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HomeFDAUromedica Announces the Initiation of its FDA Investigational Device Exemption Trial for...

Uromedica Announces the Initiation of its FDA Investigational Device Exemption Trial for ACT® to Evaluate its Safety and Efficacy for RX of SUI

March 10, 2021

Uromedica notes the investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI.

The ACT protocol is a non-randomized trial expected to enroll up to 167 subjects with 12-month follow-up in which provocative pad weight test will be the primary clinical endpoint. FDA has permitted up to 11 sites in the U.S. to enroll patients. To learn more about the ACT study click here.

Michael Feloney, M.D., urologist and Chairman of the Urology Department at Creighton University in Omaha, Nebraska, performed the first ACT implantations in early February 2021. Dr. Feloney stated: “ACT offers a unique approach to the management of female stress urinary incontinence. It is exciting to be participating in this FDA trial at Creighton University Medical Center. I am confident that ACT will be similar to ProACT in providing relief for my patients suffering from stress urinary incontinence.” ProACT™, Adjustable Continence Therapy for Men, was FDA-approved in 2015 for the treatment of SUI in men after prostate surgery.

Timothy Cook, Ph.D., President and CEO of Uromedica commented: “Uromedica is very pleased to have begun our ACT trial. We are fortunate to be working with highly trained and skilled surgeons in a number of premier academic Urologic and Urogynecologic practices.“

Adjustable Continence Therapy for Women: Designed to be adjustable after implantation without further surgery, the ACT consists of two small silicone balloons connected with tubing to a filling port. The balloons are surgically placed next to the bladder and the ports are placed underneath the skin for later access and adjustment. The fluid-filled balloons provide support at the bladder neck, protecting against accidental urine leakage.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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