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News Release - December 11, 2018
Boston Scientific Prevails in U.S. Edwards Lifesciences LitigationDelaware Court Rules Edwards Lifesciences Infringes Boston Scientific Patent
MARLBOROUGH, Mass., Dec. 11, 2018 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX) today announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3™ Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
The jury also found that the Boston Scientific LOTUS™ Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
"We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific.
The LOTUS system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality.i,ii,iii The company anticipates the LOTUS™ Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending FDA regulatory approval timelines.
The LOTUS valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the ACURATE neo™ Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the ACURATE neo2™, which it intends to commercialize during the first half of 2019.
The LOTUS Edge Aortic valve system is an investigational device in the U.S. and is not available for sale. It is pending CE Mark.
The ACURATE neo™ and ACURATE neo2™ Aortic Valve Systems are not available for use or sale in the US. The LOTUS 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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i Kodali SK et al. Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med 2012; 366:1686-1695
ii Tamburino C et al. Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis. Circ. 2011;123:299.
iii Abdel-Wahab M et al. Aortic Regurgitation After Transcatheter Aortic Valve Implantation: Incidence and Early Outcome. Results from the German Transcatheter Aortic Valve Implantation Registry. Heart 2011;97:899-906.
Source: Boston Scientific
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