Cardiovascular Systems and OrbusNeich this week announced that the OrbusNeich Scoreflex NC scoring percutaneous transluminal coronary angioplasty (PTCA) catheter has received FDA premarket approval.
Scoreflex NC is a force PTCA scoring balloon with a dual-wire system that creates a focal stress pattern for safe and controlled plaque modification with a lower resolution pressure, according to the companies. OrbusNeich designed the balloon for the dilation of a de novo stenotic portion of a coronary artery and in-stent restenosis in patients with coronary ischemia to improve myocardial perfusion.
“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,” OrbusNeich chairperson and CEO David Chien said in a news release. “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.”
The catheter was studied in a pivotal clinical study in the U.S. in 12 investigational sites with 200 patients treated. The results of the clinical study supported the acute safety and device success of the Scoreflex NC scoring PTCA catheter and its intended use as a dilation catheter in the stenotic part of coronary artery stenosis.
“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,” Cardiovascular Systems president and CEO Scott Ward said.