BlueWind Medical has reported positive results from a follow-up study of patients using its implantable tibial nerve neuromodulator for the management of overactive bladder (OAB).
Results from 36-month Optimist follow-up study show BlueWind Renova is a safe, minimally invasive system that offers durable and significant improvements for OAB patients.
BlueWind Medical conducted the study at four clinical centers in the UK and the Netherlands. It evaluated the long-term performance and safety of the RENOVA iStim in managing OAB, including urinary urge incontinence (UUI) and symptoms of urgency frequency (UF).
The study is an extension of the earlier published Optimist six-month pilot study and included 20 of the 36 pilot study patients.
The 20 patients that were present in the long-term follow-up represent the original pilot cohort based both on demographics and on clinical response.
BlueWind stated that the study showed a sustained high responder rate of more than 36 month follow-up period, comparable with response rates typical for sacral neuromodulation.
After three years of the implantation of Renova iStim device, 75% of patients are claimed to have experienced at least a 50% long-term reduction in OAB symptoms.
50% of patients experienced durable, long-term, effect of UUI relief in ‘leaks’ and 80% of patients experienced long-term, effect of UUI relief in ‘large leaks’. No severe adverse events (SAE’s) were reported throughout the follow-up study.
The study’s primary investigator John Heesakkers said: “We are very encouraged by the sustained long-term results of the RENOVA system. The study provides assurance that BlueWind’s RENOVA iStim stimulation of the tibial nerve can lead to meaningful symptoms improvement, without the clinical risks associated with sacral device implantation.”
Results from the study show that RENOVA iStim system offered long-term improvement in all health-related quality of life aspects for 70% of the patients and showed a meaningful improvement assessed by OAB quality of life questionnaire.
Rainbow Medical CEO and BlueWind Medical board chairman Efi Cohen Arazi said: “The 36-month study results confirm that the RENOVA iStim system provides robust and effective long-term performance, that could help millions of patients in the management of OAB.
“We believe BlueWind has highly differentiated wireless neuromodulation, and this data provides strong evidence of the potential for this technology in OAB and other indications.”