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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
LFM Healthcare Solutions Reports Comprehensive Endoscope Study Reveals More Patients Are Potentially Being Exposed to Pathogens
LFM Healthcare Solutions notes he study also notes that these “adverse-event reports” filed by hospitals, endoscope manufacturers, patients and other stakeholders rose markedly in all categories of studied endoscopes from 2014 to 2021 and continued to “increase significantly” from 2019 to 2020 for urological endoscopes and colonoscopes “when the number of elective or non-urgent endoscopic procedures performed during the pandemic decrease in the U.S. and globally
Cardiovascular Systems First In-Human Experience With Company’s Propel™ Percutaneous Ventricular Assist Device
Cardiovascular Systems advises the first series of patients was treated by Dr. David E. Kandzari, MD, FACC, FSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Atlanta, Ga., performed in Tbilisi, Georgia.
First U.S. Trial using GI Genius™ Intelligent Endoscopy Module Report from Medtronic
Medtronic notes the study, published on March 15 in Gastroenterology, the official medical journal of the American Gastroenterological Association, found that the use of GI Genius in conjunction with colonoscopy significantly decreases the miss rate (2x) of colorectal polyps and adenomas compared to standard colonoscopy.
Instylla First-In-Human Clinical Trial Published Results
Instylla notes prospective multicenter study evaluated the safety and efficacy of a PEG-based liquid embolic in treating hypervascular tumors.
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.