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News Breaks
August 11, 2014
04:55 EDTRGEN, RGEN, NXTM, NXTM, ABMD, ABMDStephens to hold a bus trip
Medical Technology Boston Bus Trip travels throughout Boston on August 12.
News For RGEN;NXTM;ABMD From The Last 14 Days
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August 18, 2015
10:00 EDTABMDOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Abercrombie & Fitch (ANF) initiated with an Underperform at Wolfe Research... Abiomed (ABMD) initiated with a Buy at CRT Capital... Aeropostale (ARO) initiated with a Peer Perform at Wolfe Research... American Eagle (AEO) initiated with an Outperform, Top Pick at Wolfe Research... American Electric (AEP) initiated with a Buy at Mizuho... Benefitfocus (BNFT) initiated with an Overweight at First Analysis... Blue Buffalo Pet Products (BUFF) initiated with an Equal Weight at Morgan Stanley... Capitala Finance (CPTA) initiated with an Equal Weight at Stephens... Chico's (CHS) initiated with a Peer Perform at Wolfe Research... Children's Place (PLCE) initiated with an Outperform at Wolfe Research... Chimerix (CMRX) initiated with an Outperform at FBR Capital... Ciena (CIEN) initiated with a Market Perform at Northland... Crane (CR) initiated with an Outperform at William Blair... Entergy (ETR) initiated with a Neutral at Mizuho... Express (EXPR) initiated with an Outperform, Top Pick at Wolfe Research... Finisar (FNSR) initiated with a Market Perform at Northland... Francesca's (FRAN) initiated with a Peer Perform at Wolfe Research... Gap (GPS) initiated with an Underperform at Wolfe Research... Infinera (INFN) initiated with an Outperform at Northland... International Game (IGT) initiated with a Buy at Union Gaming... Juno Therapeutics (JUNO) initiated with an Outperform at FBR Capital... L Brands (LB) initiated with a Peer Perform at Wolfe Research... Luca Technologies (LUCA) initiated with an Outperform at Northland... Lumentum (LITE) initiated with an Outperform at Northland... M/A-COM (MTSI) reinstated with a Buy at Jefferies... MRV Communications (MRVC) initiated with an Outperform at Northland... Michael Kors (KORS) initiated with a Peer Perform at Wolfe Research... NN, Inc. (NNBR) initiated with a Buy at Stifel... NeoPhotonics (NPTN) initiated with an Outperform at Northland... Oclaro (OCLR) initiated with an Outperform at Northland... Scientific Games (SGMS) initiated with a Buy at Sterne Agee CRT... SolarCity (SCTY) initiated with a Neutral at UBS... Summit Materials (SUM) initiated with a Neutral at Citi... Tech Data (TECD) initiated with an Underperform at BofA/Merrill... Urban Outfitters (URBN) initiated with a Peer Perform at Wolfe Research... Zumiez (ZUMZ) initiated with an Underperform at Wolfe Research... lululemon (LULU) initiated with a Peer Perform at Wolfe Research.
August 17, 2015
16:11 EDTABMDAbiomed initiated with a Buy at CRT Capital
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08:14 EDTABMDAbiomed announces FDA submission of Impella 2.5, Impella CP, Impella 5.0/LD PMA
Abiomed announced that it has submitted FDA pre-market approval, or PMA, supplemental submissions requesting to expand Impella 2.5 PMA approval to all of the Impella family of devices; Impella 2.5, Impella CP and Impella 5.0/LD. The submissions are for a set of indications related to the use of the Impella devices in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. A request for a longer duration of support is also included. These submissions are proposed as a supplement to the Impella 2.5 PMA approval for high risk percutaneous coronary intervention, or PCI, received on March 23, 2015, and include analysis on 415 patients from the FDA study RECOVER 1 and the U.S. Impella registry, and a relevant Impella literature review that references 692 patients in 17 clinical studies. Additionally, over 24,000 Impella patients supported by Impella devices were reviewed in a safety analysis provided using the FDA/Medical Device Reporting database. Through its review of the supplemental submission, the FDA will ultimately render a decision concerning the safety and efficacy of the Impella CP and the Impella 5.0 in the applied-for patient populations.

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