Vituro Health Partners With Profound Medical to Offer TULSA-PRO®
August 27, 2019
BIRMINGHAM, ALABAMA, UNITED STATES, August 27, 2019 /EINPresswire.com/ — Vituro Health is pleased to announce that it has entered into an agreement with Profound Medical Corp. to make its recently U.S. Food and Drug Administration (“FDA”)-cleared TULSA-PRO®system available to Vituro Health physicians for patient use.
Vituro Health believes this will be the first time that physicians in the United States will have commercial access to this ground-breaking technology.
TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician-prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men’s functional abilities.
Profound announced on August 16, 2019, that it received 510(k) clearance from the FDA to market TULSA-PRO® for ablation of prostate tissue. The FDA’s clearance of TULSA-PRO® was based on Profound’s TACT pivotal clinical trial, which included seven U.S. sites (UCLA, Johns Hopkins, Vanderbilt University, University of Chicago, Indiana University, William Beaumont Hospital and the University of Texas Southwestern). TACT demonstrated that TULSA-PRO® provides safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and PSA reduction, and low rates of residual prostate disease. The favorable safety profile offered by the TULSA-PRO® contrasts with radical prostatectomy and radiation therapy that can leave many men with permanent erectile dysfunction, urinary incontinence, and bowel dysfunction.
“We are very excited to partner with Profound Medical to offer this state-of-the-art technology to our physicians and patients,” said Vituro Health CEO Clete Walker. “We have always envisioned new technologies coming to market that support our mission to elevate the standard of care and give patients viable alternatives for a greater quality of life.”
Vituro Health will begin treating patients with TULSA-PRO® in Sarasota, Florida with Medical Director, Dr. Stephen Scionti. Dr. Scionti is one of the nation’s leading authorities in non-invasive ablative therapies for prostate cancer. “This exciting new technology allows physicians to successfully treat a broader range of patients and substantially reduce the life-changing side effects caused by surgery and radiation,” said Dr. Scionti. “Patients should continue to be vigilant in finding physicians who work to preserve their long-term quality of life.”
“Dr. Scionti and Vituro Health are recognized leaders in the ablative technology world, so we are pleased to be partnering with them to make treatment with TULSA-PRO® immediately available to patients,” said Abbey Goodman, Profound Medical’s Director of U.S. Sales. “Together, our goal is to safely and effectively treat prostate tissue disease using a technology that also maximizes quality of life.”
About Vituro Health
Vituro Health is headquartered in Birmingham, AL, providing concierge services and new technology in partnership with leading urology physicians throughout the United States who are carefully selected based on their depth of experience, expertise and dedication to achieving the highest levels of patient outcomes.
Vituro Health provides comprehensive prostate cancer care, empowering men during all stages of their lives. Our integrated, concierge-care model encompasses total prostate health management and provides services that improve the quality of life for men who are focused on prostate health. From partnering in choosing the right physician, navigating the diagnostic process to ensure a personalized plan to assisting each patient with appointments, necessary travel and making each patient a priority.
To see our official press release, click HERE