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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

Can the intermittent low-speed function of left ventricular assist device prevent aortic insufficiency?
In this study, the Jarvik 2000 device, which is programmed to reduce the pump speed each minute for 8  s, was chosen to examine this potential effect. Prospectively collected data of 85 heart transplant-eligible Jarvik 2000 recipients who met the study criteria (no pre-existing AI and aortic valve surgery) were retrospectively analyzed for the incidence, correlating factors, and clinical outcomes o f de novo AI. All data were provided by the Japanese Registry for Mechanically Assisted Circulatory Support. De novo AI occurred in 58 patients, 23 of whom developed at least moderate AI during a median support duration of 23.5...
Source: Journal of Artificial Organs - January 9, 2021 Category: Transplant Surgery Source Type: research

Impact of bridge-to-bridge strategies from paracorporeal to implantable left ventricular assist devices on the pre-heart transplant outcome: A single-center analysis of 134 cases.
CONCLUSIONS: The BTB strategy is useful in providing long-term survival in patients with acute critical diseases. However, the early mortality rate after conversion is higher in patients who underwent the BTB strategy. PMID: 33243529 [PubMed - as supplied by publisher]
Source: Journal of Cardiology - November 23, 2020 Category: Cardiology Authors: Nakajima Doi S, Seguchi O, Yamamoto M, Fujita T, Fukushima S, Mochizuki H, Iwasaki K, Kimura Y, Toda K, Kumai Y, Kuroda K, Watanabe T, Yanase M, Kobayashi J, Kimura T, Fukushima N Tags: J Cardiol Source Type: research

1 Ventricular assist devices: developments in asia and global outlook for the next 10 years
The advent of left ventricular assist systems to support patients with advanced-stage heart failure has been a 50 year odyssey, now available broadly to such patients.1 Engineering advances have ushered in an era of small, durable devices that can be fully implanted within the chest. Yet, haemocompatibility related adverse events, which emanate from the interaction between the device and the patient they support are manifest principally in increased stroke rates, de novo device thrombosis requiring replacement and in gastrointestinal bleeding (a peculiar adverse event resulting from the unnatural physiology of continuous f...
Source: Heart Asia - April 24, 2019 Category: Cardiology Authors: Mehra, M. R. Tags: Keynote Lecture Source Type: research

Comorbidities and Biomarkers Vary between United States and Japanese LVAD Patients
Left ventricular assist device (LVAD) outcomes differ between Japan and US. While GI bleeding is common in US and rare in Japan, stroke and driveline infections are more common in Japan than US. The aim of this study was to explore whether inflammatory and angiogenesis biomarkers can explain these differences.
Source: The Journal of Heart and Lung Transplantation - March 16, 2019 Category: Transplant Surgery Authors: T. Imamura, A. Nguyen, D. Nitta, T. Fujino, L. Holzhauser, D. Rodgers, S. Kalantari, B. Smith, J. Raikhelkar, N. Narang, B. Chung, I. Ebong, C. Juricek, P. Combs, D. Onsager, T. Song, T. Ota, V. Jeevanandam, G. Kim, G. Sayer, M. Ono, N. Uriel Tags: 1065 Source Type: research

HeartFlow wins Japanese reimbursement for FFRct analysis
HeartFlow said yesterday that it won reimbursement coverage from the Japanese Ministry of Health, Labor and Welfare for its HeartFlow FFRct fractional flow reserve analysis. The Redwood City, Calif.-based company said that it has already received approval from the Japanese Pharmaceuticals and Medical Devices Agency, and that reimbursement will go into effect beginning on December 1. “When a patient presents with symptoms suggesting CAD, we want to be able to quickly and effectively diagnose patients while reducing the need for unnecessary tests or invasive procedures. In clinical studies, we were able to see firstha...
Source: Mass Device - November 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Featured Imaging Software / IT HeartFlow Source Type: news