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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Preliminary Data from AAA-SHAPE to be Presented at VEITHsymposium In New York City
AAA-SHAPE is the Company’s prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
VentureMed FLEX Vessel Prep™ System 12-Month Data To Be Presented at VEITHsymposium 2022 in PAD with DCB’s and AV Access Management
These presentations will be given as part of the VEITHsymposium Annual Scientific Meeting 2022. The congress will take place in New York, New York from November 15-19th.
Surmodics Announces SWING Trial 12-Month Data to be Presented at VEITHsymposium on November 16
The session will be held on Wednesday, November 16, at the 49th Annual Symposium on Vascular and Endovascular Issues (VEITHsymposium) in New York City.
New Study Finds 85% of Aneurysms Identified by Viz™ ANEURYSM had not Been Referred for Neurovascular Review
Median size of aneurysms was 5mm, suggesting that AI-powered detection of incidental cerebral aneurysms can improve patient care pathways.
Ideal Medical Technologies Receives Approval for Second Phase of First in Man Safety Study
Ideal Medical Technologies intends to complete the first in man safety study by the end of 2022 and initiate the next safety study in ICU patients in Q1 2023. IMT is planning to bring the FUSION system to the hospital market in mid 2024.
Shanghai Operation Robot Announces the 1st Robot-assisted Human Clinical Trial of Biliary Stent Placement Surgery
Dr. Xiaofeng Zhang operated the robot outside the operating room (without wearing heavy lead), advanced the guidewire and balloon catheter in a precisely controlled manner and successfully completed the entire surgical procedure including the nipple cutter action, balloon stone removal, and accurate placement of bile duct stents.
Shockwave Confirms Consistent Outcomes for IVL in the Largest Prospective “Real World” Study of Patients with Heavily Calcified Peripheral Arterial Disease
The study represents the largest prospective “real world” evidence supporting the treatment of complex, heavily calcified peripheral arterial disease (PAD) with IVL. The final analysis was presented earlier today at VIVA22 in a late-breaking clinical trial session.
First Patient Enrolled in Reflow Medical’s DEEPER REVEAL IDE Clinical Study
The DEEPER REVEAL IDE Clinical Study is a prospective, single-arm, multicenter study that will examine the efficacy and safety of the Spur Stent for the treatment of vascular lesions in patients with critical limb ischemia
Envoy Medical Early Feasibility Study of Breakthrough Fully Implanted Cochlear Implant Now Underway
This surgery marks a key milestone for Envoy Medical on the road toward bringing the Acclaim Cochlear Implant to market. If approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant designed to be fully implanted and use the ear, rather than a microphone, to pick up sound.