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

IN.PACT AV Drug-Coated Balloon Is First and Only to Show Superior and Sustained Results Through Two Years Compared to PTA in Treating Arteriovenous Fistulae Lesions

The data, which were presented virtually as a podium first at the 2021 Charing Cross Symposium, demonstrated that the IN.PACT™ AV drug-coated balloon (DCB) is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal angioplasty (PTA) in end-stage renal disease (ESRD) patients with de novo or non-stented restenotic native arteriovenous fistulae (AVF) in the upper extremity.

Martell Diagnostic Laboratories Announces HERTEST: Groundbreaking Way to Detect Effectiveness of Breast Cancer RX Globally

HERTEST is a blood test that looks for a protein called human epidermal growth factor receptor (HER2), which is shed into the blood stream of patients with growing breast cancer tumors.

ESPRIT CAM Improves Productivity for Long Part Machining by Automating Multi-spindle Program Creation

ESPRIT CAM: New computer-aided-manufacturing (CAM) technology has been introduced by ESPRIT CAM, part of Hexagon’s Manufacturing Intelligence division that provides manufacturers with the control and flexibility needed to use multi-spindle and multi-channel computer-numerical-control (CNC) machinery for the machining of long parts.

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.

spot_img

DON'T MISS

Related Articles