Medical device company Medi-Tate has enrolled first fifty patients in its second multi-center European study on the iTind, a novel, minimally invasive treatment for the relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), or enlarged prostate.
Medi-Tate, a medical device company focused on addressing unmet needs in the field of urology, today announced the enrollment of the first fifty patients in its second multi-center European study on the iTind, a novel, minimally invasive treatment for the relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), or enlarged prostate.
This new study is being carried out across ten sites in Italy, Germany, Spain and Greece, and will include a total of 200 patients. The study is designed to demonstrate the safety and effectiveness of the iTind System in patients of all ages, and with prostate volumes of up to 120ml.
Medi-Tate CEO Ido Kilemnik said: “Most men suffering from BPH have a prostate volume of under 75ml, and would be suitable candidates for iTind based on our clinical data and experience to date. However, about 20% of BPH patients have prostates with a volume greater than 75ml.
“This new clinical study will allow us to understand the upper prostate volume that can be effectively treated with iTind so that an even greater number of men can benefit from this exciting technology.”
About the iTind System
The CE Marked iTind System is a minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) without heating or resecting tissue, and without leaving behind a permanent implant. 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.
Source: Company Press Release