Edition:
United States

Edwards Lifesciences Corp (EW.N)

EW.N on New York Stock Exchange

212.04USD
23 Aug 2019
Change (% chg)

$-4.63 (-2.14%)
Prev Close
$216.67
Open
$216.67
Day's High
$217.37
Day's Low
$210.88
Volume
288,078
Avg. Vol
329,979
52-wk High
$226.31
52-wk Low
$136.47

Latest Key Developments (Source: Significant Developments)

FDA Identifies Edwards Lifesciences' Sapien Heart Valve Recall As Class I
Thursday, 22 Aug 2019 11:34am EDT 

Aug 22 (Reuters) - U.S. FDA::EDWARDS LIFESCIENCES RECALLS SAPIEN 3 ULTRA DELIVERY SYSTEM DUE TO BURST BALLOONS DURING SURGERY, WHICH MAY RESULT IN VASCULAR INJURY, BLEEDING, OR SURGICAL INTERVENTION.FDA - 17 INJURIES & 1 DEATH REPORTED AT TIME WHEN EDWARDS INITIATED FIELD CORRECTIVE ACTION IN JULY ON SAPIEN 3 ULTRA DELIVERY SYSTEM .FDA SAYS HAS IDENTIFIED EDWARDS LIFESCIENCES LLC'S SAPIEN 3 RECALL AS A CLASS I RECALL.FDA - EDWARDS LIFESCIENCES RECALLED 1,585 SAPIEN 3 DEVICES IN U.S..  Full Article

Edwards Sapien 3 Tavr Receives FDA Approval For Low-Risk Patients
Friday, 16 Aug 2019 11:55am EDT 

Aug 16 (Reuters) - Edwards Lifesciences Corp ::EDWARDS SAPIEN 3 TAVR RECEIVES FDA APPROVAL FOR LOW-RISK PATIENTS.SAPIEN 3 TAVR'S LOW-RISK APPROVAL WAS BASED ON DATA FROM LANDMARK PARTNER 3 TRIAL.  Full Article

Edwards Lifesciences Files For Potential Mixed Shelf Offering
Friday, 26 Jul 2019 05:24pm EDT 

July 27 (Reuters) - Edwards Lifesciences Corp ::EDWARDS LIFESCIENCES CORP FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILING.  Full Article

Edwards Comments On Updated Tavr National Coverage Determination
Friday, 21 Jun 2019 06:18pm EDT 

June 21 (Reuters) - Edwards Lifesciences Corp ::EDWARDS COMMENTS ON UPDATED TAVR NATIONAL COVERAGE DETERMINATION.EDWARDS LIFESCIENCES CORP - COMPANY IS NOT UPDATING OR CHANGING ITS FINANCIAL GUIDANCE.  Full Article

Neovasc Resolves Three Claims For Correction Of Patent Inventorship Made By Edwards Lifesciences CardiAQ LLC
Wednesday, 17 Apr 2019 03:42pm EDT 

April 17 (Reuters) - Neovasc Inc ::NEOVASC ANNOUNCES RESOLUTION OF LAST REMAINING ACTIVE LITIGATION.NEOVASC - HAS RESOLVED THREE CLAIMS FOR CORRECTION OF PATENT INVENTORSHIP MADE BY EDWARDS LIFESCIENCES CARDIAQ LLC IN U.S. COURT.  Full Article

Boston Scientific, Edwards Lifesciences Agree To Global Litigation Settlement
Tuesday, 15 Jan 2019 06:55am EST 

Jan 15 (Reuters) - Boston Scientific Corp ::BOSTON SCIENTIFIC, EDWARDS LIFESCIENCES AGREE TO GLOBAL LITIGATION SETTLEMENT.BOSTON SCIENTIFIC CORP - ALL PATENT LITIGATION BETWEEN COMPANIES TO BE DISMISSED.BOSTON SCIENTIFIC CORP - EDWARDS HAS MADE A ONE-TIME PAYMENT TO BOSTON SCIENTIFIC OF $180 MILLION.BOSTON SCIENTIFIC CORP - ANY INJUNCTIONS CURRENTLY IN PLACE WILL BE LIFTED.BOSTON SCIENTIFIC CORP - NO FURTHER ROYALTIES WILL BE OWED BY EITHER PARTY UNDER AGREEMENT.BOSTON SCIENTIFIC CORP - CO & EDWARDS TO SETTLE ALL OUTSTANDING PATENT DISPUTES BETWEEN THEM.  Full Article

Edwards' Sapien 3 Ultra Transcatheter Heart Valve Receives FDA Approval
Friday, 28 Dec 2018 08:30am EST 

Dec 28 (Reuters) - Edwards Lifesciences Corp ::EDWARDS' SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE RECEIVES FDA APPROVAL.  Full Article

Edwards Lifesciences Corp - Sees 2018 Adjusted Sales At Higher End Of $3.5-3.9 Billion
Wednesday, 5 Dec 2018 09:30am EST 

Edwards Lifesciences Corp ::EDWARDS LIFESCIENCES OUTLINES GROWTH STRATEGY AT ANNUAL INVESTOR CONFERENCE.REAFFIRMING OCTOBER 2018 FINANCIAL GUIDANCE.PROJECTED 2019 GLOBAL SALES $3.9-4.3 BILLION.ESTIMATED 2019 ADJUSTED EARNINGS PER SHARE $5.05-5.30.FOCUSED LONG-TERM GROWTH INVESTMENTS WITH 2019 RESEARCH AND DEVELOPMENT PLANNED AT 17-18% OF SALES.SEES 2019 UNDERLYING SALES GROWTH 9-12%.PROJECTED 2019 TAVR SALES $2.4-2.7 BILLION; UNDERLYING GROWTH 11-15%.FAVORABLE PARTNER 3 TRIAL RESULTS EXPECTED IN MARCH; COMMERCIAL APPROVAL IN LATE 2019.SEES FY 2019 FREE CASH FLOW $800-900 MILLION.EXPECTS TO LAUNCH KONECT SYSTEM IN 2019 IN BOTH U.S. AND EUROPE.FY2018 EARNINGS PER SHARE VIEW $4.70, REVENUE VIEW $3.81 BILLION -- REFINITIV IBES DATA.FY2019 EARNINGS PER SHARE VIEW $5.20, REVENUE VIEW $4.17 BILLION -- REFINITIV IBES DATA.SEES 2018 ADJUSTED EPS $4.60-$4.75.SEES 2018 ADJUSTED SALES AT HIGHER END OF $3.5-3.9 BILLION.SEES 2018 ADJUSTED FREE CASH FLOW HIGHER END $700-775 MILLION.  Full Article

Edwards Lifesciences Says Reports Qtrly Adjusted Earnings Per Share $1.07
Tuesday, 23 Oct 2018 04:15pm EDT 

Oct 23 (Reuters) - Edwards Lifesciences Corp ::EDWARDS LIFESCIENCES - QTRLY EARNINGS PER SHARE $1.06; QTRLY ADJUSTED EARNINGS PER SHARE $1.07; QTRLY SALES $907 MILLION, UP 10 PERCENT.EDWARDS LIFESCIENCES - QTRLY ADJUSTED. SALES $921 MILLION, UP 11 PERCENT.EDWARDS LIFESCIENCES - RECONFIRMED 2018 TOTAL COMPANY ADJUSTED SALES AND EPS GUIDANCE RANGES.EDWARDS LIFESCIENCES - QTRLY THVT SALES $558 MILLION, UP 16 PERCENT; UP 13 PERCENT ON AN UNDERLYING BASIS.EDWARDS LIFESCIENCES - REMAINS ON TRACK TO RECEIVE CE MARK OF SAPIEN 3 ULTRA SYSTEM IN Q4.EDWARDS LIFESCIENCES - Q3 CARDIOBAND SYSTEM SALES, INCLUDED IN THVT, WERE LIMITED DUE TO ONGOING SUPPLY CONSTRAINT THAT IS EXPECTED TO CONTINUE IN Q4.EDWARDS LIFESCIENCES SEES Q4 ADJUSTED. SALES TO BE BETWEEN $950 MILLION AND $1 BILLION; SEES Q4 ADJUSTED. EARNINGS PER SHARE OF $1.05 TO $1.20.Q3 EARNINGS PER SHARE VIEW $1.02, REVENUE VIEW $928.2 MILLION -- THOMSON REUTERS I/B/E/S.Q4 EARNINGS PER SHARE VIEW $1.21, REVENUE VIEW $995.4 MILLION -- THOMSON REUTERS I/B/E/S.FY2018 EARNINGS PER SHARE VIEW $4.68, REVENUE VIEW $3.83 BILLION -- THOMSON REUTERS I/B/E/S.EDWARDS LIFESCIENCES - Q4 THVT UNDERLYING SALES GUIDANCE MODERATED; CRITICAL CARE GUIDANCE RAISED.  Full Article

Edwards Lifesciences Corp Comments On German Court Decision
Tuesday, 23 Oct 2018 07:30am EDT 

Oct 23 (Reuters) - Edwards Lifesciences Corp ::EDWARDS COMMENTS ON GERMAN COURT DECISION.EDWARDS LIFESCIENCES- DISTRICT COURT IN GERMANY, GRANTED BOSTON SCIENTIFIC'S REQUEST FOR A PRELIMINARY INJUNCTION ON FUTURE COMMERCIAL SALES.EDWARDS LIFESCIENCES CORP - INJUNCTION WILL ONLY BECOME EFFECTIVE IF BOSTON SCIENTIFIC ENFORCES IT AND PROVIDES A BOND OF EUR 10 MILLION.EDWARDS LIFESCIENCES-SAPIEN 3 ULTRA VALVE NOT YET APPROVED FOR COMMERCIAL SALE & SUBJECT OF CLINICAL STUDY FOR EUROPEAN APPROVAL, WHICH WILL CONTINUE.EDWARDS LIFESCIENCES CORP - COOURT'S DECISION HAS NO EFFECT ON SALES OF CO'S SAPIEN 3 OR CENTERA VALVES.  Full Article

FDA pegs Edwards Lifesciences Sapien delivery system recall as severest

The U.S. health regulator on Thursday categorized the recall of Edwards Lifesciences Corp's Sapien 3 Ultra delivery system as extremely serious, highlighting health risks associated with its use, but the products will remain on the market.