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November 13, 2012
11:25 EDTMDT, EWCourt affirms Edwards patents infringed, says injunction should be reconsidered
Edwards Lifesciences (EW) sued defendants CoreValve, a unit of Medtronic (MDT), over patent infringement related to a prosthetic device called a “transcatheter heart valve.” A district court jury ruled Edwards' patent to be valid and infringed by CoreValve and awarded damages of $72.65M in lost profits and $1.28M as a reasonable royalty. The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The lower court also declined to issue an injunction against future infringement. The United States Court of Appeals for the Federal Circuit affirmed the district court’s rulings, except the appeals court remanded for reconsideration the lower court’s denial of an injunction.
News For EW;MDT From The Last 14 Days
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April 27, 2015
15:35 EDTMDTMedtronic announces consent decree with FDA for Synchromed system
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15:31 EDTMDTFDA enters consent decree with Medtronic
The FDA announced the filing of a consent decree against Medtronic and two of the company’s officers—S. Omar Ishrak and Thomas Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured. The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
11:02 EDTMDTMedtronic begins clinical study of Endurant Evo AAA strent graft system
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April 23, 2015
19:16 EDTEWOn The Fly: After Hours Movers
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16:19 EDTEWEdwards Lifesciences sees Q2 EPS $1.00-$1.10, consensus $1.05
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16:18 EDTEWEdwards Lifesciences narrows FY15 EPS view to $4.10-$4.30, consensus $4.21
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16:17 EDTEWEdwards Lifesciences reports Q1 EPS $1.12, consensus $1.04
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15:00 EDTEWNotable companies reporting after market close
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April 21, 2015
11:02 EDTMDTMedtronic begins enrollment in feasibility study of Valiant Mona LSA system
Medtronic announced the start of a new feasibility study to evaluate the safety and effectiveness of the Valiant Mona LSA branch thoracic stent graft system, an investigational medical device designed to enable a completely endovascular solution for aortic aneurysms encroaching on the left subclavian artery. Cleveland Clinic cardiothoracic surgeon Dr. Eric Roselli successfully completed the first implant in the study on Thursday. He serves as the study's national primary investigator and receives consulting fees and honoraria for teaching from Medtronic. The study aims to enroll 24 subjects at up to seven sites in the United States. The purpose of the study is to characterize the safety and effectiveness of the investigational device acutely and at 30 days.
April 17, 2015
07:10 EDTMDTMedtronic's Solitaire improved neurological outcomes in stroke patients in trial
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April 14, 2015
11:04 EDTMDTMedtronic to develop stent graft system under patent agreement with Sanford
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09:16 EDTMDTMedtronic announces CE Mark for Micra TPS
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