Cardiac

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    Courtesy of Edwards Lifesciences
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    CMS proposes Medicare coverage for transcatheter tricuspid replacement

    Edwards submitted a request for a national coverage determination in February, after receiving FDA approval for its Evoque device earlier that month.

    By • Dec. 20, 2024
  • CMR Surgical Co-founder and CMO Mark Slack stands with his arms crossed in front of a Versius robot.
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    Permission granted by CMR Surgical
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    Robots, AI and PFA: The top medtech Q&As of 2024

    From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.

    By • Dec. 20, 2024
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    Sarah Silbiger via Getty Images
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    Trendline

    Medical device safety in spotlight after high profile recalls

    From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

    By MedTech Dive staff
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    Foremniakowski via Getty Images
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    Heart valve developer Anteris launches IPO

    IPOs in medtech have been sparse, but some analysts said improving market conditions could support a revival of offerings in 2025.

    By • Dec. 20, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific updates cryoablation catheter instructions after 4 death reports

    The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.

    By • Dec. 19, 2024
  • Merit Medical President Joseph Wright wears a light blue shirt, gray jacket and glasses in a headshot.
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    Retrieved from Merit Medical on December 17, 2024
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    Merit Medical president to resign after unspecified conduct allegations

    Joseph Wright’s resignation is effective in January, and CEO and founder Fred Lampropoulos has been reappointed president.

    By • Dec. 18, 2024
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    PFA to surpass radiofrequency ablation in 2025: Citi survey

    Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as Medtronic, Boston Scientific and Johnson & Johnson battle for market share.

    By • Dec. 16, 2024
  • Capstan employee Evelyn Haynes is wearing blue gloves while working on the company's heart valve device.
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    Permission granted by Capstan Medical
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    Capstan Medical raises $110M for heart valve with robotic system

    The startup’s third round of financing includes support from Intuitive Surgical’s venture capital arm.

    By • Dec. 12, 2024
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    JuSun via Getty Images
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    Artivion says cybersecurity incident has disrupted order, shipping processes

    The heart device manufacturer has taken certain systems offline in response to the incident, which involved the acquisition and encryption of files.

    By • Dec. 11, 2024
  • A picture of black and white medical images of a heart on a computer screen.
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    Retrieved from Cleerly on December 06, 2024
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    Cleerly raises $106M to fund AI-driven heart disease tool

    The company has generated evidence that shows its system is better than experts at assessing vessel narrowing, plaque volume and composition.

    By • Dec. 6, 2024
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards expects new TAVR approval in mid-2025 to boost sales

    U.S. approval of an expanded indication for transcatheter aortic valve replacement in patients without symptoms is among the growth catalysts Edwards outlined in an investor day presentation.

    By • Dec. 5, 2024
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    Violeta Stoimenova via Getty Images
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    Haemonetics to offload whole-blood business for up to $67M

    Selling the assets to Italy’s GVS should help Haemonetics improve its revenue growth and profit margins, analysts said.

    By • Dec. 4, 2024
  • A large group of dosing pens for subcutaneous injection of anti-obesity medication piled in a heap.
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    aprott via Getty Images
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    Biden administration proposes Medicare, Medicaid coverage of pricey weight loss drugs

    About 7.4 million Americans with obesity could have insurance coverage for drugs like Wegovy if the Trump administration allows the rule to go into effect — at the cost of $40 billion to federal and state governments.

    By Rebecca Pifer • Nov. 27, 2024
  • The exterior of Medtronic's Minnesota operational headquarters is shown along with its reflection in a pool of water.
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    Courtesy of Medtronic
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    Medtronic’s ablation sales slowed by PFA supply issues

    CEO Geoff Martha said the business did not meet internal growth expectations last quarter due to third-party supply issues that have now been resolved.

    By • Nov. 19, 2024
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific’s Watchman could be new option for patients post ablation: study

    The trial compared the stroke prevention device for left atrial appendage closure to blood thinners in people who underwent cardiac ablation for AFib.

    By • Nov. 18, 2024
  • A photo of Johnson & Johnson's pulsed field ablation system for atrial fibrillation.
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    Courtesy of Johnson & Johnson
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    The PFA race is heating up. Here’s where the market stands after J&J’s approval.

    Boston Scientific, Medtronic and J&J are moving quickly to secure their place in the fast-growing pulsed field ablation space as new devices and heart imaging technology hit the market.

    By • Nov. 18, 2024
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    Photo illustration: Shaun Lucas/Industry Dive; Getty Images

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    Haemonetics to close California facility, lay off 75 people

    Over the past year, Haemonetics has reshaped its product portfolio through restructuring and M&A, adding devices used in cardiology procedures.

    By • Nov. 14, 2024
  • Boston Scientific's Farapulse pulsed field ablation device.
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    Permission granted by Boston Scientific
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    Boston Scientific resumes PFA trial in new patient group after pausing enrollment

    Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.

    By • Nov. 12, 2024
  • A picture of a blue pulsed field ablation catheter against a gray background.
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    Courtesy of Johnson & Johnson
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    J&J wins FDA approval for Varipulse PFA system

    J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

    By • Nov. 7, 2024
  • A coil-shaped device is shown moving through a tube with branching structures around it.
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    Courtesy of Medtronic
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    Medtronic, Recor win CMS transitional payment coverage for renal denervation devices

    Patient and physician education is the next challenge to change the treatment paradigm for drug-resistant hypertension, Citi Research analyst Joanne Wuensch said.

    By • Nov. 5, 2024
  • A view of the Edwards Lifesciences headquarters building with three people walking in front.
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    Courtesy of Edwards Lifesciences
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    Edwards, Medtronic and Inari share trial data at TCT conference

    The three medtech firms unveiled new data this week during TCT 2024 in Washington, D.C. Here’s what the results mean for the companies and their device markets.

    By • Oct. 31, 2024
  • Boston Scientific's Acurate neo2 TAVR device is shown close up against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study

    Analysts said the findings complicate the outlook for a U.S. launch of Boston Scientific's aortic valve replacement device.

    By • Oct. 31, 2024
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    Edwards Lifesciences
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    Edwards data show benefit of early TAVR over ‘watchful waiting’

    Study author Philippe Genereux said the trial data “shatter 60 years of ingrained belief on the treatment for severe aortic stenosis.”

    By • Oct. 29, 2024
  • An illustration of a heart bump inserted into a heart against a blue background.
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    Courtesy of Abiomed
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    J&J to seek FDA approval after small-bore Impella heart pump hits trial goal

    The company has predicted the narrower Impella ECP will be easier to insert and implant, as well as enable the use of small bore access and closure techniques.

    By • Oct. 29, 2024
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    Boston Scientific to close Silk Road Medical headquarters, lay off 138 people

    Following its acquisition of Silk Road in September, Boston Scientific said it plans to consolidate the company’s work in Minnesota.

    By • Oct. 28, 2024
  • An image of Edwards Lifesciences' Irvine, California, campus at dusk.
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    Courtesy of Edwards Lifesciences
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    Edwards’ TAVR sales faced ongoing hospital constraints in Q3

    Hurt by a slowdown in procedures for its heart valve replacement devices, Edwards said it is working with hospitals to manage workflow challenges.

    By • Oct. 25, 2024