New Study Demonstrates Exceptional Performance With Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS) Dual Mode of Action

Rhea-AI Summary

Cardiovascular Systems, Inc. (NASDAQ: CSII) announced results from a real-world study presented at EuroPCR 2021, focusing on the efficacy of the Diamondback 360^® Coronary Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions. The study involved 20 patients, all of whom experienced 100% lesion treatment success and showed no complications. The findings highlighted the effectiveness of the OAS in facilitating stent delivery and improving patient outcomes, indicating a potential shift in coronary intervention practices.

Positive

• 100% success rate in treating severely calcified lesions
• Zero angiographic complications reported
• Demonstrated dual mechanism of action using optical coherence tomography (OCT)
• Potential paradigm shift in treatment approach for coronary interventions

Negative

• None.

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 real-world optical coherence tomography (OCT) imaging study of coronary OAS patients were released at EuroPCR 2021.

The study conducted by Surendra Avula, MD, et al, at the University of Illinois, Chicago, was designed to assess the dual mechanism of action of orbital atherectomy. Twenty consecutive patients with severely calcified lesions identified by coronary angiography were enrolled and treated by a single operator. All patients received a prespecified treatment algorithm including at least three runs of orbital atherectomy at low speed with OCT imaging pre- and post-OAS prior to stenting.

There were no angiographic complications in any patients, including 0% dissection, 0% perforation and 0% slow flow/no reflow. Using OCT assessment post-atherectomy, 100% of treated lesions showed calcium fracture (defined as fissures, craters and/or smooth concave ablation) effecting both superficial and deep calcium. Stent delivery and subsequent stent expansion was subsequently achieved in all patients (100%).¹

Said Avula, “Orbital atherectomy is used to facilitate stent expansion in severely calcified lesions. In this small observational study we utilized OCT to demonstrate the dual mechanism of action of orbital atherectomy. We clearly observed sanding of intima and fractures of both superficial and deep calcium in the coronary tree. This strategy of peri-procedural OCT imaging in combination with lower speed orbital atherectomy is a paradigm shift in the effective treatment of the calcified coronary tree, and represents a new standard for patient outcomes and safety.”

Severe calcification in coronary lesions impedes optimal stent delivery, expansion and apposition and leads to increased procedural complications and overall inferior results. The Diamondback 360^® Coronary OAS uses a powerful dual mechanism of action to treat both superficial and deep calcium, thus restoring native vessel compliance, simplifying procedural workflow, and enhancing PCI outcomes.

Scott Ward, Chairman, President and Chief Executive Officer, said, “This study highlights the benefits of imaging to optimize vessel preparation and reinforces the efficacy of orbital atherectomy’s unique mechanism of action which both ablates and fractures calcium.”

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 30% 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.

Product Disclosure:

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.

¹ Ayat, Y, et al. Observational Study Evaluating the Efficacy of Orbital Atherectomy in Treating Calcified Coronary Lesions. Presented at EuroPCR 2021.

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FAQ

What were the results of the CSII study presented at EuroPCR 2021?

The study showed a 100% success rate in treating severely calcified lesions without any angiographic complications.

What does the Diamondback 360^® Coronary OAS do?

It is designed to facilitate stent delivery in patients with coronary artery disease by treating calcified lesions.

Who conducted the study on CSII's orbital atherectomy system?

The study was conducted by Surendra Avula, MD, and his team at the University of Illinois, Chicago.

What is the significance of the dual mechanism of action in the study?

It enhances the effectiveness of treating calcified lesions, aiding in both ablation and fracture of calcium.

Is the Diamondback 360^® OAS FDA approved?

Yes, the Diamondback 360^® Coronary OAS is FDA PMA approved.