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.”

To carry out the procedure — which can be done in a physician's office — the physician injects through a needle Macroplastique into the muscle surrounding the urethra that has “weakened over time” in a procedure that takes 15-20 minutes. The increased bulk from the agent is designed to allow the urethra to close more effectively, preventing urine from leaking during so-called “stress” activities.

Uroplasty said the approvable letter follows FDA's completion of the scientific review of the safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable, subject to the FDA's satisfactory audit of Uroplasty's manufacturing facilities, methods and controls and being in compliance with applicable Quality System Requirements.

The FDA is currently auditing the company's manufacturing facilities in Minnesota and Eindhoven, the Netherlands. Kaysen said he expects that process to take 30-60 days. If in fact, the company secures the FDA's granting of an approved PMA, Uroplasty will have to complete training and marketing programs for 60-90 days following the hoped-for final FDA approval.

At that point, Kaysen said, the company will be “ready to roll” with the product to the marketplace under the leadership of its five regional sales managers to urologists, uro-gynecologists and some gynecologists.

“Macroplastique is already a market leader and a preferred treatment outside the U.S. for SUI resulting primarily from intrinsic sphincter deficiency,” Kaysen said in a statement. “Since its introduction in Europe, over 60,000 people have been treated with Macroplastique and numerous clinical publications reinforce the safety and efficacy of this product.

Uroplasty COO Susan Hartjes Holman, said the FDA's approvable letter “moves us into the final stages of FDA approval and toward our goal to bring this exceptional product to the thousands of women in this country who can benefit from Macroplastique's proven safety and performance.”

Holman called it “an effective, non-surgical treatment for a frustrating and often embarrassing condition affecting women's lifestyle, relationships and emotional well-being.” She noted that some women have suffered from SUI even after other treatments.

SUI, the company says, is “the most common type” of urinary incontinence, affecting about 13 million Americans, of whom 85% are women. SUI is described as the sudden, accidental loss of urine during normal, everyday activities such as sneezing, coughing, laughing, straining or lifting items. Uroplasty said that 15% of the individuals with SUI suffer from a condition known as intrinsic sphincter deficiency, a “condition in which certain muscles circling the urethra weaken and can no longer properly close to hold urine.”

Although the company is requesting a PMA approval for female SUI in the U.S., in Europe it is used to treat both female and male urinary incontinence and to treat vescicoureteral reflux in children. If Macroplastique is approved for marketing in the U.S., it will offer Uroplasty's second option for SUI. Its I-STOP Mid-Urethral Sling involves a surgical procedure where polyurethane is implanted around the urethra in a minimally-invasive surgical procedure through the pelvic floor.

“It looks like a tape inserted around the urethra,” Kaysen said, noting that the sling and Macroplastique “accomplish the same goal but through different method.”

Essentially, what it gives physicians is another option.

“By having both products, we really allow the surgeon a choice of which product and which procedure is better for a particular patient,” he said.

Uroplasty's other currently approved product line in the U.S. is the Urgent PC Neuromodulation System, a minimally invasive nerve stimulation device designed for office-based treatment of overactive bladder symptoms of urge incontinence, urinary urgency and urinary frequency.