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FDA clears Caldera’s new generation of Vertessa Lite for sacrocolpopexy procedures

Caldera Medical has received clearance from the US Food and Drug Administration (FDA) for new generation of Vertessa Lite polypropylene mesh for sacrocolpopexy.

The company claims that the new Vertessa Lite, which weighs just 20.9 g/m², is 31% stronger than the market-leading mesh with a suture pull-out strength that is 32% higher.

The new Vertessa Lite, which features larger pores of about 1500 microns, will be avaialble in Y-mesh, flat mesh sheets and mesh strips configurations.

Caldera said pelvic organ prolapse results in the bulge or herniate of one or more pelvic organs into or out of the vagina.

Various studies have revealed that 40% of women have some form of prolapse and it is projected that about 250,000 surgical procedures are undertaken a year for treating pelvic organ prolapse.

Under a sacrocolpopexy procedure, the vagina will be restored to its normal position to correct the prolapse of the vaginal vault in women who earlier had hysterectomy.

Caldera Medical CEO Bryon Merade said: "As part of our continuous product development efforts we are excited to announce the launch of a new generation of Vertessa Lite.

"Our mission is to improve the quality of life for women and every day we work towards that goal. I am proud to say that we took another step forward with our new Vertessa Lite mesh for sacrocolpopexy, which will improve the quality of life for women suffering from Pelvic Organ Prolapse."