Cardiovascular Systems, OrbusNeich Scores FDA Approval For Scoreflex Scoring Balloon

Cardiovascular Systems Inc CSII, along with OrbusNeich Medical Company Ltd, have received FDA PMA approval for OrbusNeich's Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (Scoreflex NC).

• Scoreflex NC is a focused force PTCA scoring balloon with a dual-wire system that 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 to improve myocardial perfusion.
• Related: Cardiovascular Systems To Develop IVL Technology For Coronary, Peripheral Artery Diseases.
• A pivotal study was performed with 200 patients being treated. 
• The study results 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 coronary artery stenosis (≥70% diameter stenosis).
• Price Action: CSII shares closed at $17.73 on Wednesday.