Edwards Lifesciences outlined its strategy for longer term growth, providing an update on its technology pipeline and share its financial guidance for 2016, during its annual investor conference today. It announced a structured investment in Harpoon Medical, which is pioneering a beating-heart, transcatheter therapy for minimally invasive surgical repair of a degenerative mitral valve.
At the conference, Edward Lifesciences also reported that a US early feasibility study of the CardiAQ-Edwards transcatheter mitral valve replacement technology is expected to commence shortly, and a CE mark study should begin in mid-2016. Further product enhancements to this platform are also in development.
Additionally, the company has said it continues to anticipate a late 2016 approval for its transcatheter aortic valve implantation (TAVI) device Sapien 3 to treat intermediate-risk patients in the US with a minimal contribution to sales in the year. Based on expanded indications and the significant number of still untreated patients suffering from severe aortic stenosis, Edwards now estimates the global TAVI opportunity will exceed US$5 billion in 2021. The company expects to generate transcatheter heart valve sales of US$1.2 billion to US$1.4 billion in 2016, representing a 10% to 18% underlying growth rate, even as competition intensifies.
Michael A Mussallem, chairman and chief executive officer of Edwards Lifesciences, says: “We expect another year of strong performance for Edwards Lifesciences in 2016 led by growth in Sapien 3 valve sales and continued leadership in our core businesses. Despite foreign exchange headwinds, we are projecting solid financial results next year while we continue to invest aggressively to provide breakthrough therapies for patients in need.”