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Benzinga
Benzinga
Health
Vandana Singh

Cardiovascular Systems, OrbusNeich Scores FDA Approval For Scoreflex Scoring Balloon

FDA

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.
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