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

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AbstractA 6-month-old infant with a double outlet right ventricle, doubly committed ventricular septal defect, and right ventricle outflow tract (RVOT) stenosis underwent intracardiac repair with RVOT reconstruction using a fresh decellularized allograft derived from a 1-year-old heart transplant recipient in Japan. Early postoperative evaluation via echocardiography and cardiac magnetic resonance imaging revealed that the pulmonary allograft and cardiac function were stable. This is the first case report on using a decellularized heart valve, which was resected from a heart transplant recipient, for primary repair of cong...
Source: General Thoracic and Cardiovascular Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Abbott Laboratories has hit a substantial milestone in its plan to bring the Tendyne transcatheter mitral valve replacement (TMVR) system to the U.S. market. The Abbott Park, IL-based company said it has initiated SUMMIT, a pivotal clinical study of the TMVR system. Up to 1,010 patients will be enrolled in up to 80 sites in the pivotal trial. Abbott said the investigational Tendyne device is the first and only mitral valve replacement that can be repositioned and fully retrieved, allowing the surgeon to precisely place the device during implantation, which could improve patient outcomes. Tendyne is a tri-leaflet, bioprost...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Cardiovascular Source Type: news
Abbott (NYSE:ABT) said today it launched a US-based pivotal clinical study of its Tendyne transcatheter mitral valve replacement system designed to treat mitral regurgitation. In the trial, the Abbott Park, Ill.-based company will explore the safety and efficacy of the system in treating patients with mitral regurgitation. Abbot touted the Tendyne as the first and only mitral valve replacement designed to be retrievable and repositionable. “Transcatheter mitral valve replacement represents a new frontier in treating people whose valve does not close properly and who would benefit from a replacement valve in...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Tendyne Holdings Source Type: news
An avid triathlete and marathon runner, Gil Solomon was concerned when an echocardiogram test done in 2014 showed that he had a congenital defect in his heart called bicuspid aortic valve disease. His aortic valve only had two cusps, or leaflets, that opened and closed to regulate blood flow instead of the normal three. The defect causes the valve to narrow, which strains the heart and reduces or blocks blood flow from the heart to the body. The same defect may also weaken the walls of the aorta, the main artery from the heart, which can lead to a tear.Many people, like Solomon, are unaware they have the condition until it...
Source: UCLA Newsroom: Health Sciences - Category: Universities & Medical Training Source Type: news
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentin...
Source: Mass Device - Category: Medical Devices Authors: Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news
Abbott (NYSE:ABT) won FDA approval for the third generation of its MitraClip transcatheter heart valve repair device, the company said today. Acquired in the $410 million acquisition of Evalve back in 2009, MitraClip won its first FDA nod in 2013. Abbott said today that the latest iteration won CE Mark approval in the European Union earlier this year. The new version upgrades MitraClip’s steering, navigation and positioning capabilities and a second clip size with expanded reach, the Chicago-area healthcare giant said. “Abbott engineers designed these enhancements based on feedback from doctors to improve ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Publication date: Available online 28 May 2018Source: Drug Discovery Today: Disease ModelsAuthor(s): Arash Kheradvar, Ramin Zareian, Shimako Kawauchi, Richard L. Goodwin, Sandra RugonyiValvular heart disease is the third-most common cause of heart problems in the United States. Malfunction of the valves can be acquired or congenital and each may lead either to stenosis or regurgitation, or even both in some cases. Heart valve disease is a progressive disease, which is irreversible and may be fatal if left untreated. Medications cannot currently prevent valvular calcification or help repair damaged valves, as valve tissue i...
Source: Drug Discovery Today: Disease Models - Category: Drugs & Pharmacology Source Type: research
AbstractPercutaneous treatment of atrioventricular (AV) valve disease has long been restricted to therapy of mitral stenosis, and was only lately expanded to mitral regurgitation. 15  years ago the MitraClip edge to edge repair was first applied to human pathology. In Europe, German centers were the first to widely adopt this technique in patients with mitral regurgitation and high or inappropriate risk for surgery. Given the exponential rise in implantation procedures, experti se of the operators and investigator initiated investigations substantially contributed to improvements in procedural processes and patient se...
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
CONCLUSION: The STS 2008 risk scores were suitable for major postoperative complications in patients undergoing single valve surgery, except for Reop and SLOS. PMID: 30084779 [PubMed - in process]
Source: The Heart Surgery Forum - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Heart Surg Forum Source Type: research
At this week’s Computer Assisted Radiology and Surgery conference (CARS 2018) in Berlin, scientists from the Fraunhofer Institute for Medical Image Computing in Germany will be showing off their unique software that helps to fix cardiac va...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Radiology Source Type: blogs
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