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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
CLAAS Stroke Prevention Technology: Promising Clinical Results Presented at 2020 TCT Conference
Both studies investigated Conformal's CLAAS® Technology, a next-generation solution for sealing the left atrial appendage (LAA) in patients with atrial fibrillation.
BrainCool AB Announces Statistically Significant Late-Breaking Clinical Data at ESMO Virtual Congress 2020
The data was collected from a Nordic multi-center pivotal trial led by Karolinska University Hospital, Stockholm, that enrolled 182 patients with multiple myeloma or lymphoma who were scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation.
Coala Heart Monitor Late-breaking Trial Published in BMJ Advises Coala Life
Coala Heart Monitor was used to evaluate 100 patients after cryptogenic stroke. Patients were recruited from two stroke units in Sweden that underwent scheduled monitoring twice daily, and when symptoms occurred, for 28 days in everyday life.
Diamondback 360 Coronary Orbital Atherectomy System Large Study Demonstrates Exceptional Safety and High Procedural Success: Reported at TCT Connect 2020
Diamondback 360 Coronary Orbital Atherectomy System Large Study shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy prior to stent deployment.
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.