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The patient was enrolled at The Ohio State University, one of four sites actively enrolling patients in the double-blind, randomized clinical trial.
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
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.
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
“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.
Pioneering cardiac autonomic pulsed field ablation (PFA) technology provides a unique option for enhancing the durability of AF ablation.
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