Cardiovascular Systems, Inc. along with OrbusNeich Medical Company Ltd, announced FDA PMA approval of OrbusNeich's Scoreflex®NC Scoring Percutaneous Transluminal Coronary Angioplasty Catheter. Scoreflex NC is a focused force PTCA scoring balloon with a dual-wire system which creates a focal stress pattern to facilitate safe and controlled plaque modification at lower resolution pressure. Scoreflex NC is indicated for the dilatation of a de novo stenotic portion of a coronary artery and in-stent restenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

A pivotal clinical study was performed in the U.S. in twelve investigational sites, with 200 patients being treated. The results of the Scoreflex NC - Scoring PTCA Catheter Clinical Study support the acute safety and device success of the Scoreflex NC - Scoring PTCA Catheter and its intended use as a dilatation catheter in the stenotic portion of a coronary artery stenosis (=70% diameter stenosis).