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The InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.

The InHealth Soft Sleeve Colonoscope Splint is a disposable splint or overtube for use in colonoscopy to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. This device is a silicone tube with a soft distal tip and a proximal grip. The distal tip provides a soft, conforming and flexible tapered shape that hugs the scope and facilitates insertion. The entire splint, with the exception of the outer surface of the proximal grip, is coated with a lubricious, hydrophilic coating. This lubricious coating, when wetted, enables a smooth passage of the device along the colonoscope and of the splint through the sigmoid colon. The proximal grip is fitted with an injection port for injecting water into the inside of the splint tube to facilitate lubrication. The tip is grooved to allow flow of water from the inside diameter of the splint to the outside diameter to provide a controlled lubrication of the splint, the colonoscope, and the surrounding mucosa. The proximal grip, which is larger than the shaft, ensures that the entire tube does not pass through the anus and enter the rectum. The Soft Sleeve Splint is a non-sterile disposable device, intended for one-time use only, not intended for reuse.

The Blom-Singer Indwelling 2000 Voice Prosthesis is for voice rehabilitation following total laryngectomy where placement/replacement of the voice prosthesis is done by a clinician. The Blom-Singer Indwelling 2000 Voice Prosthesis may be placed at the time of surgery or may be placed at a later date secondary to the laryngectomy.

The design of the Blom-Singer Indwelling 2000 Voice Prosthesis is substantially equivalent to the current Blom-Singer Indwelling Low Pressure Voice Prosthesis. Both devices are manufactured sterile and nonsterile, out of medical grade silicone elastomer, and are comprised of a body with an outer esophageal flange and a tracheal flange with a strap. Both devices utilize a flap valve to control the passage of air through the device. The Blom-Singer Indwelling 2000 has the addition of an assembled cartridge, consisting of a valve seat, to optimize the valve performance and longevity. The valve now has an additive which has demonstrated antibacterial properties in in-vitro studies. To aid in placing the gel cap onto the device, the esophageal flange on the outer portion of the device has been modified. The esophageal flange now has contoured areas, which allow the flange to fold along the contours for easy insertion into a gel cap for atraumatic placement of the device.