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EndoQuest mentioned it’s targeted on addressing unmet wants in gastrointestinal medication and endoluminal surgical procedure. | Supply: EndoQuest Robotics
EndoQuest Robotics Inc. has submitted an Investigational System Exemption, or IDE, software for its pivotal colorectal medical research. With its versatile robotic system, the privately held medical machine firm goals to rework surgical outcomes for minimally invasive surgical procedure.
The IDE will allow EndoQuest to start its Potential Evaluation of a Robotic-Assisted System in Gastrointestinal Medication (PARADIGM) research. This can be a potential, multi-center, open-label research of the Endoluminal Surgical (ELS) System with an anticipated enrollment of fifty topics.
The corporate will conduct the PARADIGM research at 5 main U.S. healthcare services, together with Brigham and Ladies’s Hospital in Boston; Mayo Clinic in Scottsdale, Ariz.; Cleveland Clinic in Ohio; AdventHealth in Orlando, Fla.; and HCA Healthcare in Houston.
“As soon as accepted, our IDE allows the ELS System to ship to medical websites and be studied for security and efficacy,” mentioned Eduardo Fonseca, interim CEO of EndoQuest Robotics. “Whereas not but commercialized, it’s a essential step ahead and drives worth within the firm as the long run benchmark for ESD and different minimally invasive procedures.”
EndoQuest Robotics strives for minimal scarring
EndoQuest Robotics is a developer of endoluminal robotic applied sciences. The Houston-based firm designed its proprietary know-how to navigate and carry out scar-free procedures via the physique’s pure orifices.
Offering physicians with “unprecedented surgical entry, precision, and suppleness” allows a minimally invasive surgical (MIS) method, mentioned EndoQuest.
Based in 2016, the firm mentioned it has collaborated extensively with healthcare suppliers, researchers, and business companions to advance the event of its versatile robotic system. Its aim is to enhance affected person outcomes and redefine a brand new commonplace in MIS.
Surgeons to take part in PARADIGM research
As a part of the PARADIGM research, globally acknowledged gastroenterologists and colorectal surgeons will carry out robotic endoscopic submucosal dissection (ESD) procedures for the removing of colorectal lesions utilizing the ELS System. Outcomes from a pre-clinical ESD research demonstrated that the ELS System had superior procedural outcomes, a shorter studying curve, and diminished process time versus the standard method.
“There’s a vital unmet want for improved therapy of colorectal illness within the U.S.,” mentioned Dr. Todd Wilson, chief medical officer and chairman of the scientific advisory board at EndoQuest Robotics. “The robotic ESD process gives the chance to obviously show the potential advantages of our versatile robotic system by way of outcomes, issues, healthcare prices, and far more. [It] ought to finally pave the best way for the system to revolutionize a large and rising vary of different procedures throughout the globe.”
The ELS System options three key elements: the affected person cart, versatile devices, and the doctor console. With excessive mobility and maneuverability, the Affected person Cart positions the robotically managed videoscope and EndoDrive exactly the place they’re wanted for optimum entry.
The system contains a full vary of versatile surgical devices with as much as seven levels of freedom. These mimic the pure motion of the doctor’s hand providing unparalleled precision and management.
As well as, the ergonomically designed doctor console contains a digital interface that mimics the doctor’s hand motion with versatile devices contained in the affected person. This enables it to supply precision and management all through the process, mentioned EndoQuest.
The IDE submission is topic to assessment by the U.S. Meals and Drug Administration (FDA) and should be accepted previous to initiating this research. The corporate expects the assessment course of to take a minimal of 30 days.
The whole length of the assessment relies on a wide range of elements, together with the extent of potential feedback, questions, and any extra data requested by the FDA.