
Browse all Medical Devices research reports at Fast Market Research
You may also be interested in these related reports:
- Europe Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- South and Central America Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- Middle East and Africa Nephrology and Urology Devices Market Outlook to 2018 - Incontinence Devices, Renal Dialysis Equipment and Lithotripters
- Portugal Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Finland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Switzerland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Egypt Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- United Arab Emirates Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Ireland Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
- Chile Nephrology and Urology Devices Investment Opportunities, Analysis and Forecasts to 2018
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Kidney Injuries Not Likely for Teen Athletes - Renal Business Today |
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PHILADELPHIA—Injury to the kidneys is rare in high school contact sports, researchers found, calling into question the belief of most physicians that teens with only one kidney should not participate in sports.
Among more than 4.4 million instances in which an athlete participated in a game or practice over the course of two academic years, there were only 18 kidney injuries, according to Matthew Grinsell, MD, PhD, of the University of Utah in Salt Lake City, and colleagues.
None was considered catastrophic, resulted in a known loss of kidney function, or required surgical repair, the researchers reported online ahead of the July issue of Pediatrics.
In comparison, during the same time period, there were 3,450 knee injuries, 2,069 injuries to the head, neck, or spine, 1,219 mild traumatic brain injuries, 148 eye injuries, and 17 testicular injuries.
It has been estimated that one in 1,500 individuals is born with a single kidney and surveys have shown that most physicians restrict participation in contact sports for such patients because of concerns about the consequences of losing that organ: dialysis, transplantation, a reliance on immunosuppressant medications for life, and a greater risk for cardiovascular disease.
But there are few data on the actual risk of sports participation in these patients, and the American Academy of Pediatrics (AAP) has recommended a "qualified yes" for participation pending an assessment of each athlete. The academy does not, however, outline specific criteria that could be used to guide a decision.
Grinsell and colleagues side with the AAP, stating that the findings of the current study "do not support limiting sport participation by athletes with single kidneys."
They did, however, suggest a clarification of the recommendation.
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