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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
physIQ Announces Collaboration with InCarda Therapeutics and Syneos Health to Accelerate Innovative Phase III Restore-1 Study in Patients with Atrial Fibrillation
The Phase III RESTORE-1 study is highly innovative in its use of wearable sensors and the FDA-cleared AF digital biomarker developed by physIQ.
IRRAS Announces First Patient Treatments at Mount Sinai Health System in New York as Part of the DIVE Study
The DIVE study is a retrospective and prospective cohort, controlled, single-center, phase 1 study with a primary objective of evaluating the safety and radiographic outcomes associated with using IRRAS' IRRAflow system compared to the current standard of care with external ventricular drains.
1st US Patient Now Enrolled in SELUTION SLR IDE Peripheral Study
The aim of the SELUTION4BTK clinical trial is to demonstrate the superior efficacy and equivalent safety of SELUTION SLR compared to plain (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in Chronic Limb Threatening Ischemia (CLTI) patients.
Restore EF Study Shows Heart Function, Symptom Improvements for High-Risk PCI Patients Supported by Impella
Restore EF Study is a prospective, multi-center study evaluating the best practices in contemporary PCI practice, including more complete revascularization. Participants received an Impella-supported high-risk PCI, also called an “on-pump PCI,” at one of 22 sites across the United States between August 2019 and May 2021.
Zynex Announces 1st Enrollments in Apheresis Donation Clinical Trial with Second Generation Fluid Monitoring System
"The data collected with the CM-1500 in the earlier phases of the apheresis trial was encouraging and incredibly valuable for improving accuracy of the CM-1600 Relative Index," said Donald Gregg, VP of Zynex Monitoring Systems.
Aethlon Medical Announces Publication of Peer-Reviewed Journal Article Describing Hemopurifier Resin Binding of Seven COVID-19 Variants
"These data demonstrate that the Hemopurifier can effectively capture a wide range of clinically relevant SARS-CoV-2 variants," said Charles J. Fisher, M.D., Chief Executive Officer of Aethlon Medical.
Adagio Medical Announces Publication of Cryocure-2 Data
"The publication of Cryocure-2 data is seen as a significant step in the validation of Adagio's ULTC technology," said Olav Bergheim, President and CEO of Adagio Medical.
Artivion Initiates Enrollment in PERSEVERE Clinical Trial
Artivion advises the trial is designed to support the company's forthcoming application to the U.S. Food and Drug Administration for premarket approval of the AMDS.
Positive Results from Preclinical Studies of Embrace Hydrogel Embolic System in Hemorrhage Models
Embrace Hydrogel Embolic System is an investigational device intended to be used to embolize peripheral arterial bleeds in vessels ≤ 6 mm