Olympus today announced positive study data for its minimally invasive iTind treatment for symptoms of enlarged prostate.
The iTind procedure involves the placement of a temporary implanted nitinol device that reshapes the prostatic urethra. It does this without burning or cutting the prostate. Device placement can occur in an outpatient setting or physician’s office.
The Olympus device remains in place for five to seven days while the patient stays at home. Upon removal, patients experience rapid and effective relief of their symptoms. Olympus acquired iTind when it acquired Medi-Tate, now a wholly-owned subsidiary, in May 2021.
It offers an alternative to pharmaceutical therapy, surgeries and permanent implants. Olympus said it’s proven to relieve symptoms without affecting sexual and ejaculatory function or urinary continence.
Results from a long-term study showed long-lasting relief of more than four years for people with an enlarged prostate (BPH). iTind led to significant and durable reduction of BPH-related lower urinary tract symptoms. It also led to improved International Prostate Symptom Scores (IPSS) and quality of life. The study found this impact across more than 50 months and up to 79 months (6.6 years) post-treatment.
“This evidence of clinical durability is important to physicians considering surgical options for BPH symptom treatment,” said Dr. Daniele Amparore in the Division of Urology at San Luigi Hospital in Orbassano, Italy, who is a co-leading author of the study. “We now have published study data showing iTind device treatment is a reliable minimally invasive surgical option with minimal safety concerns for extended time periods.”
Breaking down the results from the Olympus study
Fifty patients comprised the prospective, single-arm, multicenter study beyond 36 months following treatment. The study analyzes results for 41 of the 50 patients at 50-79 months following treatment. Nine patients were unavailable for follow-up and five patients were lost to follow-up. Two patients died in a manner unrelated to iTind placement. The remaining two patients (36–48 months follow-up) required surgical re-treatments (one transurethral resection of prostate, and one thulium laser enucleation of prostate).
iTind demonstrated significant improvement in symptoms, with IPSS reducing by 45.3%. Olympus reported no late post-operative complications beyond 36 months of follow-up. No patients required additional medication.
Surgical re-treatment rate after 36 months came in at 4%. The total cumulative re-treatment rate from baseline to 79 months totaled 11.1%.
“We are very excited to see positive results from the study follow-up showing that treatment with the iTind procedure is safe, effective and long-lasting,” said Vanessa Malka, executive director and iTind commercial head for Olympus Corp. “This is very important evidence for urologists and their male patients who are considering treatment with the iTind procedure as an alternative to current BPH therapies, as it proves the iTind procedure contributes to positive patient outcomes over a long period of time.”