ProMedica Conducts Research of Innovative Non-Invasive Treatment for Enlarged Prostate

First patient in the world completes clinical trial of the Vortx Rx® Non-invasive Image-guided Histotripsy Device for Treatment of Benign Prostatic Hyperplasia (BPH)

Released: 22-Aug-2014 8:00 AM EDT
Source Newsroom: ProMedica
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Newswise — TOLEDO, Ohio, August 22, 2014 – ProMedica is participating in innovative research into the development of a safe, non-invasive treatment for BPH or enlarged prostate. BPH can block the flow of urine out of the bladder and cause bladder, urinary tract or kidney problems. The HistoSonics, Inc. Vortx Rx device is based on histotripsy technology, a non-thermal focused ultrasound therapy that mechanically liquefies targeted tissues.

ProMedica Urologist Timothy Schuster, MD, performed the first Vortx RX experimental treatment to reduce the obstructive symptoms of BPH. It involves using high-intensity sound waves like an acoustic scalpel to break down targeted cells into a liquid that leaves the body during urination.

“Clinical trials are essential to the development of new medical technologies in order to achieve significant advancements in patient care,” Dr. Schuster said. “We are pleased to be a part of this pilot study, which is an important first step for histotripsy BPH treatment.”

More than 50% of men over the age of 50 and 80% of men 80 or older are affected by BPH. Traditional treatments for BPH include medications and standard and minimally invasive surgeries.

The Vortx RX is an investigational device and is limited by law to investigational use by qualified investigators in the U.S. and Canada.

For more information about urology services at ProMedica, visit www.promedica.org/urology.

About the Vortx RX Pilot Clinical Studies
The U.S. pilot clinical study will enroll a limited number of men with BPH symptoms at trial sites including ProMedica and the University of Michigan in Ann Arbor, Mich. The primary goal of this pilot clinical study is to demonstrate safety of the Vortx RX in the treatment of BPH.

About HistoSonics, Inc.
HistoSonics www.histosonics.com (based in Ann Arbor, Mich.) is developing Vortx RX systems to deliver histotripsy as a non-invasive, image-guided focused ultrasound therapy that mechanically homogenizes target tissue resulting in cellular destruction. Histotripsy technology was originally developed at the University of Michigan where pre-clinical research within the Departments of Biomedical Engineering and Urology has demonstrated feasibility for tissue ablation throughout the body, blood clot thrombolysis for treatment of deep vein thrombosis, cardiac tissue ablation and lithotripsy. Histotripsy technology and intellectual property have been licensed from the University of Michigan.

About ProMedica
Toledo, Ohio-based ProMedica is a mission-based, not-for-profit healthcare organization formed in 1986. ProMedica has more than 15,000 employees and nearly 1,900 physicians with more than 600 healthcare providers employed by ProMedica Physicians. Its 12 hospitals and more than 300 facilities offer comprehensive diagnostic, medical and surgical specialties in heart and vascular, oncology, orthopaedics, neurology, and women and pediatric services. ProMedica’s mission is to improve health and well-being, with a strong focus on wellness and clinical excellence, as well as innovative, community advocacy programs that address health-related issues such as hunger and obesity. For more information, please visit www.promedica.org.


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