First-in-Human Clinical Study

Sell Sheet

The first-in-human clinical study was conducted to evaluate the safety and technical efficacy of the CorPath 200 System in precisely driving guidewires and stent/balloon catheters in PCI procedures:

  • Corbic Research Institute, Envigado, Colombia
  • Eight subjects enrolled

Results

  • Clinical success rate - 100%
  • Final diameter stenosis of less than 30% after delivering PCTA/stent to targeted lesion
  • No occurrences of major adverse coronary events (MACE)* at discharge and 30 day follow-up
  • Significant (97.1%) reduction in radiation exposure to the operator
  • Reduced contrast utilization compared to historical ~ 36% reduction**
* MACE defined as cardiac death, Q-wave or non Q-wave myocardial infarction, or clinically driven target vessel revascularization by percutaneous or surgical methods
** 159 ml vs 250 ml (Nikolsky E, Pucelikova T, Mehran R, et al. An evaluation of fluoroscopy time and correlation with outcomes after percutaneous coronary intervention. J Invasive Cardiol 2007; 19: 208-213).