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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Non-Pharmaceutical Clinical Trial Starts Using Photobiomodulation to Treat Intubated COVID-19 Patients
Approved by the Ministry of Health in Brazil, a group of international physicians and scientists are in the early stages of data collection utilizing Multi Radiance Medical’s handheld super pulsed laser therapy devices to improve the condition of patients.
First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial
The therapy is designed to open vessels and keep them open without the use of permanent implants in the treatment of peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.
OrthogenRx Announces Response in The Journal of Bone and Joint Surgery
OrthogenRx notes the recently published response counters this position and addresses some recently reported economic and medical benefits not acknowledged within the AAOS CPGs.
Shuwen Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its Breakthrough Preeclampsia Detection Device in Unselected Women
The paper, entitled “Late pregnancy screening for preeclampsia with a urinary point-of-care test for misfolded proteins”, was written by collaborators from China Medical University's Shengjing Hospital and Columbia University Medical Center in New York and demonstrates the ability of the test to detect preeclampsia at a high level of accuracy in women admitted to the hospital for any reason. The findings included over 1,500 women and were published in the peer-reviewed journal PLOS One.
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.