Medi-Tate Ltd., a medical device company focused on addressing unmet needs in the field of urology, today announced publication of the three-year follow-up data from the pilot feasibility study in the British Journal of Urology International. The study evaluated the safety and effectiveness of the TIND, the company’s prototype for the novel iTind® System, developed as a treatment for patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), or enlarged prostate.
In the publication, the authors conclude that, “This extended follow-up of the first cohort of patients undergoing TIND therapy, corroborated our previous findings, which demonstrated that the TIND procedure is safe, effective and well tolerated for at least 36 months.”
Prof. Francesco Porpiglia, lead investigator of the study and professor and chair of the Department of Urology Luigi Gonzaga University Hospital in Turin, Italy said, “The TIND, now iTind, is unique in that it is a device that performs a procedure. It offers a minimally invasive alternative for treating the symptoms of BPH that also preserves sexual function, but that does not leave behind a permanent implant.”
The study’s authors note that LUTS are some of the most common medical complaints that affect men as they age, however, many men seek more significant symptomatic improvement than those provided by medical therapy, yet are also not willing to face the risks to sexual function and urinary continence associated with surgery.
Porpiglia adds, “These results demonstrate that the TIND is a straightforward, safe and effective option that is well tolerated by patients with no procedure-related complications reported, including no cases of sexual dysfunction.” He went on to say “Many studies on the second generation and commercially available iTind are ongoing and their preliminary results are promising, suggesting that this kind of device can be included in the daily armamentarium of the urologist for the management of benign prostatic obstruction.”
“We are encouraged by these results as they demonstrate that creating incisions through pressure is not only well tolerated, but also provides significant and durable symptoms relief. We are also excited about the new clinical data soon to be published on our second generation iTind, and to witness the growing clinical adoption of the procedure and the positive impact we are able to make towards improving men’s quality of life and well-being around the world,” said Ido Kilemnik, Founder and CEO, Medi-Tate Ltd.
Results of the three-year follow-up of this first study demonstrate:
- A highly tolerable, minimally invasive procedure
- Rapid reduction of symptoms following the procedure
- Preservation of sexual function
- Sustained effect, with an IPSS (International Prostate Symptom Score) of 12, a reduction of 7 points from baseline; a Qmax (peak urinary flow rate) of 10.1ml/sec, an increase of 3ml/sec from baseline; and a QoL score of 2
- A durable treatment with only 3 patients resuming pharmaceutical therapy at 36 months.
The CE Marked iTind System is a minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The iTind, temporarily implanted nitinol cutting device, is implanted through a straightforward, minimally invasive transurethral procedure and left in place for only 5 to 7 days. While in-situ, the iTind device expands, exerting radial force on the tissue and creating ischemic incisions in the prostatic urethra and bladder neck to relieve the obstruction. After only 5 to 7 days, the procedure is complete and the device is completely removed. The iTind System is available in the Europe, Canada, and Hong Kong. Learn more at http://www.itind.com.