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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
12-Month Data Published in the American Journal of Respiratory and Critical Care Medicine, Demonstrate the Safety and Feasibility of RheOx ™ Bronchial Rheoplasty System...
The study assessed safety, changes in airway histopathology and quality of life. Performed using a minimally invasive bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System delivers non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, improving the symptoms of cough and mucus.
Concept Medical Enrolls the First Patient in the TRANSFORM-1 RCT for MagicTouch Sirolimus Coated Balloon
TRANSFORM-1 is a prospective, randomized, multi-center, European study focusing on coronary artery lesions in small vessels with a head-on comparison between sirolimus coated MagicTouch and paclitaxel-coated SeQuent Please NEO of B. Braun. 114 patients are planned to be randomized 1:1 for Magic Touch or SeQuent Please NEO.
Results of the DCLP5 Study of the International Diabetes Closed Loop Trial Published in the NEJM: t:slim Insulin Pump with Control-IQ Technolog
The DCLP5 study was the first-ever large-scale, closed-loop pediatric study that included a dedicated control group.
Pilot Study Underway to Investigate Use of Attune Medical’s ensoETM for COVID-19 Treatment
ensoETM is a single-use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for heat transfer to increase or decrease patient temperature.
New Landmark Study Published Online in Annals of Internal Medicine Show Bariatric Surgery Reduces or Eliminates Need for BP Medication in Obesity Patients in...
In the new three-year study, nearly three-quarters (73%) of gastric bypass patients were able to stop taking 30% or more of their antihypertensive medications and still maintain a blood pressure of less than 140/90 mm Hg, the study’s primary endpoint. Only 11% of those on standard medical therapy alone were able to do the same over the three-year follow-up period.
Medtronic Begins Post-Market, Real-World Study of the InterStim™ Micro System
“SNM therapy is already proven to be safe and effective, but we expect the ELITE study to definitively reinforce established SNM evidence in patients implanted with the new InterStim Micro system,” said Victor Nitti, M.D., the Shlomo Raz Chair in urology, professor of urology and obstetrics and gynecology, and chief and fellowship director of Female Pelvic Medicine and Reconstructive Surgery at the David Geffen School of Medicine at UCLA.
Aroa Biosurgery Gains Further Validation for Endoform® According to a Published Study
Aroa BioSurgery lead scientist for the study, Dr. Sandi Dempsey, said the paper describes the ability of components found within the Endoform® ECM platform technology to signal stem cells in laboratory models.
Verndari Reports: Publication in the Journal Vaccine of Early Data Using VaxiPatch™ Vaccine System to Administer Flu Vaccine Reports
“The Verndari VaxiPatch™ system holds the promise of enabling faster development of vaccines for new threats such as COVID-19 as well as more effective vaccines for existing viruses, such as influenza,” said Dr. Daniel R. Henderson, CEO of Verndari.
NovaSignal’s Lucid Robotic System Used by Mount Sinai Health System Uncovers Possible Breakthrough in Patients with Covid-19: Published in the American Journal of Respiratory...
The Lucid Robotic System integrates cerebral ultrasound, robotics, and artificial intelligence and provides physicians with cerebral blood flow data which has proven to be critical for clinical decision making and improved patient outcomes.