Cook Medical is reporting that it has received FDA’s 510(k) clearance and EU’s CE Mark of approval to market the Hercules 3 Stage Esophageal Balloon. The device is indicated for treatment of GI strictures in patients with cancer, s/p XRT, etc.
More details from the press release:
The Hercules 3 Stage Esophageal Balloon is made with proprietary P.E.T. 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. Already available as a non-wire guided balloon, Hercules has been used by clinicians to successfully treat benign and malignant strictures in the esophagus. With the addition of the wire-guided version, Cook now offers a Hercules Balloon option for the entire GI tract including the pylorus, duodenum and colon.
The preloaded wire-guided Hercules dilator facilitates the navigation of narrowed passageways. With the strongest 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.
Features from the product page:
Rapid balloon deflation is achieved with the Express Evacuation Catheter and patent-pending Rapid Deflation Sleeve™ (Based on using a 60cc Syringe) Kink-resistant Nitinol catheter provides maneuverability Flexible atraumatic tip for smooth access through especially tight strictures Excellent through-the-balloon visualization permits view of dilation progress Glow-in-the-dark size and inflation information on packaging and catheter tags for easy identification Pre-lubricated balloon facilitates removal from the accessory channel
Product page: Hercules 3 Stage Balloon Dilator …
Press release: Cook Medical’s Hercules 3 Stage Esophageal Balloon, Used to Treat Gastrointestinal Strictures, Now Available in U.S., Australia, Canada and Europe …