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.
What is TULSA-PRO?
TULSA stands for
Ablation of the Prostate
TULSA treatment is a customizable, predictable and incision-free ablation of a surgeon defined region of the prostate. That means a surgeon can customize the treatment plan to specific patients and their needs. While the prostate tissue is ablated (heated to a precise temperature where cell death occurs) the system simultaneously protects the patient’s urethra and rectum to help preserve the patient’s natural functional abilities.
How is TULSA-PRO different from HIFU?
The TULSA Treatment uses/has Directional High-Intensity Ultrasound which is delivered from through the urethra. This means the energy is delivered directly through the urethra (which is being cooled throughout the treatment) to the edge of the prostate. The energy does not come through the rectum, which means the rectum is not damaged. In addition, TULSA has both rectal cooling and urethral cooling throughout the treatment to further protect the rectum from any unintended heat.
HIFU, however, uses High-Intensity Focused Ultrasound, this means the energy must pass through other tissue to reach the intended treatment location. The energy is directed through the rectum, this means the rectal wall.
Does TULSA-PRO have side effects?
As with many treatments, there are side effects associated with TULSA. The most common side effects include pain/discomfort in the treatment area, blood in urine, urinary tract infection, urinary incontinence, and erectile dysfunction. Your doctor will review with you all the risks associated with this treatment.
Has TULSA-PRO been well studied?
TULSA received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market TULSA-PRO® for ablation of prostate tissue in August of 2019. The FDA’s clearance of TULSA-PRO® was based on the Company’s TACT pivotal clinical trial, which met all of its primary and secondary efficacy and safety endpoints. TACT enrolled 115 patients across the United States, Canada and Europe with biopsy-proven, organ-confined prostate cancer (67% and 33% of subjects had NCCN intermediate and low-risk disease, respectively). All patients received primary treatment of whole-gland prostate ablation with sparing of the urethra and urinary sphincter. TACT demonstrated that the 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. The TACT study also demonstrated a favorable risk-benefit profile in the context of other ablative approaches, including whole-gland HIFU and cryotherapy.
What are the benefits?
1. Radiation free
TULSA-PRO® is a radiation-free therapy, which means it does not use ionizing radiation. TULSA uses/has High-Intensity Directional Ultrasound to ablate the prostate.
TULSA is a minimally invasive treatment and requires no incisions. Most patients recover quickly and can return to their normal activities within days.
3. Customized treatment
Your surgeon can customize your treatment based on your individual needs and disease.
TULSA treatment is performed in a single session in one day, eliminating the need for repeat treatment visits. The treatment is performed in a single session that takes a few hours. It is usually conducted under general anesthesia. After the treatment, the doctor may decide to keep the patient in the hospital overnight for observation or the patient may go home the same day.
5. Quality of life
TULSA provides comparable or better than outcomes for erectile dysfunction and urinary incontinence when compared to other prostate cancer treatment options.
6. No risk of rectal fistula
Clinical evidence has shown that neighboring organs such as the rectum are not affected by the TULSA-PRO® procedure. The system directs the ultrasound energy towards the areas of the prostate the doctor plans to treat, while also actively protecting the areas not to be treated.
Do I qualify for TULSA-PRO?
Every patient is different and there are many important factors to be taken into consideration to determine if a patient is a good candidate for TULSA-PRO treatment. Schedule a consultation to find out if you qualify.
Information and graphics courtesy of Profound Medical Corp.