Friday, December 2, 2022

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

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.

Cardiovascular Systems President and Chief Executive Officer Scott Ward 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.”

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