Surgical Robotics Advance: EndoQuest and Virtuoso Begin First Human Trials for Minimally Invasive Procedures
• EndoQuest Robotics has initiated its pivotal Paradigm trial for an endoluminal robotic system designed to perform endoscopic submucosal dissection for colorectal lesions through natural body openings.
• Virtuoso Surgical has successfully completed first-in-human procedures using its robotic endoscopy system with needle-sized manipulators to perform en bloc bladder tumor resections at The Chinese University of Hong Kong.
• Both robotic systems aim to address technical challenges in minimally invasive procedures, potentially reducing the need for more invasive surgeries and improving patient outcomes.
FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years
• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades.
• The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns.
• Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.
Vivistim VNS Therapy Shows Promising Real-World Outcomes in Chronic Stroke Recovery
• Real-world data from 25 chronic stroke patients demonstrates significant improvement in upper extremity function with Vivistim paired VNS therapy, showing mean FMA-UE score increase of 9.53 points.
• The FDA-approved breakthrough device proves effective even in patients averaging 3.6 years post-stroke, with successful outcomes in 22 of 25 patients completing the six-week protocol.
• Microtransponder's Vivistim therapy has gained significant adoption, now utilized by 20% of Joint Commission Comprehensive Stroke Centers and 50% of top neuro and spine programs.
EndoQuest Robotics Receives FDA IDE Approval for Flexible Robotic Colorectal Surgery System
• EndoQuest Robotics secured FDA approval for its Investigational Device Exemption (IDE) to initiate a pivotal clinical study of its Endoluminal Surgical (ELS) System.
• The PARADIGM study will assess the safety and efficacy of the ELS system in robotic endoscopic submucosal dissection (ESD) for removing colorectal lesions across five U.S. sites.
• Pre-clinical data suggests the ELS System offers superior outcomes, a shorter learning curve, and reduced procedure time compared to conventional techniques for colorectal lesion removal.
• The ELS system aims to transform minimally invasive surgery by utilizing natural orifices or single incisions, potentially avoiding more invasive procedures like colectomies.
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