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Market Wire (Free subscription) | 13/11/2009
IRVINE, CA (MARKET WIRE) Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, is recognizing the contributions of the late William Ganz, M.D., former senior research scientist and staff physician at Cedars-Sinai Medical Center and co-inventor of the Edwards Swan-Ganz pulmonary artery catheter. Dr. Ganz passed away earlier this week...
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A Georgia Lawyer (Free subscription) | 13/11/2009
The FDA has issued a Class I recall of Edwards Lifesciences CardioVations EndoClamp aortic catheter, after reports that the device can rupture during cardiac procedures. The device is a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall....
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GuruFocus Updates (Free subscription) | 13/11/2009
By insider. Chairman & CEO of Edwards Lifesciences Corp. ( EW ) Michael A Mussallem sells 40,000 shares of EW on 11/12/2009 at an average price of $80.52 a share. Read more » »
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Market Wire (Free subscription) | 12/11/2009
IRVINE, CA (MARKET WIRE) Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that The Edwards Lifesciences Fund is granting $1.8 million to 107 nonprofit organizations as part of its fifth annual grant cycle. This fund is a donor-advised fund of the Vanguard Charitable Endowment Program.
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AboutLawsuits.com (Free subscription) | 11/11/2009
A Class I recall has been issued for Edwards Lifesciences CardioVations EndoClamp Aortic Catheters, which are used during heart bypass surgery. The FDA and device manufacturer indicate that the balloon catheters may rupture during surgery, potentially causing a fatal injury for the patient. The aortic balloon catheter recall was announced by the FDA [...]
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Medical Device Recalls since November 03, 2006 (Free subscription) | 11/11/2009
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.
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MassDevice - Medical device news, information and jobs... (Free subscription) | 10/11/2009
The device, a balloon catheter used during bypass operations to block and monitor pressure within the aorta and deliver a drug to stop the heart, "may spontaneously rupture during surgery," according to the FDA recall. Class I recalls are the watchdog agency's most serious, used when there's a "reasonable probability that use of these products will cause serious adverse health consequences...
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FDA MedWatch (Free subscription) | 10/11/2009
Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.
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Food and Drug Adminstration (FDA): CDRHNew (Free subscription) | 09/11/2009
The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.
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Medical Device Recalls since November 03, 2006 (Free subscription) | 07/11/2009
EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes...
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Medical Device Recalls since November 03, 2006 (Free subscription) | 07/11/2009
EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending...
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Market Wire (Free subscription) | 06/11/2009
IRVINE, CA (MARKET WIRE) Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced the first successful Japanese implants of a transcatheter aortic heart valve using its Edwards SAPIEN valve.
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Market Wire (Free subscription) | 04/11/2009
IRVINE, CA (MARKET WIRE) Edwards Lifesciences Corporation (NYSE: EW), a world leader in products and technologies to treat advanced cardiovascular disease, is scheduled to present at the Credit Suisse Annual Healthcare Conference at the Arizona Biltmore hotel in Phoenix, Arizona on Wednesday, November 11, 2009.
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The TTABlog (Free subscription) | 03/11/2009
The Trademark Trial and Appeal Board has scheduled five (5) hearings for the month of November, as listed below. The hearings will be held in the East Wing of the Madison Building, in Alexandria, Virginia. [The hearing schedule and other details regarding attendance may be found at the TTAB website .] Briefs and other papers for these cases may be found at TTABVUE via the links provided. November 4,...
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DeviceSpace (Free subscription) | 02/11/2009
IRVINE, CA and SAN DIEGO, CA--(Marketwire - 11/02/09) - Edwards Lifesciences Corporation, the leader in the sciences of heart valves and hemodynamic monitoring, and DexCom, Inc., a medical device company focused on the design, development and commercialization of continuous glucose monitoring systems, today announced the receipt of CE Mark for an automatic glucose monitoring system. Edwards and DexCom...