Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial

Abbott Laboratories’ latest pivotal trial will have the company taking a deeper dive into the treatment of what has been dubbed by some as the “forgotten valve.” The Abbott Park, IL-based has launched an IDE study of the TriClip, a transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). The TRILUMINATE Pivotal trial will evaluate a catheter-based, non-surgical treatment for patients with severe TR – a condition in which the valve doesn't close properly, allowing blood to flow backward into the heart, which forces the heart to work harder. Abbott's IDE study is set to enroll 700 patients in centers in the U.S., Canada, and Europe. Patients in the trial will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years. The study will also have a single arm for the treatment of subjects with more complex tricuspid valve disease. TriClip was also accepted for national reimbursement consideration through a process known as "Parallel Review" by FDA and the Centers for Medicare and Medicaid Services. There is data from an 85-patient trial with sites in the U.S. and Europe that show TriClip’s effectiveness. Results from this trial were revealed during EuroPCR 2019 in May. The results show that after 30 days, 86.6% of patients who received the TriClip device saw a reduction in TR severity of at...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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AbstractPurpose of reviewFunctional mitral regurgitation (MR) in setting of cardiomyopathy causes significant morbidity and worsened survival. Surgical therapies have failed to demonstrate significant overall benefit for functional MR. More recently, major trials utilizing transcatheter therapies for functional MR have been completed and offer new avenues for intervention. This review evaluates and compares 2 major recent trials designed to test the benefit of edge-to-edge repair using the MitraClip system for severe functional MR.Recent findingsThe Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy f...
Source: Current Treatment Options in Cardiovascular Medicine - Category: Cardiology Source Type: research
This study demonstrates for the first time that senescent cells secrete functional LTs, significantly contributing to the LTs pool known to cause or exacerbate idiopathic pulmonary fibrosis. Against Senolytics https://www.fightaging.org/archives/2019/11/against-senolytics/ There is no consensus in science that is so strong as to have no heretics. So here we have an interview with a naysayer on the matter of senolytic treatments, who argues that the loss of senescent cells in aged tissues will cause more harm to long-term health than the damage they will do by remaining. To be clear, I think this to be a ...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Dogs are an interesting species when it comes to the study of aging. Firstly they are much closer to human metabolism and cellular biochemistry than mice, and secondly selective breeding has generated lineages with a very wide range of sizes and life spans. Thirdly, they occupy a good compromise position in the range of life spans, study cost, and similarity to humans. Mice live short lives, so studies are rapid and comparatively cheap, but there are sizable, important differences between mouse and human biochemistry. Humans live so long that most studies of aging are simply out of the question. Even in non-human primates ...
Source: Fight Aging! - Category: Research Authors: Tags: Medicine, Biotech, Research Source Type: blogs
A stronger and more experienced Ancora Heart entered into the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation this past week. The private company – which is poised to take on medtech giants Abbott Laboratories and Edwards Lifesciences in the functional mitral regurgitation (FMR) space, presented even more data than it did last year at TCT. “There’s a big presence for us this year [at TCT] with three different presentations,” Jeff Closs, president and CEO of Ancora Heart, to...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news
ConclusionsAt 5-year follow-up after Mitraclip nearly half of patients died and almost two-third died or were admitted for HF. MR recurrence, ischaemic etiology, high comorbidity burden (i.e. EuroSCORE II> 5%, COPD), and advanced cardiomyopathy (i.e. LVEF1.5 mg/dL) significantly increase the relative risk of 5-year clinical events.
Source: American Heart Journal - Category: Cardiology Source Type: research
​BY JENNIFER TUONG; IVAN KHARCHENKO; JEAN LUC AGARD; &AHMED RAZIUDDIN, MDA 65-year-old man who had HIV well-controlled with highly active antiretroviral therapy, hypertension, sciatica, and restless leg syndrome presented to the emergency department with left leg pain. He also had had chemotherapy and radiation for anal cancer. The patient said the pain had started 45 minutes earlier when he was sitting on the toilet.He described the pain as sore in quality and 10/10 on the pain scale. He reported that it had started in his lower back and radiated to his left leg. He said he had had no trauma or weakness to the regio...
Source: The Case Files - Category: Emergency Medicine Tags: Blog Posts Source Type: research
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
One of the many possible paths towards developing a new medical technology is to first focus on veterinary use. It is considerably less costly in time and resources to develop a therapy for dogs, say, than it is to develop a therapy for humans. Later, given robust success in veterinary medicine, the therapy can be brought into the sphere of human medicine. This is the approach taken by Rejuvenate Bio for their class of regenerative gene therapies. As noted here, the company is moving forward to trials in companion animals, starting later this year. Back in 2015, the Church lab at Harvard began testing a variety of...
Source: Fight Aging! - Category: Research Authors: Tags: Daily News Source Type: blogs
Conclusion: We conclude that elevated KB levels were beneficial for mitochondrial repair in the aging heart. However, an impaired MFN2-DRP1-mediated fusion-fission process in HF reduced this benefit, as well as Parkin degradation and mitophagic signaling cascade. Introduction The incidence of cardiovascular disease, including heart failure (HF), has increased steadily in the United States as the general population has aged (Roger et al., 2004; Savarese and Lund, 2017). Mitochondria are essential for energy generation to maintain cardiac contraction during each heartbeat. However, mitochondrial function decli...
Source: Frontiers in Physiology - Category: Physiology Source Type: research
Abstract This paper presents a case study of a 30-year-old male patient with dyspnea on exertion had echocardiographic diagnosis of aortic subvalvar stenosis. Discrete mitral regurgitation and aortic valve dysplasia with mild to moderate insufficiency and hypertrophic cardiomyopathy were also noted. During surgery, a rare condition was identified: presence of papillary muscle anomaly associated with the subaortic membrane as a cause of obstruction of the left ventricular outflow tract. With the resection of these structures and a mitral valve annuloplasty, the patient evolved with a significant improvement of clinical cond...
Source: Revista Brasileira de Cirurgia Cardiovascular - Category: Cardiovascular & Thoracic Surgery Source Type: research
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