New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
April 13, 2014
15:10 EDTEW, MDTMedtronic says CoreValve ruling has no impact outside U.S.
The Federal District Court of Delaware granted in part Edwards Lifesciences' (EW) motion for a preliminary injunction that prevents Medtronic (MDT) from selling or offering to sell its CoreValve System in the United States. The ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials. At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued. In addition, the court ordered Medtronic and Edwards Lifesciences to enter into discussions immediately to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant, CoreValve or the Edwards device, free from the limitations of the injunction. The court stated that CoreValve is a 'safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.' The court also found that the public interest favors enforcement of patent rights. The CoreValve System received approval from the FDA in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial.
News For MDT;EW From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
May 26, 2015
09:54 EDTMDTMedtronic looking for deals in China, WSJ reports
Subscribe for More Information
May 21, 2015
20:04 EDTMDTMedtronic CEO sees untapped potential in India, Times of India says
Subscribe for More Information
May 20, 2015
09:34 EDTMDTMedtronic announces new data for drug-coated balloon
Subscribe for More Information
07:16 EDTMDTLeerink to hold a booth tour at EuroPCR
Subscribe for More Information
05:30 EDTEWEdwards Lifesciences announces outcomes for patients treated with SAPIEN 3 valve
Edwards Lifesciences announced that 30-day outcomes for intermediate-risk patients treated transfemorally with the SAPIEN 3 transcatheter aortic valve at centers in Europe and Canada demonstrated very low mortality and stroke rates, and no severe paravalvular leaks. These independently adjudicated data are consistent with the outcomes recently reported in a similar study of 1,000 patients treated at 51 centers in the United States. In the multi-center study of 101 intermediate-risk patients, all-cause mortality was 1 percent. The frequency of other important complications was also low: the disabling stroke rate was 2 percent, major vascular complications were 2 percent and the permanent pacemaker rate was 4 percent. The investigators also noted that the SAPIEN 3 valve had excellent hemodynamic performance, with very low incidence of significant paravalvular regurgitation, as only 2.3 percent of patients had moderate paravalvular leaks and there were no reports of severe leaks.
May 19, 2015
09:21 EDTEWEdwards Lifesciences voluntarily pauses enrollment for Fortis clinical program
Subscribe for More Information
08:48 EDTEWEdwards Lifesciences reports positive results from treatment with SAPIEN 3
Subscribe for More Information
08:40 EDTMDTMedtronic sees FY15 revenue $20.3B, may not compare to consensus $28.15B
Subscribe for More Information
08:40 EDTMDTMedtronic sees Q4 adjusted EPS at upper half of $1.08-1.13, consensus $1.10
Subscribe for More Information
May 18, 2015
09:27 EDTMDTMedtronic announces study results showing CRT system optimizes treatment
Subscribe for More Information
May 15, 2015
13:33 EDTMDTMedtronic: TYRX antibacterial envelope reduces cardiac device infection rates
Subscribe for More Information
08:12 EDTMDTMedtronic Micra TPS meets initial safety, performance measures
Subscribe for More Information
May 14, 2015
13:34 EDTMDTMedtronic: Micra transcatheter pacemaker meets initial safety measures in study
Subscribe for More Information
13:31 EDTMDTMedtronic says Evera MRI ICD study meets safety, efficacy endpoints
Subscribe for More Information
09:41 EDTMDTLeerink medical devices analyst holds a cardiology luncheon meeting
Subscribe for More Information
May 12, 2015
10:02 EDTMDTMedtronic receives FDA approval and CE Mark for Advance ST cryoballoon
Subscribe for More Information
10:01 EDTEWOn The Fly: Analyst Upgrade Summary
Subscribe for More Information
06:48 EDTEWEdwards Lifesciences upgraded to Overweight from Neutral at JPMorgan
JPMorgan upgraded Edwards Lifesciences to Overweight following the 15% selloff since mid-March. The firm says its confidence in the conversion of the surgical valve replacement market to transcatheter replacement increased significantly at this year's ACC. It adds that its recent field work indicates the TAVR market has accelerated post-ACC. JPMorgan raised its price target for shares to $155 from $147.
06:35 EDTEWEdwards Lifesciences upgraded to Overweight from Neutral at JPMorgan

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use