The deal for CardiAQ Valve, which like Edwards is based in Irvine, Calif., included an up-front payment of $350 million in cash and another $50 million pegged to “achievement of a European regulatory milestone,” Edwards said.
Edwards is also pursuing its own TMVI program, built on the Fortis platform. When it announced the CardiAQ Valve deal last month, the company said it also reached a deal with the investigators in its Fortis trial for changes to study’s protocol, after blood clots in some of the 20 patients implanted with the device prompted a temporary halt for the trial in May.
“We look forward to the CardiAQ team joining Edwards. We believe the combined knowledge and efforts of the talented CardiAQ and Fortis transcatheter mitral valve system teams will help us advance a therapy that offers a meaningful solution for patients,” chairman & CEO Michael Mussallem said yesterday in prepared remarks.
In April, CardiAQ won an investigational device exemption from the FDA for a 20-patient feasibility trial of its as-yet-unnamed TMVI candidate, with a protocol calling for 10 subjects to be treated transfemorally and another 10 treated via the transapical approach.