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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Edwards Lifesciences received European CE Mark approval for its SAPIEN 3 Ultra transcatheter aortic heart valve. Indicated for valve replacement in patients with severe, symptomatic aortic stenosis, the device is available in three sizes (20 mm,...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Source Type: blogs
As expected, Edwards Lifesciences has secured a CE mark for its Sapien 3 Ultra device, but the company won't be able to release the new transcatheter aortic valve replacement (TAVR) system in Germany due to a recent preliminary injunction from Boston Scientific. The CE mark allows Edwards to market the device in Europe for patients with severe, symptomatic aortic stenosis. "Edwards is disappointed in Boston Scientific's tactic to limit access of this new therapy," the company said in a press release. The Germany case involves a European patent  Boston Scientific acquired in 2017 when it bo...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail. The company said it will introduce the Sapien 3 Ultra in the rest of Euro...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Conclusions: Heart valve surgery is associated with cognitive decline over the 6 months after surgery, but outcomes beyond 6 months are unclear. These findings highlight the cognitive vulnerability of this population, especially older adults with aortic stenosis. The Study in Context: Study: 10-minute cognitive test MoCA helps predict long-term motor, cognitive and mortality outcomes after stroke Next: FDA-cleared mobile brain monitoring tools to detect cognitive impairment Should Hospitals Monitor, and Work to Maintain, Patients’ Cognitive Function? What are cognitive abilities and how to boost them? ? Dig...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Cognitive Neuroscience Health & Wellness cognitive monitoring cognitive outcomes cognitive-ability cognitive-baseline cognitive-decline heart surgery valve surgery Source Type: blogs
MONDAY, Oct. 22, 2018 (American Heart Association) -- When Tom Broussard came out of quadruple heart bypass surgery, the then-59-year-old was just glad to have avoided a heart attack. So he didn't give much thought to the heart valve that surgeons...
Source: Drugs.com - Daily MedNews - Category: General Medicine Source Type: news
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the T...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news
Edwards Lifesciences (NYSE:EW) said yesterday it launched a U.S.-based pivotal trial of its self-expanding Centera transcatheter aortic valve, exploring its use in treating severe symptomatic aortic stenosis in intermediate risk patients. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized delivery system in which the valve is pre-attached to the mechanism for quick preparation, the Edwards said. The Irvine, Calif.-based company said it hopes to enroll approximately 1,000 patients in the trial, which will include a bicuspid registry. The endpoin...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news
ConclusionsECMO can be used as a bridge to heart valve or septal defect surgery in severely decompensated patients. Through recovery of end-organ function, ECMO may allow surgical correction of structural heart disease in patients considered inoperable or convert a salvage situation to an elective operation.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
CONCLUSIONS: ECMO can be used as a bridge to heart valve or septal defect surgery in severely decompensated patients. Through recovery of end-organ function, ECMO may allow surgical correction of structural heart disease in patients considered inoperable or convert a salvage situation to an elective operation. PMID: 30236527 [PubMed - as supplied by publisher]
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Ann Thorac Surg Source Type: research
MitraClip® Implantation Under Cerebral Protection: A Case Report. J Heart Valve Dis. 2017 Nov;26(6):728-730 Authors: Pohl J, Luedike P, Alexander Jánosi R, Rassaf T Abstract MitraClip® implantation is commonly used in patients with severe mitral regurgitation (MR) and who are at high risk for surgical mitral valve repair. The occurrence of stroke or transient ischemic attack is a potential complication in patients undergoing MitraClip implantation, and incidences of up to 2.6% have been reported. Herein is reported the case of an 84-year-old woman with severe MR and a thin filamentous st...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
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