Cook Medical has expanded its offering of line of endoscopy devices by launching Hercules 3 Stage Esophageal Balloon in the US, Australia, Canada and Europe after receiving 510(k) clearance and CE Mark certification.
The Hercules 3 Stage Esophageal Balloon is made with PET Flex technology, a new material that optimally combines the high tensile strength and flexibility necessary for a strong balloon that inflates accurately to three distinct and increasing diameters.
Hercules has been used by clinicians to treat benign and malignant strictures in the esophagus. With the addition of the wire-guided version, Cook offers a Hercules Balloon option for the entire GI tract including the pylorus, duodenum and colon.
GI strictures are treated endoscopically by passing a deflated balloon into the strictured area, inflating it to dilate the passage, and then deflating and removing the dilator. A balloon dilator can also be used to open the lumen so other procedures can be performed, such as biopsies or stent placement.
The preloaded wire-guided Hercules dilator facilitates the navigation of narrowed passageways. With the radial strength of any dilator on the market, Hercules holds its shape during dilation and inflates to three distinct and increasing diameters, reducing the need for multiple dilation procedures. Two radiopaque bands on the balloon aid in accurate fluoroscopic positioning, and glow-in-the-dark labels and unique packaging enhance ease of use.
Kevin Waschke, director of therapeutic endoscopy and endoscopic ultrasound at McGill University Health Centre in Canada, said: “Because of the two radiopaque markers, it was very easy to image the balloon for positioning. We have not experienced any difficulties to date, in any cases, regarding the strength of the balloon. We’ve noticed how convenient it was to stage accurately, and we did not need to constantly adjust the position of the balloon.
“At the conclusion of the procedure, we were able to deflate the balloon rapidly and then remove the balloon without any difficulties. In the past, other balloons could become stuck, which always required additional time and additional patient sedation.”
Barry Slowey, business unit leader at Cook Endoscopy, said: “The Hercules 3 Stage Esophageal Balloon is an expansion of the Hercules product line that brings the benefits of this technology to areas outside of the esophagus. Hercules offers the choice of either a preloaded wire-guided or a non-wire-guided balloon, improving dilation procedures and efficiencies. We’re excited to make this technology available to physicians throughout the US, Australia, Canada and Europe.”