News | Balloon Catheter | February 25, 2022

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex Scoring Balloon

Scoreflex Scoring Balloon

Scoreflex Scoring Balloon


Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich, announced FDA PMA approval of OrbusNeich’s Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

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 U.S. in twelve 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).

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, 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 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 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.”

About Scoreflex NC – Scoring PTCA Catheter Pivotal Clinical Study

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Two-hundred subjects were treated at 12 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure.

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