El mentor recibe la aprobación del FDA para el nuevo acoplamiento del sintético de NovaSilk

por Michael Johns, Project Manager | April 24, 2006
Mentor receives FDA approval
for NovaSilk
Mentor Corporation has received U.S. Food and Drug Administration approval to market its NovaSilk(TM) synthetic mesh product used in the treatment of pelvic organ prolapse in the United States.

"Treating prolapse with grafts and synthetic mesh is increasingly being adopted by the physician community, as more clinical data indicates higher failure rates for previous (tissue plication) procedures. NovaSilk is a very nice addition to Mentor's product portfolio and offers a macroporous, knitted, monofilament polypropylene mesh, while also being soft and light," said Edward J. Stanford, MD, FACS.

Pelvic organ prolapse occurs when the pelvic floor muscles become weak or damaged and can no longer support the pelvic organs. The condition is estimated to afflict as many as 40% of women over the age of 50 years, representing approximately 36 million women in the U.S. and Europe. While prolapse is not considered a life threatening condition, it may cause a great deal of discomfort, distress and embarrassment. The use of synthetic meshes for the treatment of pelvic organ prolapse represents one of the fastest growing segments of the women's health market.

"The addition of NovaSilk to Mentor's expanding portfolio of women's health products for pelvic organ prolapse or stress urinary incontinence reinforces the commitment of our urology franchise to surgeons and the patients they serve by
providing high quality product offerings and customer service and support," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation.

NovaSilk is a soft and lightweight mesh comprised of a knitted, monofilament polypropylene. NovaSilk is Mentor's first synthetic mesh product for the treatment of pelvic organ prolapse. The Company also markets its human tissue-based Axis(TM) and Suspend(TM) products for the treatment of pelvic organ prolapse.

About NovaSilk(TM)

NovaSilk(TM) is a soft and lightweight mesh that is comprised of a knitted, monofilament polypropylene. NovaSilk offers resistance to traction, allows tissue colonization and facilitates positioning during surgery. It can be used for a variety of pelvic floor procedures, including cystocele, enterocele, rectocele and vaginal vault prolapse procedures.

About Mentor Corporation

Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com.

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