Cardiovascular Systems (CSI) and OrbusNeich Medical Company have announced US Food and Drug Administration (FDA) premarket approval (PMA) of 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 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 USA in 12 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).
David Kandzari (Piedmont Heart Institute, Atlanta, USA), principal investigator of the study, said: “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.”
“We are extremely pleased to receive FDA PMA approval for our Scoreflex NC device and are delighted to introduce this scoring balloon to US physicians through our distribution partner, CSI,” said David Chien, OrbusNeich’s chairman and CEO. “In our continued commitment to delivering innovative products that can change the lives of many patients, we are confident our product will provide increased treatment options.”
Scott Ward, CSI’s chairman, president and chief executive officer, said: “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease. Scoreflex NC complements our coronary orbital atherectomy system and expands the patient population we serve.”