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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
WATCHMAN FLX Left Atrial Appendage Closure Device Trial Initiated Reports Boston Scientific
The device will be compared to treatment with non-vitamin K antagonist oral anticoagulants (NOACs), considered the leading contemporary drugs for stroke risk reduction in this population.
Selective Cytopheretic Device Study in Pediatric Patients with Acute Kidney Injury Shows Positive Results
Selective Cytopheretic Device study's primary objective was to assess the safety of the device in children. Safety was determined by adverse events related to treatment up to 60 days following treatment initiation.
Guided Therapeutics Reports After Meeting with FDA They Will Start Study in Support of its Application for FDA Approval
The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan (i.e., FDA approval). The Company filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.
DTM Spinal Cord Stimulation 12 Month Study Results Reported by Medtronic
At 12 months, 84% of patients with chronic back pain treated with DTM Spinal Cord Stimulation reported at least 50% pain relief, compared to 51% of patients treated with conventional SCS (p=0.0005).
IN.PACT BTK Nine Month Study Results Presented in Late-Breaking Clinical Trial Sessions at TCT Connect Annual Meeting
IN.PACT BTK study is a prospective, multi-center, 1:1, randomized feasibility study assessing the safety and effectiveness of the IN.PACT 0.014 DCB, a 3.5 μg/mm2 dose paclitaxel-coated balloon, versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries. The study enrolled 50 subjects at nine sites in Europe.
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.