FDA Issues Final Guidances on Guidewires, Intravascular Catheters and Delivery Systems
October 11, 2019
FDA Issues Final Guidances on Guidewires, Intravascular Catheters and Delivery Systems
October 11, 2019 — The U.S. Food and Drug Administration (FDA) issued two final guidances for the performance testing…
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Medtronic Initiates Worldwide Pivotal Study of Extravascular Implantable Cardioverter Defibrillator
October 11, 2019
Medtronic Initiates Worldwide Pivotal Study of Extravascular Implantable Cardioverter Defibrillator
October 11, 2019 — Medtronic plc announced the start of a worldwide pivotal study evaluating its investigational…
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TCT 2019 Late-breaking Presentations in the main arena. The top interventional cardiology studies of 2019. #TCT #TCT19 #TCT2019
October 11, 2019
TCT 2019 Late-breaking Presentations
October 10, 2019 — Here are the Cardiovascular Research Foundation (CRF) 12 late-breaking trials and 16 late-breaking…
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Supraflex Drug-Eluting Stent Superior to Xience in Two-Year Target Vessel Failure
October 11, 2019
Supraflex Drug-Eluting Stent Superior to Xience in Two-Year Target Vessel Failure
October 11, 2019 — The ultra-thin Supraflex drug-eluting stent (DES) from SMT maintained numerically lower outcomes at…
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An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no statistically significant mortality increase. This was one of the first major reviews of trial data for patients who were treated with a paclitaxel coated device used in peripheral vessels following a meta analysis study of paclitaxel device trials published in December 2018 that showed a mortality safety signal. This was a major discussion during the FDA townhall meeting at the #TCT2019.
October 10, 2019
LEVANT Trial Data Shows Safety of Drug-Coated Balloon Shown
October 10, 2019 — An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no…
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BackBeat CNT is the flagship therapy of Orchestra BioMed Inc. It is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS).
October 10, 2019
MODERATO II Study: Cardiac Neuromodulation Significantly Reduces Systolic Blood Pressure
October 10. 2019 — Late-breaking results from its MODERATO II double-blind, randomized study of BackBeat Cardiac…
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Fujifilm Upgrades Next-Generation Synapse Cardiology PACS
October 10, 2019
Fujifilm Upgrades Next-Generation Synapse Cardiology PACS
October 9, 2019 – Fujifilm Medical Systems U.S.A. Inc. recently launched Synapse Cardiology PACS 5.6.1, the company’s…
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Canon Medical Launches Alphenix Encore Plus Program
October 09, 2019
Canon Medical Launches Alphenix Encore Plus Program
October 9, 2019 — In the complex and fast-paced world of healthcare, customers face the challenge of staying up-to-date…
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Acutus Medical and Innovative Health Collaborate to Increase Patient Access to Electrophysiology Care
October 09, 2019
Acutus Medical and Innovative Health Collaborate to Increase Patient Access to Electrophysiology Care
October 9, 2019 — Acutus Medical and Innovative Health announced a partnership that will offer advanced…
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FDA Clears Abbott's High Sensitivity Troponin-I Blood Test
October 09, 2019
FDA Clears Abbott's High Sensitivity Troponin-I Blood Test
October 9, 2019 — Abbott recently announced that its Architect Stat High Sensitivity Troponin-I blood test has received…
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FDA Grants Breakthrough Device Designation for Valiant Thoracoabdominal Aortic Aneurysm Stent Graft
October 09, 2019
FDA Grants Breakthrough Device Designation for Valiant Thoracoabdominal Aortic Aneurysm Stent Graft
October 9, 2019 — Medtronic plc announced it has received Breakthrough Device designation from the U.S. Food and Drug…
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Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed. These fragments could be left inside the patient’s bloodstream, and this or the attempts made to retrieve the fractured pieces, can cause other serious adverse health consequences such as continued blockage of blood vessels, injury to blood vessel walls, development of
October 09, 2019
Medtronic Recalls 6 French Sherpa NX Active Guide Catheters
October 9, 2019 — Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer…
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American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair
October 08, 2019
American College of Cardiology Names Douglas Drachman Next Annual Scientific Session Vice Chair
October 8, 2019 — Douglas Drachman, M.D., FACC, has been selected as the next vice chair of the American College of…
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PQ Bypass Granted IDE Approval to Start TORUS SFA Stent Graft Pivotal Study
October 08, 2019
PQ Bypass Granted IDE Approval to Start TORUS SFA Stent Graft Pivotal Study
October 8, 2019 — PQ Bypass Inc. announced it has received full approval of its investigational device exemption (IDE)…
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The life of Afib patient Glynn Crawford was saved three days after being prescribed a Zoll LifeVest wearable defibrillator by his cardiologist Barbara Williams, M.D., at University Hospitals Ahuja Medical CenterShe identified him as a high-risk for sudden cardiac arrest.
October 07, 2019
Sudden Cardiac Arrest Patient Walks to Ambulance Thanks to Wearable Defibrillator
October 7, 2019 — Glynn Crawford was hospitalized at University Hospitals Ahuja Medical Center in late June/early July…
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Heart MRI example. An example of a cardiac MRI exam showing perfusion defects in the heart muscle, amount of infarct and edema and a score for myocardial salvage which can help determine if revasularization will help restore heart function.
October 07, 2019
Cardiac MRI Delivers Accurate Diagnosis for Frontline Chest Pain Evaluation
October 7, 2019 – A recent study published in the New England Journal of Medicine supports the use of cardiac magnetic…
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A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography. Study Finds Sustained Benefit for TAVR vs. SAVR at One Year. #TCT2019 #TCT19
October 04, 2019
Study Finds Sustained Benefit for TAVR vs. SAVR at One Year
October 4, 2019 – A new analysis of the PARTNER 3 Trial data found a modest, but significant, improvement in one-year…
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The COAPT Economic Analysis sub-study found it is cost effective to treat heart failure patients who have severe secondary mitral regurgitation with MitraClip to reduce their MR symptoms. #TMVR #TCT2019 #TCT19
October 04, 2019
Transcatheter Mitral Valve Repair is Cost-Effective in Heart Failure Patients
October 4, 2019 – Results of a new economic analysis of the COAPT Trial data found that transcatheter mitral valve…
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RenalGuard Therapy was found to be superior to the POSEIDON method in preventing contrast-induced acute kidney injury (CI-AKI) for patients with kidney disease who undergo interventional cath lab procedures. Results of the 700 patient, randomized, investigator-driven REMEDIAL III Trial presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. #TCT19 #TCT2019
October 04, 2019
Contrast-Induced Kidney Injury Prevented With RenalGuard in REMEDIAL III Trial
October 4, 2019 – RenalGuard Therapy was found to be superior to the POSEIDON method in preventing contrast-induced…
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Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent Sapien 3 transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR. #TCT2019
October 03, 2019
Similar Outcomes for TAVR vs. SAVR in Intermediate Surgical Risk Patients
October 3, 2019 – Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and…
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