LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring

LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure. The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said. “Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. The new larger sizes allow us to treat more patients and pathologies while providing the potential to further improve patient outcomes. With Memo 4D, surgeons can optimize mitral repair procedures rather than replacing the entire mitral valve,” Dr. Sreekumar Subramanian of Nashville’s TriStar Centennial Medical Center, who performed the first Memo 4D implant, said in a prepared statement. The newly cleared device also features the company’s ReChord chordal guide intended to improve procedure times, a new ring design with dimensions better suited to treat enlarged annuli and reduce the risk of systolic anterior motion, LivaNova said. The system also features semi-rigid stability and flexibility and a gradual saddle shape to optimize physiological geometry in an enlarged annuli. “LivaNova is committed to innovation for mitral valve repair and replacement technology. Garnering FDA...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance LivaNova Source Type: news

Related Links:

It was only a matter of time before Abbott Laboratories exercised its option to acquire Cephea Valve Technologies, a company it first invested in back in 2015. The Abbott Park, IL-based company announced on Wednesday it would acquire the mitral valve maker for an undisclosed sum. Cephea's technology is being developed to provide an option for people whose diseased mitral valves need to be replaced. The artificial valve is designed to be delivered through a vein in the leg, forgoing the need for open-heart surgery. Replacement of the diseased mitral valve restores normal blood flow through the heart. "The acquisition o...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news
Boston Scientific (NYSE:BSX) and Edwards Lifesciences (NYSE:EW) said today that they’re burying the hatchet, settling their worldwide patent war over cardiac valve and implant technology, with Edwards paying $180 million to end the dispute. “All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted,” the companies...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Featured Legal News Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences Source Type: news
Leaky heart valves can leave patients struggling for breath and lead to heart failure. Repair usually involves open heart surgery but Michael Hammond, of Hove, had an alternative.
Source: the Mail online | Health - Category: Consumer Health News Source Type: news
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
MitraClip® Repair in Cardiogenic Shock Due to Acute Mitral Regurgitation: From Near-Death to Walking. J Heart Valve Dis. 2018 Jan;27(1):114-116 Authors: Hernández-Enríquez M, Freixa X, Sanchis L, Regueiro A, Burgos F, Navarro R, Masotti M, Sitges M, Sabaté M Abstract A patient with ischemic myocardiopathy who had undergone resynchronization therapy was admitted to the authors' institution with progressive dyspnea. Echocardiography demonstrated a left ventricular ejection fraction (LVEF) of 25%, with a massive mitral regurgitation (MR) secondary to anterior leaflet prolapse and ...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Authors: Saitto G, Lio A, Russo M, Nicolò F, Bassano C, Scafuri A, Nardi P, Ruvolo G Abstract BACKGROUND: Ischemic mitral valve regurgitation (IMR) develops in approximately 10% of patients after myocardial infarction. Surgical management of IMR is controversial, as many series have failed to demonstrate the superiority of mitral valve repair (MVRep) over mitral valve replacement (MVR) in IMR. Moreover, in the setting of MVRep, the choice of ring type is the subject of much debate. The study aim was to evaluate the results of MVRep in IMR with the use of a semi-rigid incomplete C-ring. METHODS: Between J...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Authors: Jensen MO, Jensen H, Skov SN, Levine RA, Nygaard H, M Hasenkam J, Nielsen SL Abstract BACKGROUND: Temporal three-dimensional (3D) analysis of the mitral valve biomechanics has prompted a re-evaluation of surgical approaches and repair device designs to accommodate the natural dynamics of the valve. Such new designs strive to obtain lower annulus restraining forces, resulting in more natural leaflet and chordal stresses. A new annuloplasty system was evaluated using 3D motion and out-of-plane force analysis. It was hypothesized that this system would not impact the valve with adverse motion restrictions or ...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Authors: Rasmussen J, Nielsen Skov S, Ropcke DM, Juan Tjoernild M, Ilkjaer C, Lyager Nielsen S Abstract BACKGROUND: Currently, several different flexible mitral annuloplasty rings are available, and their efficacy for surgical repair of the mitral valve is, in general, considered equal. However, clinical experience indicates differences in remodeling capacity that have not yet been quantitatively assessed. The study aim was to compare the biomechanical properties of two commonly used flexible mitral annuloplasty rings in an acute pig model. METHODS: Medtronic Simulus Flex (n = 5) and Medtronic Duran AnCore (n =...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Researchers from Louisiana have created a 3D-printed full-body phantom that...Read more on AuntMinnie.comRelated Reading: 3D printing technique improves heart valve sizing 3D printing gives pediatric heart surgery a boost 3D-printed lungs improve patient understanding of surgery 3D head models reduce workload for brain radiotherapy 3D printing enhances training for cleft lip repair
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news
A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said. The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said. “As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Source Type: news
More News: Cardiology | Cardiovascular | Cardiovascular & Thoracic Surgery | Gastroschisis Repair | Heart | Heart Valve Disease | Heart Valve Surgery | Heart Valves