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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
NovaSight Announces Positive Pivotal Results of Pivotal Amblyopia Treatment Trial (103 Participants)
The study, which randomized 103 participants aged 4 to 9, compared the improvement in visual outcomes achieved by CureSight digital treatment versus eye patching -- the current gold-standard-of-care treatment.
Royal Phillips Reports New Post-cryptogenic Stroke Remote Telemetry Study
As an initial remote monitoring diagnostic approach, Philips BioTel Heart MCOT detected 4.6 times more patients with atrial fibrillation compared to implantable loop recorder alone. Almost eight times lower costs were achieved with improved detection rates and reduction of secondary stroke risk. Remote cardiac monitoring via the MCOT patch reduced the total cost per patient with detected atrial fibrillation by USD 198,909 compared to monitoring with ILR only. Findings validate 30-day remote cardiac monitoring program as cost-effective standard of care for cryptogenic stroke patients compared to ILR alone
ImpediMed Reports New Bone Data Showing Strong Correlation Between SOZO & DXA in Cancer Patients Presented at 39th Annual Miami Breast Cancer Conference
SOZO Device" demonstrated strong correlation between skeletal muscle mass (SMM) collected using SOZO and bone mineral content (BMC) collected using DXA in three groups: Healthy Subjects, R=0.92, Cancer Patients, During Treatment, R=0.86, and Cancer Patients, After Treatment, R=0.78.
Conformis Reports New Clinical Study Finds Bilateral Knee Conformis Reports Patients Prefer Conformis’ Fully Personalized Solution Over Competitive Off-the-Shelf Implants by a Factor of...
According to the study published in The Journal of Bone & Joint Surgery Reviews (JBJS Reviews)1, patients who had undergone bilateral total knee arthroplasty (TKA) preferred their Conformis fully personalized knee compared to their bilateral off-the-shelf knee at a rate of more than 10 to 1.
WATCHMAN FLX LAAC Device: Late-Breaking Study Results Reinforce Positive Real-World Outcomes
The SURPASS analysis included data from more than 16,000 patients with non-valvular atrial fibrillation within the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry.
iRhythm Technologies: Study Published in JAMA Cardiology Finds Zio by iRhythm Proactively Identifies AFib, Increases Detection Tenfold
iRhythm Technologies advises the transatlantic clinical trial found that Zio by iRhythm, an ambulatory cardiac monitoring solution, led to a tenfold increase in the detection of atrial fibrillation (AF) versus patients receiving standard clinical care.
Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
Cerapedics notes results from the study are intended to be used in a Premarket Approval (PMA) submission to the FDA.
PolyActiva Announces Positive Phase IIa Trial Results in Low Dose Cohort for PA5108 Ocular Implant with Prezia™ Sustained Drug Delivery Technology
The open-label, multicenter, Phase IIa study was designed to evaluate the minimum effective dose of the PA5108 Ocular Implant in patients with mild to moderate POAG across 3 dose cohorts (10 subjects per cohort). Primary and secondary efficacy endpoints include mean diurnal IOP at 12 and 26 weeks compared to baseline, and 8am IOP at 6, 18 and 21 weeks compared to baseline.
ELIOS Vision Reports 8-year follow up results of Its novel ELIOS® Excimer Laser Trabeculostomy Procedure Combined with Cataract Surgery
"This large cohort study provides encouraging evidence that the 'implant free' Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or post-operative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years," said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota.
