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Can Patent Foramen Ovales Cause Problems?
Discussion During fetal development, the heart primum and secundum septa grow and overlap leaving a small but important channel between the two atria. The foramen ovale is a flap valve moving blood from the right atrium into the left atrium directly and bypassing the high pressure pulmonary system. After birth and breathing air, the neonate’s lungs open up and the pulmonary vascular resistance decreases. The left atrium now has a relatively higher pressure than the right atria, and therefore pressure on the flap valve closes the foramen ovale. Usually within 6-12 months, the fusion of the primum and secundum of the f...
Source: PediatricEducation.org - July 24, 2023 Category: Pediatrics Authors: Pediatric Education Tags: Uncategorized Source Type: news

Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart  said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news

Valve-in-valve transcatheter aortic valve implantation after failed surgically implanted aortic bioprosthesis versus native transcatheter aortic valve implantation for aortic stenosis: Data from a nationwide analysis.
CONCLUSION: We observed that valve-in-valve TAVI was associated with good short- and long-term outcomes. No significant differences were observed compared with native valve TAVI regarding clinical follow-up. PMID: 32532695 [PubMed - as supplied by publisher]
Source: Archives of Cardiovascular Diseases - June 8, 2020 Category: Cardiology Authors: Deharo P, Bisson A, Herbert J, Lacour T, Saint Etienne C, Jaussaud N, Theron A, Collart F, Bourguignon T, Cuisset T, Fauchier L Tags: Arch Cardiovasc Dis Source Type: research

Five ‐year outcomes of rapid‐deployment aortic valve replacement with the Edwards Intuity valve
ConclusionThe 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.
Source: Journal of Cardiac Surgery - May 26, 2021 Category: Cardiovascular & Thoracic Surgery Authors: E. Pelce, A. Porto, V. Gariboldi, A. Ben Lagha, C. Amanatiou, F. Collart, A. Theron Tags: ORIGINAL ARTICLE Source Type: research

Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. 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 Irvine, Calif.-based company said. “With the Edwards Centera valve, European clinicians and their patients may now benefit from a self-expanding ...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Edwards Adds Bold New Chapter to TAVR Story
Edwards Lifesciences just might have leaped-frogged over some of its competitors in the burgeoning  TAVR market. The undisputed TAVR pioneer has received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards Centera valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system. The company said the device is packaged with the valve fully pre-attached to the delivery system, which helps with simple and rapid device preparation. Network with your colleagues in medtech at ADM Cleveland, ...
Source: MDDI - February 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Medical Device Business Source Type: news

Edwards launches US pivotal Centera self-expanding TAVR study
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 endpoint fo...
Source: Mass Device - October 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Replacement Heart Valves Edwards Lifesciences Source Type: news

Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
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 Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news

Periprocedural Predictors of New-Onset Conduction Abnormalities After Transcatheter Aortic Valve Replacement.
CONCLUSIONS: Computed tomography assessment of membranous septal anatomy and implantation depth predicted CAs after TAVR with new-generation valves. Future studies are required to identify whether adjustment of the implantation depth can reduce the risk of CAs and adverse clinical outcomes. PMID: 32879221 [PubMed - as supplied by publisher]
Source: Circulation Journal - August 31, 2020 Category: Cardiology Authors: Matsushita K, Kanso M, Ohana M, Marchandot B, Kibler M, Heger J, Peillex M, Trimaille A, Hess S, Grunebaum L, Reydel A, De Poli F, Leddet P, Rischner J, Plastaras P, Jesel L, Morel O, Ohlmann P Tags: Circ J Source Type: research

Transcatheter edge-to-edge repair following surgical valve repair with ring implantation: Results from the multicentre "Clip-in-Ring" registry
CONCLUSIONS: TEER in patients with failed mitral ring is feasible and safe. Further studies shoulddelineate its exact role in the therapeutic armamentarium for this medical issue.PMID:36115768 | DOI:10.1016/j.acvd.2022.05.009
Source: Archives of Cardiovascular Diseases - September 17, 2022 Category: Cardiology Authors: Guillaume Leurent Vincent Auffret Daniel Grinberg Robin Le Ruz Christophe Saint Etienne Romain Pierrard Didier Champagnac Thomas Benard Guillaume Lecoq Marc Antoine Arnould Guillaume Bonnet Thibault Lhermusier Amedeo Anselmi Herv é Corbineau Erwan Donal Source Type: research