The '550 patent was the only Edwards patent that Boston Scientific was found to infringe in the March 2017 German District Court litigation between the companies and is also the sole basis of Edwards' infringement action against Boston Scientific in Ireland. While Edwards has the right to appeal the EPO's decision, Boston Scientific believes the Edwards patent revocation will have a positive impact on both suits. As to the Boston Scientific patents that Edwards was found to infringe in March 2017—EP 2 749 254 B1 ('254) and EP 2 926 766 B1 ('766)—the German Court of Appeal will hear arguments in May and June of this year.
Following last month's U.K. Court of Appeal's decision confirming that Edwards' Sapien 3 device infringes the Boston Scientific '766 patent and that all claims of that patent are valid, the U.K. High Court has scheduled a hearing for the week of May 14, 2018 to determine what, if any, exception or limitation should be made to allow for Edwards to continue to supply the Sapien 3 valve in the U.K.
Boston Scientific currently offers the ACURATE neo Transcatheter Aortic Valve System in key European markets. The company is also seeking CE mark application for the next-generation transcatheter aortic valve implantation (TAVI) system, the ACURATE neo2, and intends to commercialize the new valve later this year as well as begin a pivotal clinical study for U.S. regulatory filing.
The ACURATE family of valve products is one of two TAVI valve systems in the Boston Scientific structural heart portfolio. The LOTUS Valve System features an adaptive seal, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality.1,2,3 The company continues to have a goal to return the LOTUS Valve to the European market and launch in the U.S. in 2019, pending its ability to clear certain technical and regulatory hurdles.
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 Valve System is currently not available for use or sale.
1Kodali SK et al. Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med 2012; 366:1686-1695
2Tamburino 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.
3Abdel-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.