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Condition: Atrial Fibrillation
Management: Food and Drug Administration (FDA)

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Total 197 results found since Jan 2013.

Andexanet Alfa and its Clinical Application
Heart Int. 2020 Jun 19;14(1):20-23. doi: 10.17925/HI.2020.14.1.20. eCollection 2020.ABSTRACTFactor Xa (FXa) inhibitors are widely used for stroke prevention in patients with nonvalvular atrial fibrillation, and for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Compared with warfarin, individual FXa inhibitors are associated with a lower risk of major bleeding. Nevertheless, bleeding remains a feared complication of any anticoagulant therapy. Despite their demonstrated safety, implementation of FXa inhibitors in clinical practice may have been limited by the lack of a specific antidote. Rece...
Source: Heart International - October 24, 2022 Category: Cardiology Authors: Fauve A Noordergraaf Marco Alings Source Type: research

Biosense Webster Launches the OCTARAY ™ Mapping Catheter with TRUEref™ Technology
IRVINE, CA – September 6, 2022 – Biosense Webster, Inc., part of Johnson & Johnson MedTech[†], today announced the release of the OCTARAY™ Mapping Catheter with TRUEref™ Technology powered by the CARTO™ 3 Version 7 System. The OCTARAY™ Mapping Catheter was developed for the mapping of cardiac arrhythmias, including atrial fibrillation (AFib). The catheter has eight splines with improved electrode spacing options to provide shorter and more efficient mapping times than PENTARAYTM NAV ECO Mapping Catheter, which may shorten overall ablation procedure times.[2],[8],[‡] AFib is the most common type of cardi...
Source: Johnson and Johnson - September 6, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Performing Transcatheter Left Atrial Appendage Closure: Techniques and Challenges
The left atrial appendage (LAA) has been demonstrated to be the major source of thromboemboli in patients with atrial fibrillation (AF).1 The rationale of LAA closure is based on eliminating LAA continuity with the left atrium thereby reducing stroke risk. Indeed, left atrial appendage occlusion (LAAO) procedures play an important role in anticoagulation-intolerant patients at risk for AF-related stroke. Based on the PROTECT-AF2 and PREVAIL3 studies, the Food and Drug Administration (FDA) approved use of the Watchman (Boston Scientific, MA) device in 2015, with an updated generation of device subsequently ratified in 2020 ...
Source: Heart Rhythm - August 6, 2022 Category: Cardiology Authors: Ammar M. Killu, Mohamad A. Alkhouli Source Type: research

Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study
Based on autopsy studies, the left atrial appendage has been implicated as the cause of stroke in>90% of cases with nonvalvular atrial fibrillation. The AtriClip device (Atricure, West Chester, OH) is used for left atrial appendage exclusion at the time of median sternotomy or thoracoscopically (as a  stand-alone procedure or at the time of hybrid epicardial-endocardial ablation for atrial fibrillation).1–3 The real-world safety profile of AtriClip has not been evaluated, and we analyzed adverse events related to its use reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
Source: Heart Rhythm - April 28, 2022 Category: Cardiology Authors: Tahmeed Contractor, Rahul Bhardwaj, Ravi Mandapati, Kamal Kotak, Jalaj Garg Tags: Research Letter Source Type: research

Data from New VOYAGER PAD Analyses at ACC.22 Reinforce Benefit of XARELTO ® (rivaroxaban) Plus Aspirin in Patients with Peripheral Artery Disease (PAD) and Various Co-Morbid Conditions
RARITAN, N.J., April 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularization (LER), a procedure that restores blood flow to the legs. Data from the two analyses demonstrate the role that the XARELTO® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and ...
Source: Johnson and Johnson - April 1, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Procedural and Short-Term Follow-Up Outcomes of Amplatzer Amulet Occluder versus Watchman FLX Device: A Meta-Analysis
Left atrial appendage (LAA) occlusion provides effective protection against thromboembolic (TE) events in high-risk atrial fibrillation patients. Two percutaneous devices are currently available in the United States for stroke prophylaxis: the WatchmanTM device (Boston Scientific, USA) and the AmplatzerTM AmuletTM Left Atrial Appendage Occluder (Abbott, USA). The latter has recently received Food and Drug Administration approval as a result of the findings of the Amulet IDE randomized trial (1), which showed superiority for LAA occlusion (lower rates of leaks>5mm) based on a comparison between the second generation Amplatz...
Source: Heart Rhythm - February 11, 2022 Category: Cardiology Authors: Domenico G. Della Rocca, Michele Magnocavallo, Carola Gianni, Sanghamitra Mohanty, Veronica N. Natale, Amin Al-Ahmad, Carlo Lavalle, Rodney P. Horton, Luigi Di Biase, Andrea Natale Source Type: research

Can I use DOAC in a patient with renal disease?
Case A 76-year-old man is diagnosed with non-valvular atrial fibrillation. His comorbid conditions are hypertension, diabetes complicated by neuropathy, and chronic kidney disease stage 3. His current medications include metformin, lisinopril, gabapentin, and aspirin. His most recent laboratories showed a creatinine 1.8, creatinine clearance (CrCl) 35 mL/min, hemoglobin 11g/dL, and international normalized ratio 1.0. His congestive heart failure, hypertension, age, diabetes, stroke, vascular disease, and sex (CHADSVASc) score is 4. Which medication should we use to prevent stroke in this patient?  Brief overview of the is...
Source: The Hospitalist - February 3, 2022 Category: Hospital Management Authors: Ronda Whitaker Tags: Renal & Genitourinary Source Type: research

FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen to Present the Strength and Promise of its Hematologic Malignancies Portfolio and Pipeline at ASH 2021
RARITAN, N.J., November 4, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that more than 45 company-sponsored abstracts, including 11 oral presentations, plus more than 35 investigator-initiated studies will be featured at the American Society of Hematology (ASH) Annual Meeting and Exposition. ASH is taking place at the Georgia World Congress Center in Atlanta and virtually from December 11-14, 2021.“We are committed to advancing the science and treatment of hematologic malignancies and look forward to presenting the latest research from our robust portfolio and pipeline during ASH...
Source: Johnson and Johnson - November 5, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the U.S. F...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Off-label reduced-dose apixaban does not reduce hemorrhagic risk in Taiwanese patients with nonvalvular atrial fibrillation: A retrospective, observational study
East Asians are reportedly at high risk of anticoagulant-related bleeding; therefore, some physicians prefer to prescribe low-dose direct oral anticoagulants (DOACs). Little is known about the therapeutic effectiveness and safety of off-label reduced-dose apixaban in East Asians with nonvalvular atrial fibrillation (AF). We aimed to investigate the effectiveness and safety of off-label reduced-dose apixaban in Taiwanese patients with nonvalvular AF. This retrospective cohort study enrolled 1073 patients with nonvalvular AF who took apixaban between July 2014 and October 2018 from 4 medical centers in southern Taiwan. Th...
Source: Medicine - June 11, 2021 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research

Evaluation of Prescribing Practices and Outcomes Using Direct-Acting Oral Anticoagulants After Cardiac Surgery
Clin Ther. 2021 May 30:S0149-2918(21)00203-4. doi: 10.1016/j.clinthera.2021.04.009. Online ahead of print.ABSTRACTPURPOSE: Cardiac surgery patients frequently require anticoagulation. Warfarin remains the preferred agent, and a few trials have reported negative outcomes with the use of direct-acting oral anticoagulants (DOACs) in these patients. Therefore, limited literature exists that supports the dosing, safety, and efficacy of DOACs within the cardiac surgery population.METHODS: This single-center, retrospective analysis was conducted at a tertiary academic medical center. All data were extrapolated from electronic med...
Source: Clinical Therapeutics - June 3, 2021 Category: Drugs & Pharmacology Authors: Dareen M Kanaan Bryan M Cook Julie Kelly Rhynn Malloy Source Type: research