Olympus, announced today an exclusive agreement to distribute the HANAROSTENT®. Olympus has joined forces with M.I. Tech, a global leader in stents and other devices designed to improve patient quality of life. This agreement leverages company synergies in disease focus areas, while also leveraging Olympus’ robust EndoTherapy portfolio. The 510(K) cleared HANAROSTENT Biliary and HANAROSTENT Esophagus will be the first of multiple self-expanding metal stents to be rolled into the Olympus EndoTherapy portfolio for advanced procedures.

Jin-Hyung Park, CEO at M.I.Tech Co. Ltd reported, “We are confident in the hundreds of stents and other products in our portfolio that are already providing quality of life benefits to patients all over the world.”  He adds, “Olympus is an ideal partner for us because of its trusted brand in the U.S. medical space. The company’s expertise and insight with strategic introductions of devices will be invaluable. We look forward to a mutually beneficial relationship.”

“Many patients who benefit from the HANAROSTENT are faced with end-stage diagnoses,” said Kurt Heine, Group Vice President of the Endoscopy Division at Olympus America Inc. “Palliation of strictures through the HANAROSTENT can help improve their quality of life. Olympus is pleased to bring these unparalleled stents, used globally, to physicians and patients in the U.S.”

HANAROSTENT® Biliary uncovered stent and HANAROSTENT Esophageal fully covered stent are 510 (K) cleared devices made by M.I. Tech and now distributed exclusively through Olympus in the U.S. Both are used for the treatment of strictures and to improve quality of life. (Medical Device News Magazine)
HANAROSTENT® Biliary uncovered stent and HANAROSTENT Esophageal fully covered stent are 510 (K) cleared devices made by M.I. Tech and now distributed exclusively through Olympus in the U.S. Both are used for the treatment of strictures and to improve quality of life. (Medical Device News Magazine)

The 510(K) cleared uncovered biliary stent and fully-covered esophageal stent will bring clinical differentiation to the existing luminal patency market. Both stents provide:

  • A unique wire structure: hook-cross nitinol design allows for optimal radial and axial force to facilitate controlled expansion, conformability to anatomy, and segmental compression for minimized foreshortening.
  • Anti-migration benefits due to a flared-end design.
  • Precise placement: 4 unique gold radiopaque markers at the center of the stent allow for accurate placement at the middle of the stricture site, as well as an additional 8 gold radiopaque markers on the proximal and distal ends for further visualization.
  • Repositioning or recapture functions: the biliary stent can be fully recaptured, marked by a red “point of no return” on the device handle. The esophageal stent is easily repositioned with a lasso on both the proximal and distal ends.

The HANAROSTENT Biliary uncovered stent comes available in 13 different sizes, with unique lengths to more accurately target different strictures; a commonly used 6cm size, as well as new 5cm and 7cm length options. The HANAROSTENT Esophagus comes available in 8 different sizes, with 8cm and 15cm length options.

According to recent MarketsandMarkets™ research, “Gastrointestinal / GI Stent Market by Type,” the global market for stents is projected to reach USD 452.6 Million by 2022 from USD 353.4 Million in 2017, at a CAGR of 5.1% during the forecast period.i HANAROSTENT, a device with global recognition in the medical community, is the first M.I.Tech device of many slated for strategic roll-out in the U.S. through this new relationship with Olympus.

Olympus will market and sell HANAROSTENT through its existing U.S distribution networks in GI. Over time, Olympus and M.I. Tech will work together to identify an appropriate pathway for other globally significant M.I. Tech products to be taken from the regulatory process through to U.S. launch, leveraging Olympus’ established channels.

This agreement will be highlighted and HANAROSTENT stents showcased at Society of Gastroenterology Nurses and Associates (SGNA) in Orlando, FL, May 20 – 22 at booth 801 and Digestive Disease Week (DDW) in Washington, D.C., June 2-5, 2018 at booth 2833.