• Mashup Score: 9
    SCAI Statement on FDA Circulatory Systems Devices Panel on RDN Systems | SCAI - 8 month(s) ago

    On August 22 and August 23, 2023, the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) convened panels of the Medical Device Committee to review scientific evidence on interventions aimed at reducing blood pressure in patients with hypertension (HTN). The panel discussed, made recommendations and voted on information regarding the premarket approval applications (PMA) for two renal denervation (RDN) systems as tools to reduce blood pressure in adults with uncontrolled HTN,

    Source: scai.org
    Categories: Cardiologists, Latest Headlines
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      SrihariNaiduMD

      RT @SCAI: Just released—read SCAI's Statement on FDA Circulatory Systems Devices Panel on RDN Systems ➡️ https://t.co/85trdtlvbl #CardioNe…

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      SCAI

      Just released—read SCAI's Statement on FDA Circulatory Systems Devices Panel on RDN Systems ➡️ https://t.co/85trdtlvbl #CardioNews #CardioTwitter #RenalDenervation #RDN #InterventionalCardiology #hypertension https://t.co/J8K5kG7lmX

  • Mashup Score: 1
    Medtronic’s Renal Denervation System Fails to Sway FDA Advisory Panel - 8 month(s) ago

    After a long day of debate, an advisory panel of the US Food and Drug Administration concluded today that it could not endorse the premarket approval (PMA) application for use of the Symplicity Spyral (Medtronic) renal denervation device in patie nts whose hypertension is uncontrolled despite the use of BP-lowering therapy, or in patients in whom antihypertensives are poorly tolerated. Members of the Circulatory System Devices panel of the FDA’s Medical Devices Advisory Committee voted fully in support

    Source: www.tctmd.com
    Categories: Cardiology News and Journals, Latest Headlines
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      TCTMD

      RT @vgaldana: Medtronic’s Renal Denervation System Fails to Sway FDA Advisory Panel https://t.co/rZK8qK53Gf #renaldenervation Safety ✅ Eff…

  • Mashup Score: 2
    FDA panel recommends ultrasound renal denervation device for uncontrolled hypertension - 8 month(s) ago

    An FDA advisory panel voted 10-2 that the benefits of an ultrasound renal denervation system outweigh the risk for use in adults with uncontrolled hypertension who are unresponsive or intolerant to antihypertensive medications.In a meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting, members also voted 8-3, with one abstention, that the

    Source: www.healio.com
    Categories: Cardiology News and Journals, Latest Headlines
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      CardiologyToday

      An FDA advisory panel voted 10-2 that the benefits of an ultrasound #RenalDenervation system outweigh the risk for use in adults with uncontrolled #hypertension who are unresponsive or intolerant to antihypertensive medications @US_FDA #Cardiotwitter https://t.co/MFdd0pncpI

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      CardiologyToday

      An FDA advisory panel voted 10-2 that the benefits of an ultrasound #RenalDenervation system outweigh the risk for use in adults with uncontrolled #hypertension who are unresponsive or intolerant to antihypertensive medications @US_FDA #cardiotwitter https://t.co/MFdd0pncpI

  • Mashup Score: 0
    New SCAI Position Statement Highlights the Role of Renal Denervation in Hypertension Treatment - 8 month(s) ago

    August 21, 2023 — The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement on Renal Denervation (RDN), emphasizing patient selection, optimal techniques, competence, training, and institutional recommendations. The statement was published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).    Despite advocacy for lifestyle interventions and the availability of medications to address hypertension (HTN), more than one half of individuals with high blood pressure do not achieve recommended treatment goals. RDN, a minimally invasive procedure targeting sympathetic nerves adjacent to the renal arteries, has shown promising results in reducing blood pressure.   Hypertension is a leading cause of death and disability globally, and the prevalence of uncontrolled HTN is on the rise. The impact of cost, side effects, and polypharmacy on quality-of-life often limit access and adherence to pharmacotherapy. Therapies targe

    Source: www.dicardiology.com
    Categories: Cardiologists, Latest Headlines
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      DAICeditor

      @DAICeditor @SCAI @MyJSCAI #SCAI has released a position statement on #RenalDenervation (#RDN), emphasizing patient selection, optimal techniques, competence, training, and institutional recommendations: https://t.co/B7qwkXiVcI

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