Intelligent Surgical Instrument Approved by the FDA
The i60 Intelligent Surgical Instrument Device, manufactured by Power Medical Interventions, was granted marketing clearance by the FDA. Announcement of the approval was reported on Health Imaging.
The device delivers four rows of medical grade titanium staples in designated tissue at the same time that it cuts between them, this activity is completed with a simple press of a button. Device articulation mimics that of the human wrist, which supports access to difficult to reach anatomic locations.
The device is used to support multiple activities during surgery; tissue manipulation, cutting, and stapling. This is facilitated with this power-assisted endomechanical instrument. The company purports that the device offers improved control, precision, accuracy, and consistency. In addition, they suggest that the i60 provides access to anatomic sites, superior compressive force, and is easier to use.
The i60 is operated with motor control circuits, clinician-feedback technology, and drive motors. These components were miniaturized and placed within the device handpiece. The device is operated using digital controls in the device handle. Neither flexible shafts nor power consoles are required to operate the device.
The device is used in a variety of surgical applications, including both endoscopic (minimally invasive) and open approaches for gastrointestinal, general abdominal, gynecologic, and thoracic surgeries. It aids in both transection and resection, open occlusion of the left atrial appendage of the heart, and creation of anastomoses in cardiac surgeries.
October 8, 2007 Related topics: Product Approval & Certification, Bariatrics & Obesity, Quality, Safety, Errors, Surgery, Endoscopy