Cardiovalve Reaches 2 Milestones for its Tricuspid Valve Replacement System

Cardiovalve has a pair of milestones that could help catapult the company into the forefront of the tricuspid valve market. The Or Yehuda, Israel-based company received FDA approval for an early feasibility study of the transcatheter tricuspid valve replacement system and Breakthrough Device Designation for the technology. The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation, with evaluations at 30 days and periodically up to five years. The study will be conducted in collaboration with five leading US hospitals. In a release Cardiovalve’s CEO Amir Gross, CEO said, "We are excited about the FDA’s recognition of the potential clinical benefit of the Transcatheter Tricuspid Valve Replacement System. We now have clinical data two years out that our implant is functioning as expected and the patient is improved clinically. FDA’s ‘breakthrough’ designation validates and reaffirms our commitment to improving and extending the lives of millions of patients suffering from heart valve disease across the world." Cardiovalve isn’t the only company that has made significant strides in the tricuspid valve space. In September of last year, Abbott Laboratories had a significant milestone in space by nabbing an IDE for the TriClip from FDA. Abbott's IDE study is set to enro...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Cardiovascular Source Type: news

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(American College of Cardiology) Patients undergoing transcatheter aortic valve replacement (TAVR) fared equally well compared with those undergoing open heart valve replacement surgery in terms of the combined risk of death, stroke or rehospitalization at two years, the primary endpoint of the PARTNER 3 trial being presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
(American College of Cardiology) Patients who underwent transcatheter aortic valve replacement (TAVR) did not have a higher rate of death at one year compared with those who had their heart valve replaced via open-heart surgery, according to research presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
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...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
Abstract Ischemic heart disease is a predominant cause of death worldwide. The loss or death of cardiomyocytes due to restricted blood flow often results in a cardiac injury. These injured cardiomyocytes are replaced by myofibroblasts that preserve structural integrity. However, the depleted cardiomyocytes lead to cardiac dysfunction such as pathological cardiac dilation, reduced cardiac contraction and fibrosis. Repair and regeneration of myocardium are the best possible therapy for the end-stage heart failure patients because the current therapies that can help restore the lost cardiomyocytes are limited to hear...
Source: Current Pharmaceutical Design - Category: Drugs & Pharmacology Authors: Tags: Curr Pharm Des Source Type: research
ConclusionIn children, the results of mitral valve replacement were found to be inferior to those of mitral valve repair. The reoperation rates are similar in patients undergoing initial repair or replacement, which favors repair as an option. In developing world, rheumatic mitral valve disease is more prevalent where adequate facilities for monitoring of prosthetic valve function and management of anticoagulation therapy are not easily available. Valve repair therefore should be the primary goal.
Source: Indian Journal of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Conclusion: The most frequent isolated valve surgery in Brazil is the aortic valve replacement by conventional open access and the rheumatic disease is still the main etiology for valve surgery. The BYPASS Registry has a fundamental role to provide information on the profile of patients with valve heart disease in our country in order to delineate adequate strategies for health promotion and resource allocation for cardiac surgery.
Source: Revista Brasileira de Cirurgia Cardiovascular - Category: Cardiovascular & Thoracic Surgery Source Type: research
AbstractFunctional tricuspid regurgitation (FTR) is defined as abnormal systolic tricuspid leakage with normal valve structures, and its prognostic role and management in patients with left-heart valve disease is well known. Due to paucity of data on FTR in patients with ischemic heart disease, the aim of our prospective study was to compare the prognostic effect of FTR between patients with moderate FTR and those with less-than-moderate FTR undergoing isolated coronary artery bypass graft (CABG) surgery. This prospective cohort study included all the patients who were candidate for isolated CABG and were referred for preo...
Source: The International Journal of Cardiovascular Imaging - Category: Radiology Source Type: research
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to ...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
ConclusionsFollowing heart valve surgery, the risk of recurrent IE was significantly higher than the risk of first-time IE.Graphic abstract
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
CONCLUSIONS: Bleeding and thromboembolic complications were common in MHV prosthesis patients in this study. Long duration of anticoagulation, albeit sub-optimal control, was a risk factor for bleeding and thromboembolic complications in these patients. Therefore, long-term efforts are necessary to address these complications and possibly improve the quality of life of these patients. PMID: 32181794 [PubMed - as supplied by publisher]
Source: Cardiovascular Journal of Africa - Category: Cardiology Authors: Tags: Cardiovasc J Afr Source Type: research
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