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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

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

EdoxabaN Versus standard of care and theIr effectS on clinical outcomes in pAtients havinG undergonE Transcatheter Aortic Valve Implantation in Atrial Fibrillation—Rationale and design of the ENVISAGE-TAVI AF trial
Publication date: November 2018Source: American Heart Journal, Volume 205Author(s): Nicolas M. Van Mieghem, Martin Unverdorben, Marco Valgimigli, Roxana Mehran, Eric Boersma, Usman Baber, Christian Hengstenberg, Minggao Shi, Cathy Chen, Shigeru Saito, Roland Veltkamp, Pascal Vranckx, George D. DangasTranscatheter aortic valve implantation, also called transcatheter aortic valve replacement (TAVR), is the treatment of choice for patients with severe aortic stenosis and intermediate to high operative risk. A significant portion of TAVR patients have atrial fibrillation (AF) requiring chronic oral anticoagulation. In moderate...
Source: American Heart Journal - August 30, 2018 Category: Cardiology Source Type: research

Edoxaban vs. Vitamin K Antagonist for Atrial Fibrillation After Transcatheter Aortic Valve Replacement in Japanese Patients 　- A Subanalysis of the ENVISAGE-TAVI AF Trial
CONCLUSIONS: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.PMID:35965066 | DOI:10.1253/circj.CJ-22-0093
Source: Circulation Journal - August 14, 2022 Category: Cardiology Authors: Yusuke Watanabe Kentaro Hayashida Masanori Yamamoto Futoshi Yamanaka Kazumasa Yamasaki Toru Naganuma Yohei Ohno Masahiro Yamawaki Nobuyuki Morioka Kazuki Mizutani Norio Tada Hiroshi Ueno Hidetaka Nishina Masaki Izumo Yoshifumi Nakajima Kenji Ando Kensuke Source Type: research

Impact of mitral versus aortic bioprosthetic valve position  on thromboembolism and bleeding risk in patients with atrial fibrillation
CONCLUSIONS: In Japanese patients with AF and bioprosthetic valves, thromboembolic risk does not differ on the basis of valve position. Bleeding risk is higher in patients with MV bioprostheses, although valve position itself might not be an independent predictor for bleeding.PMID:34716054 | DOI:10.1016/j.jjcc.2021.10.002
Source: Journal of Cardiology - October 30, 2021 Category: Cardiology Authors: Yuki Obayashi Makoto Miyake Masashi Amano Takeshi Kitai Misa Takegami Kunihiro Nishimura Toshihiro Tamura Yutaka Furukawa Chisato Izumi Source Type: research