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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
NuVision ICE Catheter: Positive Results From First-in-human Feasibility Study Reported At 2020 TCT Conference
"Initial clinical experience of the NuVision ICE Catheter supports safe and effective use with all primary and secondary safety and performance endpoints met and zero adverse events reported," commented Dr. Latib.
Head-to-Head TAVR 700 Patient Study Comparing the Evolut™ TAVR Platform Against the Edwards SAPIEN Valve in Small Annulus Patients
The SMall Annuli Randomized To Evolut™ or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic Evolut™ PRO and PRO+TAVR Systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards Lifesciences.
SONATA FDA IDE Pivotal Trial Long Term Results Published in the Journal of Gynecologic Surgery.
The outcomes reported in the paper build upon the previously published 12-month and 24-month outcomes, demonstrating the sustained durability of patient benefits through three years which include a significant reduction in fibroid related symptoms.
ADEXUSDx® COVID-19 Antibody Test Independent Study Demonstrates 100% Specificity and 94.3% Sensitivity That Meets the Requirements for Clinical Use
October 12, 2020
ADEXUSDx® COVID-19 antibody test update: Now Diagnostics announced that an independent validation study of the ADEXUSDx® COVID-19 antibody test conducted by the...
Varian Receives IDE: Prepares for 1st Ever Clinical Trial of FLASH Therapy
FLASH therapy, involving ultra-high dose rates, and delivery in typically less than one second, may be over 100 times faster compared to conventional radiation therapy.
Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel
The company is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C™ implant superiority over the current surgical standard of care – microfracture and debridement.
PRISTINE Study with SELUTION SLR Sirolimus Drug Eluting Balloon: First Two Patients Enrolled
The PRISTINE registry is a follow up to the encouraging results seen in the PRESTIGE clinical trial (Below The Knee, Chronic Limb Threatening Ischemia) at 6 months.
Neuromod Devices Publish Positive Results from Large Scale Tinnitus Clinical Trial
Neuromod notes the clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.
Cardiovascular Systems Announces Presentation of Data From Large Coronary Orbital Atherectomy Study at the TCT Connect 2020 Conference
This is a large retrospective observational study from a high volume, tertiary center treating complex severely calcified de novo coronary lesions that underwent lesion preparation with OAS before stent deployment.
