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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Leman Micro Devices: World-first Clinical Trial Update
Dr. K. Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness”.
HeartPoint Global Announces Successful Pre-Clinical Trial of New Implant System
“It is encouraging to see that our Implant System has seen significant results in pre-clinical testing, especially as we prepare for our first clinical trials,” said Seth Bogner, Chairman & CEO of HeartPoint Global.
Neovasc Enrolls First Patient in COSIRA-II Trial for Neovasc Reducer; Up 1.6%
The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (PMA) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.
Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation
The patient, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS™ cryoablation and pulsed-field ablation (PFA) consoles.
Pulnovo Medical Announced Results From PADN-CFDA Pivotal Trial
The data from the PADN-CFDA pivotal study meet the primary efficacy and safety endpoint.
Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA Study
The Lacrosse NSE ALPHA has unique nylon elements on the exterior of the balloon that focus dilation force to reduce balloon slippage during inflation in hard or fibrotic coronary lesions.
European Society of Cardiology Heart Failure Journal Publishes New Plasma Volume Heart Failure Study Data from FAST BioMedical
The objective of this study was to assess the relationship of changes of measured plasma volume with changes in hemoglobin and hematocrit in patients with acute heart failure.
Zynex Monitoring Announces First Enrollment in a Hemodialysis Clinical Trial for its Fluid Monitoring System
The study, conducted at DaVita Clinical Research clinics, is aimed at further characterizing changes in the device's patented Relative Index during hemodialysis procedures where a large volume of fluid is removed from patients.
1st Patient Enrolled in Pivotal Clinical Trial Evaluating the Hydrus Microstent in Standalone MIGS for Mild to Moderate Glaucoma
The FRONTIER trial will build on long-term findings from the Hydrus HORIZON five-year pivotal trial, which showed a 47% reduction in visual field loss, sustained reduction in medication use, and over 60% reduction in subsequent, more invasive glaucoma surgery.