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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 Abbott Laboratories has had another stellar year in terms of new product launches and strong growth drivers across the company. In fact, the company's pipeline may be the strongest its ever been, thanks to products like the FreeStyle Libre glucose monitoring system, the MitraClip, the HeartMate3, and the Alinity family of diagnostic products – just to name a few. "It's interesting, I've never in my career here seen such breadth across the company in new products, new product launches, market conditions, et cetera," CEO Miles White said during Abbott's third-q...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
The first patient in the transcatheter arm of a European study has been treated with Micro Interventional Devices’ MIA technology for tricuspid and mitral repair, the company said. A team at Vilnius University Hospital Santariskiu Clinic (Vilnius, Lithuania) used the 12F MIA (minimally invasive annuloplasty) delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and tricuspid regurgitation (TR) in the patient. The 61-year-old female was suffering from severe torrential tricuspid regurgitation. The physicians were able to reduce the dilated tricuspid annulus by 29%, from 20.9cm2 to 14.9...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog Cardiac Implants Featured Research & Development Micro Interventional Devices Source Type: news
A clip used to repair damaged heart valves sharply reduced deaths among patients with a grim prognosis.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Heart Surgery and Surgeons heart failure Source Type: news
Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial. The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. The first patient in the trial was enrolled and ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Cardiac Dimensions Source Type: news
Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial. The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. The first patient in the trial was enrolled and ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Cardiac Dimensions Source Type: news
Authors: Isbir S, Arsan S, Ak K, Cobanoglu A Abstract The case is reported of a 62-year-old man with severe aortic regurgitation that was related to failed prior valve-sparing ascending aortic aneurysm repair, and who was successfully treated with a Perceval Sutureless valve. PMID: 30207129 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis 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
CONCLUSIONS: An elevated RDW is associated with a worse outcome following valve surgery. The predictive ability of the RDW, when assessed by the area under the ROC curve, improved the predictive ability of the EuroSCORE II calculator. PMID: 30207123 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
CONCLUSIONS: Mitral valve repair using artificial chordae reconstruction combined with ring annuloplasty is effective for treating regurgitant parachute mitral valve in adults. PMID: 30207119 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Survival Advantage of MitraClip® Over Medical Treatment in Patients with Mitral Regurgitation: A Meta-Analysis. J Heart Valve Dis. 2017 Nov;26(6):651-658 Authors: Benito-González T, Estévez-Loureiro R, Iglesias-Gárriz I, Gualis J, Pérez de Prado A, Garrote C, Swaans MJ, S Van der Heyden JA, Feldman T, Giannini C, Alonso D, Rodriguez-Santamarta M, Castaño M, Fernández-Vázquez F Abstract BACKGROUND: The MitraClip® system is a percutaneous treatment for mitral regurgitation (MR) that has shown promising results in patients who are inoperable or at h...
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
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