Cardiovascular Systems Touts Positive Results from Diamondback 360 Trial

Cardiovascular Systems Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced results from a real-world optical coherence tomography (OCT) imaging study of coronary OAS patients.
 
The study conducted by Surendra Avula, M.D., 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 percent dissection, 0 percent perforation and 0 percent 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 percent).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 CEO, 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.”
 
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).
 
The Diamondback 360 Coronary OAS is approved by the U.S. Food and Drug Administration.

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