BioWorld - Tuesday, December 10, 2019

Cardiovascular, BioWorld MedTech
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Edwards rolls out 2020 guidance with TAVR optimism, slow pace on mitral and tricuspid

December 6, 2019
By Stacy Lawrence
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Edwards Lifesciences Corp. added more than $20 billion so far this year to its market cap to exceed a $50 billion valuation. Executives worked to convince Wall Street that 2020 and beyond are lining up to be additional banner years for the cardiovascular med-tech giant at the company’s annual investor meeting. While the newly introduced guidance for next year from Edwards was largely in line or a bit better than analysts had anticipated, its share price remained relatively flat on the event.
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Novoheart, Astrazeneca to co-create stem cell-based heart failure model

December 2, 2019
By Meg Bryant
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Heart failure with preserved ejection fraction (HFpEF), also known as diastolic heart failure, accounts for roughly half of all heart failure cases worldwide. The condition, which occurs when the ventricles do not relax as they fill with blood following heart muscle contractions, is especially common in elderly women, striking up to 10% of those over 80 years old. Now stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of HFpEF. The goal is to give drug researchers critical clues of a drug candidate’s efficacy before it is tested in patients.
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Medtronic’s In.Pact AV DCB wins FDA nod

November 21, 2019
By Meg Bryant
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The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
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Livanova unveils plans to restructure heart valve business, end TMVR program

November 21, 2019
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London-based Livanova plc is exiting its Caisson transcatheter mitral valve replacement (TMVR) program as it looks to restructure its heart valve business. According to the company, the heart valve business line represented nearly $130 million in revenue for full-year 2018 and experienced a revenue decline over the last five years. It attributed the declines to multiple market conditions.
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