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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
New 12-month Results from the VATRAC Trial Confirm Durable Efficacy of Aerin Medical’s VivAer® in Patients with Nasal Valve Collapse
Study shows VivAer was effective in reducing symptoms of nasal airway obstruction for patients with both dynamic and static nasal valve collapse.
Shape Memory Medical Completes Enrollment in the AAA-SHAPE Early Feasibility Study
Michel Reijnen, MD, PhD, principal investigator for AAA-SHAPE Netherlands and vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands added, “Although we are still early in the course of patient follow-up, we are seeing signals of impressive sac shrinkage at six months and one year. We look forward to the ongoing evaluation of these patients and how their aneurysms respond longer-term.”
First Patient Treated in U.S. Pilot Trial Evaluating the eShunt System in Patients with Normal Pressure Hydrocephalus
The eShunt System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure.
Medtronic Extravascular ICD Meets Global Clinical Trial’s Safety and Effectiveness Endpoints
Late-breaking data presented at ESC Congress 2022 and simultaneously published in The New England Journal of Medicine confirms implant procedure safety and defibrillation success reports Medtronic.
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.