Boston Scientific Prevails in German Edwards Lifesciences Litigation

Court Rules Edwards Lifesciences' Next-Generation Valve Infringes Boston Scientific Patent and Grants Right to Enjoin Sales in Germany

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Boston Scientific Corporation

Oct 23, 2018, 06:35 ET

MARLBOROUGH, Mass., Oct. 23, 2018 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the District Court of Dusseldorf, Germany has determined that Edwards Lifesciences Corporation's Sapien 3 Ultra^™ device infringed a patent – established by Symetis SA, a subsidiary of Boston Scientific – specific to the fabric used on the valve seal, specifically the German part of European Patent (EP) 2 949 292 B1. The Dusseldorf Court ruled in preliminary injunction proceedings that Boston Scientific has the right to enjoin Edwards and its German subsidiary from offering and selling Sapien 3 Ultra in Germany. The infringement and injunction decision can be appealed by Edwards.

In 2017, Edwards' currently-available Sapien 3^™ device was found to infringe two Boston Scientific patents (EP 2 749 254 B1 and EP 2 926 766 B1) by the same Court. Those rulings, which have been appealed by Edwards, enable Boston Scientific to enjoin Sapien 3 from the German market. The company has not yet exercised that option.

"We are pleased with the steady cadence of European court rulings which uphold and validate our TAVR intellectual property against competitive encroachment," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific. "Defending our patents is a core necessity which allows us to continue to innovate and offer differentiated technologies to hospitals, physicians and their patients."

Boston Scientific currently offers the ACURATE neo^™ Transcatheter Aortic Valve System in key European markets and is seeking a CE mark for the next generation system – ACURATE neo2^™ Transcatheter Aortic Valve System – which it intends to commercialize during the first half of 2019. The company expects to begin a pivotal clinical study of the ACURATE neo2 system in the U.S. later this year.

The ACURATE family of valve products is one of two TAVI valve systems in the Boston Scientific structural heart portfolio. The Company anticipates the LOTUS™ Edge Valve System will be commercialized in CE mark countries in Q1 2019 and FDA approval to be secured in mid-2019, pending regulatory approval timelines.

The ACURATE neo™ Aortic Valve Systems are not available for use or sale in the US.
The ACURATE neo2™ Aortic Valve System is not available for use or sale.
The LOTUS Edge™ Valve System is currently not available for use or sale.

About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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SOURCE Boston Scientific Corporation