Promising, but still a matter of debate.

Several trials failed to demonstrate the efficacy of plaque modification device in patients with severely calcified coronary lesions. Safety and efficacy of the Diamondback 360® Coronary OAS have been demonstrated by the ORBIT II trial. The 2-year follow-up of the ORBIT II trial extends the favorable results previously shown at 30-day and 1-year follow-up. The single arm, non-randomized character of the trial with indirect historical comparison may restrict the results to hypothesis generating and entail further prospective randomized trials.