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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

A Comparison of Three Different Bioinformatics Analyses of the 16S –23S rRNA Encoding Region for Bacterial Identification
Conclusion The higher resolution at the species level identification provided by 16S–23S rRNA encoding region NGS makes its use in routine diagnostic microbiology potentially attractive. Particularly, data analysis is one of the most important steps of a diagnostic workflow, which requires an optimal pipeline for the interpretation of the sequencing data in a short time. This study demonstrates that de novo assembly and subsequent BLASTN analysis using an in-house developed database compared to OTU clustering and mapping approaches is the most accurate and fastest approach for identification of bacterial pathogens....
Source: Frontiers in Microbiology - April 15, 2019 Category: Microbiology Source Type: research

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Apixaban for stroke prevention in a patient with a mechanical heart valve.
PMID: 30418836 [PubMed - in process]
Source: British Journal of Hospital Medicine - November 2, 2018 Category: Internal Medicine Authors: Shukla P, Ashraf I, Aghoram P Tags: Br J Hosp Med (Lond) Source Type: research

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice
ConclusionsNOACs are increasingly used in German nursing homes, both for initial anticoagulation but also in VKA pre‐treated patients. Switching from VKA to NOAC was substantially influenced by aspects such as intended higher effectiveness and safety but probably also practicability due to less blood monitoring.
Source: British Journal of Clinical Pharmacology - January 11, 2018 Category: Drugs & Pharmacology Authors: Kathrin Jobski, Falk Hoffmann, Stefan Herget ‐Rosenthal, Michael Dörks Tags: PHARMACOEPIDEMIOLOGY Source Type: research

Oral Anticoagulants in German nursing home residents – Drug use patterns and predictors for treatment choice
ConclusionsNOACs are increasingly used in German nursing homes, both for initial anticoagulation but also in VKA pre‐treated patients. Switching from VKA to NOAC was substantially influenced by aspects such as intended higher effectiveness and safety but probably also practicability due to less blood monitoring.
Source: British Journal of Clinical Pharmacology - November 1, 2017 Category: Drugs & Pharmacology Authors: Kathrin Jobski, Falk Hoffmann, Stefan Herget ‐Rosenthal, Michael Dörks Tags: PHARMACOEPIDEMIOLOGY Source Type: research

Pre-treatment clinical assessment in head and neck cancer: United Kingdom National Multidisciplinary Guidelines.
Authors: Robson A, Sturman J, Williamson P, Conboy P, Penney S, Wood H Abstract This is the official guideline endorsed by the specialty associations involved in the care of head and neck cancer patients in the UK. This paper provides recommendations on the pre-treatment clinical assessment of patients presenting with head and neck cancer. Recommendations • Comorbidity data should be collected as it is important in the analysis of survival, quality of life and functional outcomes after treatment as well as for comparing results of different treatment regimens and different centres. (R) • Patients with hypertens...
Source: Journal of Laryngology and Otology - November 15, 2016 Category: ENT & OMF Tags: J Laryngol Otol Source Type: research