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

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today, along with OrbusNeich Medical Company Ltd (OrbusNeich®), announced FDA PMA approval 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 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.

ClinicalTrials.gov Identifier: NCT03763747

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, significant arterial calcium is present in about 38 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).

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