Boston Scientific touts Acurate Neo2 CE Mark study

Boston Scientific (NYSE:BSX) yesterday touted results from a European study of the Acurate Neo2 replacement heart valve it acquired along with Symetis last year. Thirty-day results from a 120-patient trial backing a bid for CE Mark approval for the transcatheter aortic valve replacement, acquired for $435 million in May 2017, were presented at the annual PCR London Valves conference, Marlborough, Mass.-based Boston Scientific said. Patients treated in the single-arm study showed a 97% rate of mild or less-than-mild paravalvular leakage and a procedural success rate of 97.5%, the company said. All-cause mortality (the primary safety endpoint) was 3.3% and the rate of disabling stroke was 1.7%. Of the 3% with more than mild PVL, no cases showed greater-than-moderate leakage, Boston said. Mean pressure gradients and effective orifice areas were 7.9 +/- 3.2mmHg and 1.7 cm2, respectively. “We are very pleased with the initial performance of the Acurate Neo2 valve system and the low paravalvular regurgitation rates, lower than previously reported with Acurate neo, which can be attributed to the new advanced sealing technology,” global chief medical officer Dr. Ian Meredith said in prepared remarks. “Boston Scientific is committed to gathering clinical evidence that advances transcatheter heart valve therapies and expands our reach in patient care, especially in addressing unique patient pathologies and anatomies.” The post Bosto...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news

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There has been a flurry of news recently about a procedure called trans-catheter aortic valve replacement (TAVR) for the treatment of the common heart condition aortic stenosis (AS). You may even know people who have had this procedure performed. What exactly is TAVR? And what’s all the excitement about? What is aortic stenosis? First, it’s important to understand the condition that TAVR is designed to treat, aortic stenosis. The aortic valve is the last structure of the heart through which blood passes before entering the aorta and circulating throughout the body. The aortic valve has three flaps, called leafl...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Health Heart Health Surgery Source Type: blogs
Conclusions: Embolism associated with asymptomatic carotid stenosis shows circadian variation with highest rates 4–6 h before midday. This corresponds with peak circadian incidence of stroke and other vascular complications. These and ASED Study results show that monitoring frequency, duration, and time of day are important in ES detection. Introduction Transcranial Doppler (TCD) detected microembolism in the ipsilateral middle cerebral artery (MCA) may help stratify the risk of stroke and other arterial disease complications in persons with advanced (≥60%) asymptomatic carotid stenosis. If so, this techniqu...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Abstract Valvular heart diseases are one of the most frequent causes for heart failure. Degenerative diseases of the aortic and mitral valve as well as a dysfunctional tricuspid valve disease result in a worse clinical outcome if severe. Minimal-invasive, surgical and/or catheter-based structural heart disease (SHD) interventions have recently seen a dramatic increase. Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is a disruptive technology, and next generation devices and careful patient selection will minimize limitations of TAVI such as paravalvular leak, conductance disturbance...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
ConclusionPreoperative ECG Strain was associated with higher risk of ME onset after TAVR for severe AS.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine. Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between Se...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
UCLA researchers have identified for the first time the origin of an immune cell that plays a critical role in the formation of healthy heart valves. The findings could pave the way for new treatments for heart valve disorders, which can be caused by congenital defects, aging or disease.Their study, led by Dr. Atsushi “Austin” Nakano, a UCLA associate professor of molecular, cell and developmental biology and member of theEli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, was published in the journal Developmental Cell.Building on previous research by Nakano, which showed that ...
Source: UCLA Newsroom: Health Sciences - Category: Universities & Medical Training Source Type: news
CONCLUSION: The evidence base for anticoagulation over a time frame of several years is inadequate at present, and direct comparative data for the different types of NOAC are not yet available. PMID: 30602410 [PubMed - in process]
Source: Deutsches Arzteblatt International - Category: General Medicine Tags: Dtsch Arztebl Int Source Type: research
Mechanical circulatory support options remain limited for pediatric patients, especially neonates. The only U.S. Food and Drug Administration-approved pediatric device remains the Berlin Heart EXCOR, which unfortunately carries with it a 20–30% risk of neurologic complications, such as strokes. We demonstrate a new technique of direct echocardiographic color-Doppler imaging of the Berlin Heart valves to detect valve regurgitation. Increases in valve regurgitation could indicate issues with pump-valve thrombosis or increased afterload leading to valve insufficiency. Early recognition of valve thrombosis or insufficien...
Source: ASAIO Journal - Category: Medical Devices Tags: Case Reports Source Type: research
Publication date: January 2019Source: Archives of Cardiovascular Diseases Supplements, Volume 11, Issue 1Author(s): A. Bisson, A. Bodin, N. Clementy, A. Bernard, B. Pierre, D. Babuty, G.Y.H. Lip, L. FauchierBackgroundIn 2017, a new definition of ‘valvular/non-valvular’ atrial fibrillation (AF) has been proposed.PurposeWe compared thromboembolic (TE) and bleeding risks in patients with AF according to the new ‘Evaluated Heartvalves, Rheumatic or Artificial’ (EHRA) valve classification.MethodsPatients were divided into 3 categories: (i) EHRA type 1 corresponds to the previous ‘valvular’ AF...
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
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