Self-expandable Nitinol stent for cardiovascular applications: canine and human experience.

The initial experimental and clinical experience with the cardiovascular self-expandable Nitinol stent (vascular and coronary versions) is described. The stent is designed as a helical coil with two terminal balls that are used for restraining it on the delivery catheter. Upon release, the stent self-expands immediately. A temporary stent version continues with a long wire that can be removed by pulling it as a straight wire through a small profile catheter. The stent uncoils in its own groove upon removal, a relatively atraumatic procedure. The stents have been studied in dogs and in peripheral arteries in patients. The results show a transient nonocclusive proliferative response to the stent that is maximal at 3-6 mo. The removability of the permanent stent has been proven in dogs. The preliminary results in patients are encouraging and demonstrate its feasibility for permanent and potentially temporary arterial support.