SynCardia denies competitor ’ s market exit claim

SynCardia Systems isn’t exiting the market quite yet, according to a press release posted today in response to a competitor’s claim. Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves. “SynCardia’s machine works quite well. But it’s a very old machine with a big air compressor … I’m not surprised that they’re heading out of the market,” said artificial heart developer Carmat’s chief exec Marcello Conviti, according to an article on Seeking Alpha. The company said that it will “emerge from Chapter 11 reorganization” with a new owner, Sindex, on September 16, and went on to contest each point in Conviti’s statement. Syncardia touted the functionality of the device, saying its products account for 1,625 of the total 1,688 artificial hearts that have been implanted since 1969, and said that statistics from an International Society for Heart and Lung Transplantation indicated that 73.5% of patients implanted with the device were either alive or transplanted with a new heart at 6-months, and touted it as the “highest bridge to transplant rate of any durable device.” The company touted upgrades to its air compressor, saying it has received clearance from the FDA, CE Mark approval in the European Union and Health Canada approval for upgrades to the heart, including new drivers and portable drivers, over the l...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Cardiac Implants Cardiovascular SynCardia Source Type: news

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Authors: Han B, Wang Q Abstract Pulmonary hypertension due to left heart disease (PH-LHD) is caused by left ventricular (LV) systolic and/or diastolic dysfunction and left heart valve disease. LV diseases lead to left ventricular filling pressure increases, pulmonary venous obstruction and pulmonary venous pressure increases, and thus to secondary PH. Exercise tolerance is lower and fatality rates are higher in patients with PH-LHD than those in subjects with normal pulmonary arterial pressure. In spite of the progress in the study of the mechanisms of PH-LHD in recent years, no specific treatment is currently avai...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
ConclusionsThese preliminary results strongly support the use of VKORC1 (−1639G>A) rs9923231 polymorphism for genetically guided initial warfarin dosing in South Indian patients with heart valve replacements.
Source: Indian Heart Journal - Category: Cardiology Source Type: research
ConclusionsPPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes. Longer-term outcomes remain to be described. Clinicaltrials.gov identifier NCT02777892.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
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
AbstractTranscatheter aortic valve replacement (TAVR) is being extended to younger patients. However, TAVR-compatible bioprostheses are based on xenogeneic materials with limited durability. Off-the-shelf tissue-engineered heart valves (TEHVs) with remodeling capacity may overcome the shortcomings of current TAVR devices. Here, we develop for the first time a TEHV for TAVR, based on human cell-derived extracellular matrix and integrated into a state-of-the-art stent for TAVR. The TEHVs, characterized by a dense acellular collagenous matrix, demonstrated in vitro functionality under aortic pressure conditions (n =&th...
Source: Journal of Cardiovascular Translational Research - Category: Cardiology Source Type: research
Conclusion: in the study sample, we found no relation between perceived stressors at the Intensive Care Unit and hemodynamic instability in the postoperative period of cardiac surgery.
Source: Texto e Contexto - Enfermagem - Category: International Medicine & Public Health Source Type: research
In this study, we investigated whether (p)ppGpp contributes to the pathogenesis of E. faecalis infective endocarditis (IE), a biofilm infection of the heart valves. While the stringent response was not activated in heart valve-associated E. faecalis, deletion of the gene encoding the bifunctional (p)ppGpp synthetase/hydrolase Rel significantly impaired valve colonization. These results indicate that the presence of (p)ppGpp is dispensable for E. faecalis to cause IE, whereas the ability to regulate (p)ppGpp levels is critical for valve colonization. Next, we characterized how basal (p)ppGpp levels affect processes associat...
Source: Microbiology - Category: Microbiology Authors: Tags: Microbiology Source Type: research
Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week. The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years. Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the d...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Replacement Heart Valves Boston Scientific Source Type: news
The interplay with the blood flow and the heart valves, which provide unidirectional blood flow through the heart, is complicated since it involves flow pulsatility and complex, deformable geometries of both the valve and the aorta [1]. Malfunctions of the heart valves can affect the hemodynamics of the whole circulatory system [2,3] and these abnormalities can either be congenital or arise from abnormalities in hemodynamic behavior. Dysfunctional heart valves can usually be replaced with prosthetic heart valves, which, depending on the design and quality of insertion, offer variable hemodynamic performance and may be asso...
Source: Medical Engineering and Physics - Category: Biomedical Engineering Authors: Source Type: research
LivaNova (NSDQ:LIVN) said today it concluded the Prelude first-in-human feasibility study exploring the transseptal use of its Caisson transcatheter mitral valve replacement system designed to treat mitral valve regurgitation. In the study, investigators explored the use of the Caisson TMVR system through a transseptal approach, which the London-based company claims is a less-invasive approach which uses a catheter inserted through an incision in the groin instead of an opening in the chest. LivaNova touted “positive patient outcomes” from the study, but has not released data from it. The company said that...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves LivaNova Source Type: news
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