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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Graphene Sensors May Help to Detect Sepsis Earlier in Critically Ill Patients
A new study from the University of Bath has shown that graphene-based biosensors, designed by Integrated Graphene, have the potential to play a major role in detecting increased levels of lactate, an important biomarker for the treatment of critically ill patients.
Gore announces First U.S. Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study
The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia. "With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial," he said.
Unweaving the Microscopic Threads of Alzheimer’s Tapestry: Single-cell Dissection of Vascular Changes Across Six Brain Regions
Shining new light on the labyrinth of human brain vessels, researchers map 22,500 vascular cells from 428 donors and six brain regions, revealing key insights for Alzheimer's disease onset and potential treatment.
Hoag Hospital Clinical Study Demonstrates Luna Reduces Post-surgical Rehab Costs by 52%
The Hoag Orthopedic Institute study showed that with the Luna care model, participating surgeons reduced their home health utilization by 86%, resulting in decreased blended costs of $2,517 per case. Patient outcomes also improved as readmission rates were reduced by 28%, compared with patients that received the traditional home health option.
Know Labs’ Non-Invasive Glucose Monitoring Technology Shows Improved Accuracy
Like all previous Know Labs clinical studies, this study was designed to assess the ability of the Bio-RFID sensor to non-invasively and continuously quantify blood glucose, using the Dexcom G6® continuous glucose monitor (CGM) as a proxy for the measurement of blood glucose.
Parkinson’s AI Proves Accuracy In Clinical Studies Reports PD Neurotechnology
Nikos Moschos, Managing Director of PD Neurotechnology, comments: “Our monitoring device is a game-changer in the fight against Parkinson’s. Studies confirm that it is effective and easy to use, and we have seen time and again how it facilitates better treatment decisions for patients based on real-world data. By providing accurate and continuous data on symptoms, together with an ecosystem to collect and present effectively, we are always aiming to help improve the management of Parkinson’s and hopefully enhance patients' quality of life.”
Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies
Boston Scientiic reports the results from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation (AF), included an extension arm for the POLARx FIT Cryoballoon Catheter, a single device capable of enabling 28 and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints and included 50 patients who were treated with at least one application of the 31mm cryoballoon and will be followed for 12 months. At the time of data release, patients had undergone six out of a total of 12 months of follow up.
First Multi-Center Study Combining the Allurion Program With GLP-1 Therapy Presented at the European Congress on Obesity
The retrospective study was conducted across 3 obesity centers in Italy, Spain and Egypt. In total, 181 patients with BMIs of 27 and above were enrolled in the Allurion Program with Saxenda® (liraglutide) added once daily starting 4 to 16 weeks after balloon placement. On average, the duration of drug treatment was just over 4 months (4.1 ± 2.2 months).
EuroPCR 2023: Late-Breaking Clinical Data Demonstrate Elixir Medical’s DynamX Bioadaptor Restores Vessel Motion and Function with Better Effectiveness at 12 Months Compared to a...
DynamX Bioadaptor is a new type of coronary implant designed to unlock the scaffold, uncage the vessel, to return normal vessel motion and function after percutaneous coronary intervention (PCI), with continued dynamic support of the atherosclerotic vessel to reduce long-term adverse events. In the study, the bioadaptor demonstrated superior effectiveness of its unique mechanism of action across secondary intravascular imaging endpoints, achieving restoration of the vessel motion and function compared to persistent constraint with DES.