SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver

SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device. In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction. SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebrovascular accidents. “None of the primary causes of death in the C2 Cohort was the result of a device malfunction. The Device Malfunction Adverse Event (AE) analysis revealed that the reliability of the C2 Driver is consistent with the reliability of the CSS Console as demonstrated by non-statistically significant rates of occurrence per 100 patient months of Device Malfunction AEs at three months (CSS: 1.8 vs. C2: 3.8) and six months (CSS: 1.8 vs. C2: 3.3) post-implant,” the company wrote in its response letter. SynCardia said that data from the post-approval study also showed that most cerebrovascular accidents occurred within the first three months of TAH support, which the company believes “is due to patient pre-implant condition” and that patient duration on the C2 Driver does not result in a higher rate of adverse events...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news

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This study provides strong evidence that following a healthy lifestyle can substantially extend the years a person lives disease-free." Commentary on Recent Evidence for Cognitive Decline to Precede Amyloid Aggregation in Alzheimer's Disease https://www.fightaging.org/archives/2020/01/commentary-on-recent-evidence-for-cognitive-decline-to-precede-amyloid-aggregation-in-alzheimers-disease/ I can't say that I think the data presented in the research noted here merits quite the degree of the attention that it has been given in the popular science press. It is interesting, but not compelling if its role...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Siegfried Richtsteig has been waiting in hospital for more than 130 days for a heart that would allow him to do the things he enjoyed most, like playing with his grandchildren, before a stroke damaged the organ beyond repair.Reuters Health Information
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Transplantation News Source Type: news
CONCLUSION: A VAD system can be implanted as an alternative to cardiac transplan- tation or as a bridging treatment until the patient can be listed for transplantation and receive the transplant. Because of the organ s , only a minority of VAD patients ever receive a transplant. PMID: 31931951 [PubMed - in process]
Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
(University of Bern) People with mechanical heart valves need blood thinners on a daily basis, because they have a higher risk of blood clots and stroke. Researchers at the ARTORG Center of the University of Bern, Switzerland, now identified the root cause of blood turbulence leading to clotting. Design optimization could greatly reduce the risk of clotting and enable these patients to live without life-long medication.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
In this study, we investigated the link between AF and senescence markers through the assessment of protein expression in the tissue lysates of human appendages from patients in AF, including paroxysmal (PAF) or permanent AF (PmAF), and in sinus rhythm (SR). The major findings of the study indicated that the progression of AF is strongly related to the human atrial senescence burden as determined by p53 and p16 expression. The stepwise increase of senescence (p53, p16), prothrombotic (TF), and proremodeling (MMP-9) markers observed in the right atrial appendages of patients in SR, PAF, and PmAF points toward multiple inter...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Publication date: Available online 9 January 2020Source: IDCasesAuthor(s): Abhimanyu Aggarwal,, Karen Hogan,, Armando Paez,AbstractAspergillus endocarditis is a rare cause of culture-negative fungal endocarditis, after Candida endocarditis. Typical risk factors include intravenous drug use, immunosuppression, prior cardiac surgery or presence of prosthetic heart valves, hematopoietic stem cell or solid organ transplantation. Common presentations include signs and symptoms consistent with endocarditis but with negative bacterial blood cultures. Here, we present a case report of a 49-year-old male without known risk factors ...
Source: IDCases - Category: Infectious Diseases Source Type: research
(American Heart Association) One-year survival was 90% for adults with severe heart failure who received a heart transplant from a donor with hepatitis C, which was nearly identical to those who received a heart from donors who did not have hepatitis C (91%). Rates of organ rejection, stroke and kidney dialysis were similar between the two groups. More research is needed to assess longer-term results, however, increased use of hearts from donors with hepatitis C could help overcome the national shortage of donor organs.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
In this study, by adenovirus-mediated delivery and inducible transgenic mouse models, we demonstrate the proliferation of both HCs and SCs by combined Notch1 and Myc activation in in vitro and in vivo inner ear adult mouse models. These proliferating mature SCs and HCs maintain their respective identities. Moreover, when presented with HC induction signals, reprogrammed adult SCs transdifferentiate into HC-like cells both in vitro and in vivo. Finally, our data suggest that regenerated HC-like cells likely possess functional transduction channels and are able to form connections with adult auditory neurons. Epige...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things." Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things: "A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming ...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news
By HANS DUVEFELT, MD Medical researchers and their groupies – early adopters, thoughtleaders, those easily influenced or whatever you want to call them – never seem to learn that when you try to outsmart Mother Nature or Our Heavenly Father, whichever appeals more to your world view, you usually get your hand slapped. When I was a resident (1981-1984), I got penalized if I didn’t offer postmenopausal women estrogen-progesterone replacement therapy because it seemed obvious that if women with endogenous estrogen didn’t get many strokes or heart attacks and women without estrogen did, all we nee...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Medical Practice Physicians Primary Care Hans Duvefelt Source Type: blogs
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