4 results
Evaluate the safety and performance of the Virtue* Sirolimus Eluting Balloon for the treatment of in-stent restenosis (ISR) in native coronary arteries.
The primary objective of this randomized trial is to assess the Safety and efficacy of the Genous Bio-engineered R Stent* pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent* pre-dilated with non drug…
* Confirm device safety and performance* Confirm implant procedure and therapy adjustment procedure safety and performance
To investigate the effect of superior capsular reconstruction in patients with an irreparable degenerative rotator cuff tear on pain and function. Secondary, complications will be monitored and radiographic analyses performed as safety measures.