Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Amplatzer Amulet Left atrial appendage occluder Stroke prevention product for people with atrial fibrillation First analysis of 1-year clinical outcomes from the roll-in cohort of the Amulet IDE trial demonstrated a high implant success rate of 99.0% and a low rate of procedural complications at 3.5%
Abbott Laboratories, of Abbott Park, Ill. Mitraclip Small clip that is attached to the mitral valve For mitral regurgitation (MR) Real-world outcomes from 4 separate analyses of the global EXPAND study showed significant MR reduction (to ≤1+ in 87.1% of patients at 30 days for primary MR and 90.1% in patients with secondary MR) was consistently achieved with Abbott's Mitraclip NTR/XTR systems in patients with either primary or secondary MR; the EXPAND study is the largest contemporary investigation of real-world Mitraclip outcomes studying more than 1,000 patients who received Abbott's third-generation device, Mitraclip NTR/XTR, at 57 sites worldwide
Abbott Laboratories, of Abbott Park, Ill. Tendyne Transcatheter mitral valve implantation system For mitral regurgitation (MR) Clinical outcomes from an analysis of 100 patients with symptomatic, moderate-to-severe or severe MR treated in the EU Clinical Study of Tendyne demonstrated durability of MR elimination in 93.2% of patients and significant improvements in quality of life and functional capacity at 2 years; this study data supports the valve as a safe treatment option that provides symptom relief and improved quality of life for people with symptomatic MR who are not eligible for open-heart surgery or transcatheter mitral valve repair
Abbott Laboratories, of Abbott Park, Ill. Triclip Minimally invasive, clip-based tricuspid valve repair device For tricuspid regurgitation (TR) Data from the TRILUMINATE CE mark study, which included 85 patients from Europe and the U.S., showed strong TR reduction in 87.1% of patients who received Abbott's Triclip and a low all-cause mortality rate of 7.1% at 1 year; also showed sustained improvements in right heart function demonstrating the benefits of tricuspid valve treatment; by meeting the primary safety and efficacy endpoints, the TRILUMINATE research team concluded that Triclip is a safe and durable treatment option for high-risk patients with symptomatic moderate or greater TR
Dayzz Ltd., of Hertzelia, Israel Dayzz Sleep app based on machine learning Provides personalized sleep training plans Published study validating its sleep assessment machine learning engine in Sleep Medicine; a Digital Sleep Questionnaire was administered to 3,799 volunteers, of which 2,113 were eligible and consented to the study; of those, 247 were interviewed by expert sleep physicians, who diagnosed ≤2 sleep disorders; machine learning trained and validated separate models for each diagnosis; Elasticnet models validated each diagnosis with high sensitivity (80-83%), acceptable specificity (63-69%), high AUC (0.80-0.85) and good accuracy (agreement with physician diagnoses, 68-73%)
Elixir Medical Corp., of Milpitas, Calif. Dynamx Coronary Bioadaptor system Metallic drug-eluting coronary artery device designed to open and support the artery during healing For coronary artery disease 12-month data demonstrated no target vessel revascularization or device thrombosis; reported
vessel and implant expansion (3% and 5% increase in mean area, respectively) and no loss of mean lumen area, demonstrating positive adaptive remodeling and the device's ability to preserve blood flow over time; had mean acute gain of 1.63 mm (±0.34), demonstrating radial strength; in-device mean late lumen loss was 0.12 mm (±0.18), demonstrating the ability of the device and drug coating to inhibit disease progression
InspireMD Inc., of Tel Aviv, Israel Cguard Embolic prevention system For the prevention of stroke caused by carotid artery disease treatment Presented results from SIBERIA study that evaluated 30-day silent brain infarcts associated with the use of the Acculink conventional open-cell nitinol stent vs. the Cguard Micronet-covered stent; evaluated 100 patients who qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either Cguard or Acculink; postprocedure (24-48 hours), the Cguard arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm3 vs. 700 mm3), a statistically significant improvement (p=0.007); at 30 days, diffusion weighted magnetic resonance imaging showed 0 new cerebral lessons in the Cguard arm vs. 6 in the Acculink arm (p=0.03); at 30 days, there were 0 strokes, myocardia infarctions or deaths in the Cguard arm and 3 events the Acculink arm (2 strokes and 1 myocardial infarction)
Medtronic plc, of Dublin Symplicity Renal denervation (RDN) system For patients with hypertension Data from the Global SYMPLICITY Registry showed RDN led to significant and clinically meaningful reductions in blood pressure (BP) that were sustained out to 3 years postprocedure (17 mmHg office systolic blood pressure), with more patients achieving BP below 140 mmHg, while those at very high BP levels experiencing drops into lower risk BP ranges; the number of patients at the very highest BP level – greater than 180 mmHg systolic at baseline – dropped by two-thirds at 3 years; the number of patients who had reported office systolic BP less than 140 mmHg – a more controlled level of BP – increased from 13% at baseline to 39% at 3 years; the BP drops occurred while patients were prescribed an average of 4 or more anti-hypertensive medications, which remained unchanged over 3 years; the absence of increase in medications suggest that RDN's effect was independent of anti-hypertensive medication burden; RDN continued to show a strong safety profile at 3 years with an incidence of renal artery stenosis of 0.3%, which is within the expected range for patients with hypertension not undergoing denervation
Sintx Technologies Inc., of Salt Lake City Silicon nitride Industrial ceramic Reduces the spread and transfer of pathogens Study published in bioRxiv demonstrated that silicon nitride inactivates the SARS-CoV-2 virus within a minute after exposure

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