Abiomed touts expanded Impella heart pump indication, launches Women ’s Initiative

Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy. The approval follows a previous FDA indication the Danvers, Mass.-based company won in April 2016 that cleared the device for treating acute myocardial infarction cardiogenic shock and post-cardiotomy cardiogenic shock. Abiomed touts its Impella heart pumps as the only percutaneous temporary ventricular support devices with FDA approval for cardiogenic shock in the setting of cardiomyopathy, according to a press release. The company also announced a new Women’s Initiative, which will focus on heart recovery education and awareness and comes in conjunction with the new approval covering permpartum and postpartum cardiomyopathy. “The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy. Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery, for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients,” Dr. Cindy Grines of Hofstra/Northwell Health said in a prepared statement. “With our expanded indication, we can invest in education and aware...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Cardiovascular Catheters Food & Drug Administration (FDA) Regulatory/Compliance Abiomed Source Type: news

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Abstract A number of devices can now provide mechanical circulatory support (MCS) to patients with acute cardiogenic shock (CS) and chronic end-stage heart failure (HF). Women differ from men in pathophysiology and natural history of CS and HF, and are usually sicker at admission. Current evidence suggests that women benefit as much as men, if not more, from both temporary and durable MCS for appropriate indications. Yet, women have been under-represented in clinical trials of MCS devices. Limited evidence suggests that women benefit more from temporary MCS in CS associated with acute myocardial infarction. Howeve...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
AbstractAimsThe aim of this study was to determine the incidence, predictors, and short ‐term and long‐term outcomes associated with in‐hospital sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) collectively termed ventricular arrhythmia (VA) in the heart failure (HF) patients.Methods and resultsThe HEart function Assessment Registry Trial in Saudi Arabia (HEARTS registry) is a prospective national registry of patients with chronic HF from18 tertiary care hospitals across Saudi Arabia. Diagnosis of HF was in accordance with American Heart Association/European Society of Cardiology definition cr...
Source: ESC Heart Failure - Category: Cardiology Authors: Tags: Original Research Article Source Type: research
ConclusionsThe incidence of arrhythmia and shock in patients with TTC does not correlate with the extent of myocardium involvement. The presence of LBBB in such cases can help recognize at-risk populations, and with timely intervention, life-threatening complications can be avoided. Despite limitations of the dataset and inability to establish causality, prospective studies with longer follow-up are warranted.
Source: Cardiology and Therapy - Category: Cardiology Source Type: research
rez O Abstract BACKGROUND: Despite advances in intensive care medicine, management of cardiogenic shock (CS) remains difficult and imperfect, with high mortality rates, regardless of aetiology. Predictive data regarding long-term mortality rates in patients presenting CS are sparse. AIM: To describe prognostic factors for long-term mortality in CS of different aetiologies. METHODS: Two hundred and seventy-five patients with CS admitted to our tertiary centre between January 2013 and December 2014 were reviewed retrospectively. Mortality was recorded in December 2016. A Cox proportional-hazards model was ...
Source: Archives of Cardiovascular Diseases - Category: Cardiology Authors: Tags: Arch Cardiovasc Dis Source Type: research
This study sought to evaluate the clinical characteristics and outcomes of Takotusbo cardiomyopathy cardiogenic shock (TC-CS) in comparison to those of acute myocardial infarction cardiogenic shock (AMI-CS) among patients hospitalized in the United States. We additionally sought to compare the incidence of multiorgan failure and use of supportive therapies as well as the trends over time, given the increasing awareness and diagnosis of TC.BackgroundCS is a major complication of TC; however, there are limited data, especially as to how TC-CS compares to AMI-CS.MethodsThe National Inpatient Sample Database was used to identi...
Source: JACC: Heart Failure - Category: Cardiology Source Type: research
CONCLUSIONS Mitochondrial damage is a potentially important mechanism and early indicator for 5-FU-induced cardiovascular disease. PMID: 30240386 [PubMed - in process]
Source: Medical Science Monitor - Category: Research Tags: Med Sci Monit Source Type: research
CONCLUSION: Prolonged veno-arterial extracorporeal life support for cardiac failure is feasible with low technical complication rates. Survival rates are acceptable, yet inferior to short-term support. We observed a shift from initial shock-related complications to infections during prolonged support. Since recovery and thus weaning is rather unlikely after a prolonged need for extracorporeal life support, this form of support should be limited to centers offering the full spectrum of interdisciplinary cardiac care including ventricular assist device implantation and transplantation. PMID: 29896993 [PubMed - as supplied by publisher]
Source: The International Journal of Artificial Organs - Category: Transplant Surgery Authors: Tags: Int J Artif Organs Source Type: research
Conclusion Despite hemodynamic improvements with IABP support, patients with non-AMI cardiogenic shock still suffer poor outcomes. Patients with ischemic cardiomyopathy and low LVPCI fared significantly worse. These patients may warrant closer observation or earlier consideration of more advanced hemodynamic support.
Source: American Heart Journal - Category: Cardiology Source Type: research
ConclusionLevitronix Centrimag ® remains a versatile device with potential in an acute setting. Early aggressive treatment and a younger patient population may well justify its use.
Source: Indian Journal of Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Conclusions In this first human test, mitral loop cerclage annuloplasty was successful in 4 of 5 attempts, caused reverse remodeling (reduction in secondary mitral regurgitation and heart chamber volumes), and suggested electrical remodeling (reversion of atrial fibrillation). Further evaluation is warranted.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - Category: Cardiology Authors: Tags: Structural Source Type: research
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