Pre-Clinical Program
GLP Animal Study to Assess Basic Safety
Diseased Cadaver Hearts Utilized to Finalize Design and Demonstrate Device Capability
- 76 fresh frozen (non fixed) cadaver hearts utilized to date
- Hearts from donors with documented medical history of coronary artery disease
- Procedures designed to replicate normal interventional procedure
- Performed in fully functional fluoroscopic animal lab
- Cadaveric aortas cannulated with glass aortic arch and descending section designed to simulate complete geometry of femoral artery stick to aorta
- System pressurized to typical arterial pressures
- Multiple variations tested - including locations in all major vessels (LAD, RCA, LCX), various arterial diameters, areas of tortuosity, differing lesion morphology and multiple interventional operators
- Upon design completion, a series of 10 cadaver heart procedures were performed with interventional cardiologists. In all 10 cases, true lumen re-entry distal to the CTO was achieved without arterial perforation.
Final Results Support Readiness for First In Man Investigation