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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
LimFlow System Demonstrates Excellent Sustained Amputation-free Survival and Wound Healing at 1 Year in PROMISE I U.S. Study
LimFlow notes the results were presented in the Late-Breaking Data session at the VIVA Conference by Daniel Clair, MD, PROMISE I principal investigator and chair of the department of surgery at the University of South Carolina (USC) and Prisma Health-USC Medical Group.
Phase 1 Study Measuring Dosing Effects of LSD Completed: Results of Study Will Aid In Planning a Phase 2 Study
The study was conducted in partnership with University Hospital Basel's Liechti Lab.
Ellipsys System Creates Fused, Permanent Vascular Access for Dialysis: Case Report Published in the Journal of Vascular Surgery
Ellipsys System creates a type of dialysis access known as a percutaneous arteriovenous fistula (pAVF) for patients with end-stage renal disease (ESRD) who require hemodialysis.
Advanced Chemotherapy Technologies Achieves $5.5M Series A Financing: Company to Pursue First Clinical Trials of ACT-IOP-003 Targeting Advanced Pancreatic Cancer
The capital will be used to fund initial clinical development of the company’s ACT-IOP-003 local chemotherapy system for the treatment of locally advanced non-resectable and borderline resectable pancreatic cancer.
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.