Myocardial Health News
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New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA
In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA) XARENO evaluated the impact of Xarelto in patients with NVAF and CKD, given that ...
By Bayer AG
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Elucid’s Next-Generation Plaque Analysis and FFRCT Technology to be Featured on 2022 AHA Scientific Sessions Program
BOSTON – November 4, 2022 – Elucid, Inc., a medical technology company providing physicians AI-powered imaging analysis software to characterize cardiovascular disease, has announced that the company’s technology will be featured on the program at the 2022 American Heart Association (AHA) Scientific Sessions, November 5-7, 2022 in Chicago. Elucid has developed FDA-cleared ...
By Elucid
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Alnylam Presents Additional Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy at Heart Failure Society of America Annual Meeting
– New Data Further Support Potential for Patisiran to be an Effective Treatment for Cardiomyopathy of ATTR Amyloidosis – – Data from Exploratory Endpoints, Including Cardiac Biomarkers and Imaging, Suggest Favorable Impact of Patisiran on Measures of Cardiac Stress, Injury, Structure, and Function at Month 12 – – Treatment with Patisiran Demonstrated Generally ...
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Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
By Bayer AG
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Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack involving up to 30,000 patients Bayer drives the development of its FXIa inhibitor, with the goal of offering a ...
By Bayer AG
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CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
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FAPI featured in accolades at annual Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting
Congratulations to investigators at Hannover School of Medicine and Heidelberg University Hospital for receiving the 2022 SNMMI Image of the Year Award and JNM Editors’ Choice Award for Overall Best Article in 2021, respectively. Both use FAPI as the primary indicator and further underscore its potential impact as a novel radiopharmaceutical. Each year, SNMMI chooses an image that best ...
By SOFIE
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One-stop Mitochondria-focused Testing Services Targeting to Preclinical Studies of Cardiac Diseases
New York, United States—June 28, 2022—Creative Biogene offers one-stop mitochondria-focused testing services for the evaluation of a variety of cardiac diseases associated with mitochondrial dysfunction, which can provide insights and potential treatments for mitochondrial disorders in the preclinical stages. With its ready-to-use models and assays for cardiac diseases, customers can accurately ...
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Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. The approval is based on data from the Phase III VOYAGER PAD trial. This study demonstrated a positive ...
By Bayer AG
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Shockwave IVL Coronary Studies Demonstrate Excellent PCI Outcomes in Both Women and Men at One Year
Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today new data confirming excellent one-year outcomes with coronary IVL in both women and men. The one-year results from the Disrupt CAD clinical program were presented at the 2022 Scientific Sessions of the Society for ...
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TecTraum Announces Completion of Multisite Clinical Trial Using pro2cool Device for the Treatment of Concussions
TecTraum Inc., dedicated to providing the world’s first point-of-care treatment for concussions, announced complete enrollment status for a clinical trial that began in fall of 2019 using its flagship technology, pro2cool. The pro2cool system is a novel, noninvasive hypothermic therapy device designed to reduce the severity of concussion symptoms and allow patients to return to their ...
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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to COVID-19
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive ...
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Miracor Medical starts 2nd randomized study, targeting expanded indications
Miracor Medical SA (Miracor Medical) today announced the first patient enrolled in the PICSO-AMI-V study to evaluate the benefits of PiCSO® (Pressure-controlled intermittent Coronary Sinus Occlusion) therapy as an adjunct to conventional primary percutaneous coronary intervention (PCI) for patients presenting with inferior ST-Elevation Myocardial Infarction (STEMI). The first patient ...
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BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS). This new CMS code to ...
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`Bilirubin` to eliminate inflammation... Vilix, the world`s first pharmaceutical drug
Bilirubin, which causes jaundice in humans, has been in the spotlight as an anti-inflammatory substance since the 1930s. The phenomenon that rheumatoid inflammation disappears when a patient with rheumatoid arthritis suffers from jaundice was discovered by Philip Hench, a professor at the Mayo Clinic in the United States, who was awarded the Nobel Prize in Physiology or Medicine. Attempts to drug ...
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BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announces that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial (ClinicalTrials.gov Identifier: NCT02438306), just ...
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Anteris reports successful interim results for the first-in-human trial for DurAVR
Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention). An average 86% improvement in mean ...
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AVEO Oncology Presents Three Posters for Tivozanib/Immunotherapy Combinations at the 2022 ASCO GI Cancers Symposium
First line cohort of the Phase 1b/2 DEDUCTIVE study demonstrates promising efficacy and tolerability of tivozanib plus durvalumab in first line HCC Two trials in progress posters presentations for the DEDUCTIVE HCC study and the recently initiated Phase 1b/2 IMMCO-1 study of tivozanib and atezolizumab in multiple immunologically cold tumors AVEO Oncology (Nasdaq: AVEO), a commercial stage, ...
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AVEO Oncology Highlights Recent Progress and 2022 Outlook
AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today highlighted its recent progress and outlook for 2022. “I am proud of the entire AVEO team this year, as we accomplished several key milestones in the face of what remains a challenging environment with the ongoing COVID-19 pandemic,” said Michael Bailey, President and Chief Executive ...
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Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), today announced first-in-human cases of pulsed field cryoablation (PFCA) for the treatment of atrial fibrillation (AF). The cases were performed at Medicover Hospital, Warsaw, Poland by Dr. Pawel Derejko, Head of the Department of Cardiology at Medicover and ...
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