Large Study Demonstrates Exceptional Safety and High Procedural Success With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS)

Rhea-AI Summary

Cardiovascular Systems, Inc. (NASDAQ: CSII) announced significant findings from a retrospective study on its orbital atherectomy system presented at TCT Connect 2020. The study involved 519 patients with severely calcified coronary lesions, achieving a procedural success rate of 100% and low complication rates, such as dissection (0.4%) and perforation (0.8%). Notably, 30-day major adverse cardiac events (MACE) occurred in just 1.3% of patients. CEO Scott Ward emphasized the study's contribution to the safety and efficacy of the system in complex cases, underscoring CSI's commitment to advancing coronary artery disease treatments.

Positive

• Study involved 519 patients with severe coronary lesions.
• Successful stent deployment in all cases (100%).
• Very low angiographic complication rates: dissection at 0.4% and perforation at 0.8%.
• 30-day MACE rate of only 1.3%, indicating high safety.

Negative

• None.

ST. PAUL, Minn.--(BUSINESS WIRE)--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, announced today that results from a large retrospective observational study of coronary orbital atherectomy were released at TCT Connect 2020.

The presentation, authored by Nirat Beohar, MD, Professor of Medicine and Vice Chief, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami, Fla., et al¹, shows exceptional safety and high procedural success in 519 patients with severely calcified cardiac disease who were treated with orbital atherectomy prior to stent deployment.

Said Beohar, “We studied over 500 patients with challenging coronary lesions. The lesions were heavily stenosed and calcified, measuring up to 60 mm in length. Over half were classified as ACC/AHA Type C lesions, the most difficult anatomy. Despite treating these most complex cases, procedural and component angiographic complication rates were all below 1% and stents were successfully deployed in all procedures. In this contemporary real-world experience, OAS was found to be safe; successfully streamlining treatment for patients with the most significant coronary disease.”

Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience

Patients	519
Percent Stenosed	86.8%
Type C Lesions	53.5%
Average Lesion Length	22.6 mm
Angiographic Complications:
Dissection	0.4%
Perforation	0.8%
Slow/No Re-flow	0.0%
Lesion Cross Rate	100.0%
Stent Delivery and Deployment	100.0%
Average Fluoroscopy Time	19.6 min.
30-Day MACE2	1.3%
30-Day Cardiac Death	0.8%
30-Day MI	0.8%

Severe calcification of coronary lesions represents a major challenge to minimize procedural complications and optimize stent delivery, expansion and apposition for best PCI outcomes. The Diamondback 360^® Coronary OAS uses a powerful dual mechanism of action to treat both superficial and deep calcium.

Scott Ward, Chairman, President and Chief Executive Officer, said, “This study expands our evidence demonstrating the safe, effective use of orbital atherectomy to treat a real-world complex patient population. With 11 studies tracking over 2200 patients to date, CSI continues to extend its leadership in the development of medical evidence for the treatment of patients with severe coronary artery disease.”

Please visit TCT Conference Hub - CSII to find information on all CSI activities at TCT Connect 2020.

¹ Orbital Atherectomy System for Treating De Novo, Severely Calcified Coronary Lesions: A Tertiary Center Experience. Authors Nirat Beohar, MD, Juan M. Vinardell, MD, Carlos Podesta, MD, Nafees Mohammed, MD, Todd Heimowitz, DO, Christian Koelbl, MD, PhD, Helen Parise, PhD, and Ajay Kirtane, MD SM.

² MACE is defined as the composite of Cardian Death, MI, ischemic CVA and hemorrhagic CVA.

About Coronary Artery Disease (CAD)

CAD is a life-threatening condition and a leading cause of death in men and women in the United States. 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 American Heart Association, 16.3 million people in the United States have been diagnosed with CAD, the most common form of heart disease. Heart disease claims more than 600,000 lives in the United States each year. According to estimates, significant arterial calcium is present in nearly 40% of patients undergoing a percutaneous coronary intervention (PCI). Significant calcium contributes 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).

About Cardiovascular Systems, Inc.

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. For additional information, please visit www.csi360.com and connect on Twitter @csi360.

Coronary Product

Indications: The Diamondback 360^® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the ViperWire^® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.

See the instructions for use for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

The Diamondback 360^® Coronary OAS is FDA PMA approved.