Clinical

TIVUS I


FIM study – completed successful enrolment of 15 patient plus an additional 3 patients under compassionate use due to impaired renal function and prior stent.

Totally Number of Successfully Treated patients: 18
Confirmed Safety: No device-related complications

Confirmed Performance:
BP reduction consistent with other therapies
Positive user feedback
Reported to be less painful compared with RF technology (substantially less analgesics, site feedback)
Inherent characteristics of ultrasound allows use of less contrast
In-stent treatment is feasible


TIVUS™ II Study


Multicenter (7 sites, 25 patients) non-randomized, continuous study validating safety and performance of the Multidirectional Catheter
Three (3) concurrent registries:
Group A: Severe resistant HTN
Group B: Moderate resistant HTN
Group C: Failed prior RF therapy