FDA Approves Cardiovascular Systems, OrbusNeich’s Scoreflex Scoring Balloon

Cardiovascular Systems Inc. (CSI) along with OrbusNeich Medical Company gained FDA premarket approval (PMA) for OrbusNeich’s Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter (Scoreflex NC).
 
The Scoreflex NC focused force PTCA scoring balloon has a dual-wire system that creates a focal stress pattern to help safe and controlled plaque modification at lower resolution pressure. It’s indicated for dilation of a de novo stenotic portion of a coronary artery and in-stent restenosis in patients with evidence of coronary ischemia in order to improve myocardial perfusion.
 
A U.S. clinical study evaluated 200 patients in the Scoreflex NC – Scoring PTCA Catheter Clinical Study supported the device’s safety and success and intended use as a dilatation catheter.
 
Dr. David Kandzari, 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, Ga., and Principal Investigator of the study, told the press, “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 U.S. 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 CEO, 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.”