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 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
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Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Transplantation News Source Type: news
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Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
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Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: IDCases - Category: Infectious Diseases Source Type: research
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Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
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Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
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Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news
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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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