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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Publication Demonstrates Ability of Sera Prognostics’ PreTRM Biomarker Test as a Predictor of Adverse Pregnancy Outcomes
The results of the study, which were selected for a podium presentation at the 40th Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine in February 2020, demonstrate that the company’s PreTRM® biomarker test can be used to predict very preterm birth, (infants born before 32 weeks of gestation) as well as increased length of neonatal hospital stay and severe adverse neonatal outcomes.
Early Identification of Acute PE Identified with EarlySense Technology
The report includes findings from a case study at Hebrew Home of Riverdale by RiverSpring Health showing that skilled nursing facilities incorporating contact-free, continuous patient monitoring can potentially aid in the early identification of acute changes in patient deterioration and rapid life-threatening treatment interventions.
Positive Two-Year Data from the ALPS Registry of the LimFlow Percutaneous Deep Vein Arterialization (pDVA) System
The ALPS Registry is a multi-center, retrospective study conducted at centers in Alkmaar, Netherlands; Leipzig, Germany; Paris; and Singapore encompassing 32 end-stage – or “no-option” – CLTI patients.
PROTECT III Study Shows Placing Impella Prior to High-Risk PCI is Associated with Lower Mortality Compared to Bailout PCI
PROTECT III Study data presented is from an adjunct study of PROTECT III, the ongoing, prospective FDA post-approval study for Impella in high-risk PCI.
Rabin Medical Center Announced They Will Initiate Clinical Trials to Test Feasibility of Exero Medical’s Wireless Anastomotic Sensor
Researchers at Rabin Medical Center will use Exero’s system to collect data from the sensor during low anterior resection surgery. The results of the trial will enable the company to refine its detection algorithms based on real-life data.
Balt Begin the STEM Trial: Receives IDE Approval From the FDA
The clinical trial is a prospective, randomized controlled trial.
Publication of TOBA III Clinical Trial Results in the Journal of Vascular Surgery
TOBA III Clinical Trial: “We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack Endovascular System for focal dissection repair when treating lesions both above- and below-the-knee.”
New Data Unveiled at Heart Rhythm 2020 Demonstrate Effectiveness of App-Based Remote Monitoring of Medtronic Cardiac Devices, Significant Reduction in Complications with Micra Leadless...
During the current COVID-19 pandemic, procedures, and therapies that reduce exposure to other people are important because that also reduces the potential for spreading the virus. The results were presented at the annual Heart Rhythm Society Scientific Sessions, held virtually for the first time.
PINNACLE FLX Study of the WATCHMAN FLX™ Left Atrial Appendage Closure Device Presented as Late-Breaking Clinical Trial at HRS 2020 SCIENCE
PINNACLE FLX clinical trial assesses the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation