EndoChoice wins FDA 510(k) for Orca endoscope valves, announces multi-product launches

EndoChoice said it won FDA 510(k) clearance for its Orca sterile, single-use air, water and suction valves designed for Olympus 160, 180 and 190 flexible endoscopes, and announced the launch of its 3rd-gen Fuse endoscopy system and RescueNet retrieval device.

With the clearance for the Orca valves, as well as previous regulatory wins, EndoChoice will begin sales and distribution in the U.S., European Union and other select markets, Alpharetta, Ga.-based EndoChoice said.

“EndoChoice has been dedicated to improving the standard of care for infection control since 2010, when it launched the Compliance EndoKit, the first GI procedural kit designed to help clinicians standardize to good infection control practices.  The Orca sterile single use air/water and suction valves are an excellent addition to the Compliance EndoKit, thus continuing to improve the standard of care in GI,” CEO Mark Gilreath said in a press release.

The company said that recently published guidelines from the Association for the Advancement of Medical Instrumentation and the Society of Gastroenterology Nurses and Associates indicate that reusable endoscopic accessories should be reprocessed together with the endoscope set to ensure traceability.

The disposable nature of the Orca valves allows clinicians to adhere to the reprocessing guidelines while “improving patient care and workflow efficiency,” EndoChoice said.

Earlier this month, EndoChoice said it launched its 3rd generation Fuse full spectrum endoscopy system, with commercial sales and distribution beginning in the U.S., European Union and other select markets.

The newly launched endoscope is designed to allow for enhanced views of the mucosal structures and vascular patterns in their natural colors.

“We are truly excited to bring Fuse Generation 3 and Lumos to the world of GI. With generation 3, not only do GI’s have an increased field of view to help detect lesions, they now have the ability to enhance anatomy like never before with Lumos Adaptive Matrix Imaging.  We believe these advancements take the Fuse platform to an unprecedented level in endoscopic screening,” Gilreath said in a prepared statement.

The company also launched its RescueNet retrieval polypectomy snare device.  The device incorporates the company’s ProMesh technology and is designed to allow for improved visibility and control, as well as improved mesh strength for “reliable and efficient foreign body removal.”

“This innovation is the result of our company’s unique insights into the needs of GI caregivers to provide tools which improve the efficiency and effectiveness of their clinical procedures. RescueNet is the perfect addition to our family of Rescue retrieval devices and the EndoChoice portfolio of polypectomy devices, which includes the Boa polypectomy snare, Mako biopsy forceps, Neptune injection needle, and the TrapEase polyp trap,” Gilreath said in a prepared release.

The newly cleared devices will be presented at the Digestive Disease Week meeting in San Diego, Calif. and the SGNA 43rd annual course in Seattle, Wash. this week, the company said.

Last June, EndoChoice priced its initial public offering at $15 per share, the low end of the range, raising $95.2 million for its Fuse full-spectrum endoscope.

EndoChoice shares are trading on the New York Stock Exchange under the “GI” symbol, the company said.

EndoChoice  said it planned to float 6.25 million shares at $15 to $17 each, for a midpoint raise of $100 million. The company filed confidentially last January for an IPO worth up to $115 million, scarcely 2 months after pulling down a $57 million funding round for its Fuse full-spectrum endoscope.

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