Caldera Medical wins FDA 510(k) for next-gen Vertessa Lite mesh

Caldera Medical said today it won FDA 510(k) clearance for its next-generation Vertessa Lite polypropylene mesh for treating pelvic organ prolapse.

The new version of the mesh is lighter, 31% stronger than other market-leading meshes and has a 32% increased suture pull out strength, the Agoura Hills, Calif.-based company 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,” CEO Bryon Merade said in a press release.

Forty percent of women have some form of prolapse, and it is estimated that up to 250,000 surgical procedures are performed each year to treat the issue, Caldera Medical said.

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