HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
FX Solutions, SAS. [FX Shoulder, Inc.] Completes Easytech Reversed® Stemless IDE Enrollment in the USA
"This is not only a major milestone for FX, but for the next generation of stemless shoulder arthroplasty and the way we think about reverse total shoulder arthroplasty. As a small company, we are excited and humbled to lead the way and be the first to complete this historic study that may bring a novel device to the U.S. market which has already seen over 2000 implanted in Europe since 2015," said Baptiste Martin, CEO of FX Shoulder USA.
NEJM: New Data on COVID-19 Lung Transplants
The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.
Preclinical Study Provides Guidance for Optimizing Safety and Efficacy of Endovascular Hepatic Denervation Devices to Treat Diabetes
“This study leveraged our deep experience in preclinical evaluation of denervation therapies and could not have been performed in a timely manner without the digital morphometry techniques we developed in-house. We remain excited about the potential of neuromodulation technologies and are committed to supporting further innovation in this space,” explained Rami Tzafriri, PhD, lead author and Director of Research and Innovation at CBSET.
Checkpoint Surgical Enrolls First Patient in Nerve Regeneration Clinical Study
The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial.
Real-World Evidence Study Demonstrates Intersect ENT’s PROPEL Sinus Implant Reduces Healthcare Resource Utilization
Patients receiving PROPEL® following endoscopic sinus surgery had statistically significant lower healthcare resource utilization over a postoperative period of 18 months, including all-cause otolaryngologist, ER/urgent care and outpatient visits, as well as sinus-related endoscopies
IMPRESSION Randomized Trial: Past the Halfway Mark and Progressing Rapidly
The sirolimus coated balloon thus seems to be a promising option as the Magic Touch - AVF was granted breakthrough device designation by FDA in 2019, and the IMPRESSION RCT will provide the much-needed data.
Early Feasibility Study Demonstrates Successful Use of Abiomed’s preCARDIA Technology
The study met the safety and feasibility endpoints and suggests for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF
Patient Enrollment is Complete in the DOD-Funded Study of Extracorporeal Hemopurification of Critically Ill COVID-19 Patients
“We expect the first peer-reviewed PURIFY-OBS clinical trial publication soon, now that the study has concluded. We are pleased to see these consistent and very positive results and we’re pleased to know we have helped save the lives of many critically-ill COVID-19 patients,” said ExThera Medical CEO Robert Ward.
AtriAN Medical’s Clinical Data Update on the Neural AF Multi-center Study
Pioneering cardiac autonomic pulsed field ablation (PFA) technology provides a unique option for enhancing the durability of AF ablation.