CSI Announces OrbusNeich Scoreflex NC Scoring Balloon Receives FDA Approval

January 20, 2022—Cardiovascular Systems, Inc. (CSI), along with OrbusNeich Medical Company Ltd, announced FDA approval of OrbusNeich’s Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter.

According to the company, 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. The device 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.

FDA approval was supported by results from the pivotal Scoreflex NC - Scoring PTCA Catheter Clinical Study that enrolled 200 patients at 12 sites in the United States. The single-arm, observational study demonstrated the acute safety and procedural success of the device for its intended use as a dilatation catheter in the stenotic portion of a coronary artery stenosis (≥ 70% diameter stenosis) during percutaneous coronary intervention, stated the company.

The study’s Principal Investigator was David Kandzari, MD, who is Chief of the Piedmont Heart Institute and Cardiovascular Service Line; Director, Interventional Cardiology of the Piedmont Heart Institute; and Chief Scientific Officer for Piedmont Healthcare in Atlanta, Georgia.

In the CSI press release, Dr. Kandzari commented, “The pivotal study demonstrated the effectiveness of Scoreflex NC to safely modify stenotic coronary arteries, demonstrating excellent deliverability, luminal gain, and a high rate of procedural success. Scoreflex NC will be a welcomed addition to the interventional toolbox to treat complex coronary artery disease.”