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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 Application to U.S. FDA for New Indication to Expand Use of XARELTO ® (rivaroxaban) in Patients with Peripheral Artery Disease
RARITAN, NJ, October 26, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with peripheral artery disease (PAD). If approved, this new indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients after recent lower-extremity revascularization, a c...
Source: Johnson and Johnson - October 26, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Landmark Phase 3 VOYAGER PAD Study of XARELTO ® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit using...
Source: Johnson and Johnson - March 28, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Challenge to the Intestinal Mucosa During Sepsis
Conclusion The impact of sepsis on the gut is manifold, e.g., sepsis mediated alteration of the gut-blood barrier and increase in the intestinal permeability, which may correlate with the phenomena of bacterial translocation and lymphatic activation (“toxic-lymph”). Systemic consequences of sepsis are widespread and concern to the coagulative system, the microbiome as well as enzymes, such as pancreatic proteases, MMPs and IAPs. Nevertheless, the therapeutic approaches for modulating the mucosal immune system are still rarely effective in daily routine. Recent published studies showing that treatment with ...
Source: Frontiers in Immunology - April 29, 2019 Category: Allergy & Immunology Source Type: research

Neurological Involvement in Primary Systemic Vasculitis
Conclusion Neurological involvement is a common complication of PSV (Table 1), and neurologists play an important role in the identification and diagnosis of PSV patients with otherwise unexplained neurological symptoms as their chief complaint. This article summarizes the neurological manifestations of PSV and hopes to improve neuroscientists' understanding of this broad range of diseases. TABLE 1 Table 1. Common CNS and PNS involvements of primary systemic vasculitis. Author Contributions SZ conceived the article and wrote the manuscript. DY and GT reviewed and edited the manuscript. All authors ...
Source: Frontiers in Neurology - April 25, 2019 Category: Neurology Source Type: research

Artificial Intelligence in Medicine: Hope or Hype?
The use of Artificial Intelligence (AI) is on the rise in the technology sector and has become a buzz-worthy topic in many corners of our digital world. The application of AI in the medical field holds great promise for improving patient health, but will doctors and patients feel comfortable using it? Young startups have begun leveraging this technology to prove better health outcomes, but there's still a lot to do before we'll see AI used pervasively in the clinic. Current Landscape To date, the sweet spot in healthcare AI has been pairing algorithms with structured exercises in reading patient data and medical images to...
Source: MDDI - January 3, 2018 Category: Medical Devices Authors: Brian Scogland Tags: Software Source Type: news

French Intensive Care Society, International congress - Réanimation 2016.
C, Sauneuf B, Verrier P, Pottier V, Orabona M, Samba D, Viquesnel G, Lermuzeaux M, Hazera P, Hanouz JL, Parienti JJ, Du Cheyron D, Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guérin C, Dellamonica J, Jaber S, Similowski T, Quenot JP, Binquet C, Vinsonneau C, Barbar SD, Vinault S, Deckert V, Lemaire S, Hssain AA, Bruyère R, Souweine B, Lagrost L, Adrie C, Jung B, Daurat A, De Jong A, Chanques G, Mahul M, Monnin M, Molinari N, Lheureux O, Trepo E, Hites M, Cotton F, Wolff F, Surin R, Créteur J, Vincent JL, Gustot T, Jacobs F, Taccone FS, Neuville M, Timsit JF, El-Hel...
Source: Australian Family Physician - May 31, 2016 Category: Primary Care Authors: Jaillette E, Girault C, Brunin G, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S, Valette X, Desmeulles I, Savary B, Masson R, Seguin A, Daubi Tags: Ann Intensive Care Source Type: research

Disrupting Today's Healthcare System
This week in San Diego, Singularity University is holding its Exponential Medicine Conference, a look at how technologists are redesigning and rebuilding today's broken healthcare system. Healthcare today is reactive, retrospective, bureaucratic and expensive. It's sick care, not healthcare. This blog is about why the $3 trillion healthcare system is broken and how we are going to fix it. First, the Bad News: Doctors spend $210 billion per year on procedures that aren’t based on patient need, but fear of liability. Americans spend, on average, $8,915 per person on healthcare – more than any other count...
Source: Healthy Living - The Huffington Post - November 9, 2015 Category: Consumer Health News Source Type: news

Lung transplant of extrahospitalary donor after cardiac death
The objective of this study is to describe the results of lung transplantation of after cardiac death program, specifically the section regarding lung extraction donation. Twenty potential lung donors were obtained during the study. Most patients were male (19 cases), with a mean age of 42 years (36.5-49.5 years). A total of 33 lungs were donated (18 right and 15 left lungs). Most extractions were multiorganic (19 cases). One liver, 19 kidneys, 2 pancreas, and 19 corneas were obtained from these donors; bone tissue was obtained from all donors. The transplantation was bipulmonary in 13 cases and unipulmonary in 7. Thirty d...
Source: The American Journal of Emergency Medicine - March 5, 2013 Category: Emergency Medicine Authors: Alonso A. Mateos Rodríguez, José Maria Navalpotro Pascual, Francisco del Río Gallegos Tags: Brief Reports Source Type: research