HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Reflow Medical Enrolls First Patients in the DEEPER LIMUS Study of the Temporary Spur Stent System
Reflow Medical notes the OUS single-center clinical trial (NCT04162418) is expected to enroll up to 30 participants and last approximately six months.
Insulet Resumes Pivotal Study of its Next-Generation Product – Omnipod, Powered by Horizon™
Insulet expects to commercialize Omnipod, Powered by Horizon, in the U.S. in the first half of 2021, pending clearance by the FDA.
The Annals of Thoracic Surgery Published In Vivo Study Concludes Hemovent’s MOBYBOX ECLS Device Provides “Excellent (Long-Term) Safety and Physiologic Efficacy”
Hemovent reports the study concluded that Hemovent’s MOBYBOX ECLS device “provides excellent safety and physiologic efficacy in a 7-day (long-term) sheep experiment without visible clotting, hemolysis, or sustained reductions in fibrinogen or platelets.”
The Journal of Bone and Joint Surgery Published Article Shows Smith+Nephew’s OXINIUM on XLPE for Total Hip Arthroplasty as Best Performing Bearing Beyond 10...
Total hip arthroplasty using a bearing combination of OXINIUM on XLPE versus traditional ceramic or metal constructs results in greatly improved survivorship and significantly reduced the need for revision. Read more.
IMPACT Study Found a 25% Reduction in Total Healthcare Costs Associated with Earlier Prosthetic Care
The IMPACT study utilized the IBM Watson Truven Health Marketscan, a national commercial claims database, and analyzed data on 510 patients with lower limb amputations.
Non-Pharmaceutical Clinical Trial Starts Using Photobiomodulation to Treat Intubated COVID-19 Patients
Approved by the Ministry of Health in Brazil, a group of international physicians and scientists are in the early stages of data collection utilizing Multi Radiance Medical’s handheld super pulsed laser therapy devices to improve the condition of patients.
First Patient Enrolled in Phase 1 Natural Vascular Scaffolding Clinical Trial
The therapy is designed to open vessels and keep them open without the use of permanent implants in the treatment of peripheral artery disease (PAD) of the lower extremities, a painful and debilitating condition affecting over 200 million people worldwide.
OrthogenRx Announces Response in The Journal of Bone and Joint Surgery
OrthogenRx notes the recently published response counters this position and addresses some recently reported economic and medical benefits not acknowledged within the AAOS CPGs.
Shuwen Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its Breakthrough Preeclampsia Detection Device in Unselected Women
The paper, entitled “Late pregnancy screening for preeclampsia with a urinary point-of-care test for misfolded proteins”, was written by collaborators from China Medical University's Shengjing Hospital and Columbia University Medical Center in New York and demonstrates the ability of the test to detect preeclampsia at a high level of accuracy in women admitted to the hospital for any reason. The findings included over 1,500 women and were published in the peer-reviewed journal PLOS One.