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EndoQuest has its sights set on fulfilling unmet needs in the realm of gastrointestinal pharmaceuticals and minimally invasive endoluminal surgery. | Supply: EndoQuest Robotics
EndoQuest Robotics Inc. The company has submitted an investigational device exemption (IDE) software for its pivotal colorectal cancer clinical trial. The privately held medical device company aims to revolutionize surgical outcomes with its cutting-edge, versatile robotic system designed specifically for minimally invasive procedures.
Will the integrated development environment enable EndoQuest to initiate its Potential Evaluation of a Robotic-Assisted Machine in Gastrointestinal Medication, PARADIGM, study?
A prospective, multicenter, open-label study is planned to evaluate the Endoluminal Surgical (ELS) System, with an estimated 50 participants.
The corporation will conduct a paradigm examination at five major United States sites? Healthcare services partner with esteemed organizations, including Brigham and Women’s Hospital in Boston, Mayo Clinic in Scottsdale, Arizona, Cleveland Clinic in Ohio, AdventHealth in Orlando, Florida, and HCA Healthcare in Houston.
“As authorized, our IDE enables the software to be shipped to scientific websites, where it can be studied for its security and efficacy,” said Eduardo Fonseca, interim CEO of EndoQuest Robotics. While not solely commercialized, this milestone represents a significant stride forward, underpinning value creation within the organization by establishing a lasting benchmark for Electrophysiology Studies (ESD) and other minimally invasive procedures.
EndoQuest Robotics pioneers minimally invasive surgical procedures.
EndoQuest Robotics is a pioneer in the field of endoluminal robotics and applied sciences. A Houston-based company has developed a proprietary approach to perform scarless surgeries through the body’s natural orifices, leveraging the individual’s inherent anatomy.
By providing surgeons with unparalleled access, accuracy, and flexibility, EndoQuest enables the adoption of minimally invasive procedures that revolutionize patient care.
By 2016, the company had collaborated intensively with healthcare providers, researchers, and industry partners to drive the development of its innovative robotic system. Its objective is to optimize patient outcomes and establish a pioneering standard in Medical Information Systems (MIS).
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Surgeons to participate in PARADIGM trial examination.
As part of the PARADIGM examine, renowned global gastroenterologists and expert colorectal surgeons will collaborate to perform robotic-assisted endoscopic submucosal dissection (ESD) procedures using the cutting-edge ELS System for the effective removal of colorectal lesions. Studies showed that the ELS System yielded significantly better procedural outcomes, accelerated learning curves, and reduced processing times compared to traditional methods.
“There’s an unmet need for better treatment options in colorectal cancer cases in the United States,” said Dr. Todd Wilson, Chief Medical Officer and Chairman of the Scientific Advisory Board at EndoQuest Robotics, “The robotic ESD process provides a unique opportunity to demonstrate the tangible benefits of our flexible robotic system through measurable outcomes, reduced costs, improved healthcare, and other key performance indicators.” “It will ultimately lay the groundwork for the system to transform a broad and increasing range of processes worldwide.”
The ELS System comprises three core components: the patient’s personalized cart, adaptable treatment devices, and a physician’s intuitive console. With unparalleled agility and dexterity, the Affected Person Cart precision-positions the robotically controlled videoscope and EndoDrive at the optimal site for seamless insertion.
The system features a comprehensive range of flexible surgical instruments boasting up to seven degrees of freedom. With precise control, these instruments perfectly replicate the smooth motion of a skilled surgeon’s hand, offering unmatched accuracy and command.
The advanced doctor’s console features an ergonomic design that accurately simulates hand movements, seamlessly integrating various medical devices to interact directly with patients. This allows for precise control and management throughout the process, as highlighted by EndoQuest.
The IDE submission is subject to evaluation by the U.S.? Prior to commencing this study, Meals and Drug Administration (FDA) approval is necessary. The corporation expects the evaluation process to take a minimum of 30 days.
The evaluation’s scope hinges on various factors, including the magnitude of potential feedback, questions, and additional information required by the FDA.