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Uroplasty gets approvable letter for SUI bulking agent.
Uroplasty gets approvable letter for SUI bulking agent
By KAREN YOUNG
Medical Device Daily Staff Writer
Uroplasty (Minnetonka, Minnesota) reported last week that it has received an approvable letter for its pre-market application (PMA) from the FDA for what would be the company's third product on the market in the U.S., Macroplastique Implants, one of what is known as "bulking agents" for stress urinary incontinence (SUI) in females.
It would add to its I-STOP Mid-Urethral Sling, also for SUI, it said.
"We're thrilled around here," David Kaysen, president/CEO of Uroplasty, told Medical Device Daily. "It was a long time coming. We've been selling this product in Europe for nine years. We know the sales approach . . . we understand the uses of the product."
Kaysen said the advantage of Uroplasty's bulking agent, which is a "silicone-based" gel, is that, unlike other bulking agents used for this purpose, Macroplastique "does not get absorbed in the body."
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Source: HighBeam Research, Uroplasty gets approvable letter for SUI bulking agent.