Benzinga | Jan 20, 2022 08:51AM EST

Cardiovascular Systems, OrbusNeich Scores FDA Approval For Scoreflex Scoring Balloon

Cardiovascular Systems Inc (NASDAQ: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.