In 1991, Edwards began marketing the original Edwards Prima Stentless Bioprosthesis (Model 2500) in Europe. In the spring of 1996, a modified version was introduced. Our latest version, the Edwards Prima Plus Stentless Bioprosthesis (Model 2500P) was introduced in Europe in early 1998. The Edwards Prima Plus Stentless Bioprosthesis began clinical trials in the U.S. in 1998 and was approved for use in the U.S. in 2001.
The Edwards Prima Plus Stentless Bioprosthesis (Model 2500P) is a pig aortic valve. The valve is essentially a preserved pig’s aortic root with features that help make the valve easier for surgeons to implant. Woven polyester cloth is sewn around the inflow opening to give additional support.