By leveraging each devicemaker’s competitive advantage, the two companies hope to increase sales in the United States, currently the world’s largest medical device market.
Terumo said it will benefit from Olympus’ marketing in the urology and gastroenterology fields and endoscope manufacture, which holds the highest market share in the United States and world. Likewise, Olympus will benefit from Terumo’s guidewire products, including those used in diagnosis and intravascular treatment.
The device makers have been developing guidewire for minimally invasive treatment devices during biliary endoscopies since 2009. The companies expect to market urologic devices soon and biliary devices later in the year, Terumo said.
Terumo will continue marketing its interventional system products in the United States for cardiology, peripheral artery disease and neurovascular disease, separately from Olympus.
For fiscal year 2016, Terumo projects more than $8.3 million in sales through the partnership.
Olympus holds an estimated 85 percent share of the U.S. market for duodenoscopes devices and other specialty endoscopes, though it may have lost some stake over its alleged role in superbug outbreaks at hospitals in Los Angeles, Calif., and Seattle, Wash., earlier this year. Lawsuits filed by patients infected by the superbug allege the Olympus scope used in their procedures (the TJF-Q180V) had a design flaw, and contends the company failed to seek appropriate U.S. Food and Drug Administration (FDA) approval for a new version that included changes which make it impossible to clean correctly, raising the risk of spreading infection.The claim says Olympus failed to validate cleaning protocols.
Olympus did not have FDA 501(k) clearance for the redesigned Q180V scope in late 2013 or 2014, the agency has said. Olympus has since filed for the approval, which is pending.
FDA officials declined to urge a voluntary recall due to Olympus’ large market share. Pentax and Fujinon make similar scopes.