Economic Arguments Back Up Orbital Atherectomy Clinical Data, Says Manufacturer

Cardiovascular Systems, Inc. points us at one-year data and a new economic analysis from its ORBIT II coronary study in a late-breaker session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2014 conference last week.

Background

Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when plaque builds up on the walls of arteries that supply blood to the heart. The plaque deposits cause the arteries to harden and narrow (atherosclerosis), reducing blood flow, and according to estimates, significant arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention.

Getting rid of it is therefore considered a good thing, which is where Cardiovascular Systems’ Diamondback 360® Coronary Orbital Atherectomy System (OAS) comes in. Back in October 2013, the company received PMA approval from the U.S. FDA to market its system as a treatment for severely calcified coronary arteries, making it the first such device to be so-approved for over twenty years.

The company’s ORBIT II study evaluated the safety and effectiveness of the device in treating severely calcified lesions in coronary arteries. One-year data, presented at SCAI last week demonstrates freedom from target lesion revascularization and target vessel revascularization of 95 percent and 98 percent, respectively. The ORBIT II study also reported freedom from cardiac death of 97 percent.

Investigator comments

“This ORBIT II data demonstrates that the orbital atherectomy system from CSI provides one-year durable results, while giving physicians a cost effective way to address coronary calcium in these difficult-to-treat patients,” said investigator Dr. Jeffrey Chambers of the Metropolitan Heart and Vascular Institute, Minneapolis. 

Economic argument

Aside from the clinical presentation, and a departure from the norm at these events, an economist popped up to justify the device in what is a sure sign of the times. Dr. Louis Garrison, Jr., economist from the University of Washington, Seattle, presented data showing that patients treated with the Diamondback 360 Coronary OAS in the ORBIT II study have been associated with shorter hospital stays and lower retreatment rates, compared to Medicare patients treated with traditional technologies, resulting in an average lower cost of $3,200 per patient. The Medicare comparison sample was drawn from the 100 percent Standard Analytical File for the period September 2011 through December 2012. This data, presented for the first time at SCAI 2014, builds on a previous ORBIT II economic analysis by including a larger investigation of ORBIT II subjects and both outpatient and inpatient data, versus in-patient analysis only.

Company comments

David L. Martin, CSI president and chief executive officer, said: “ORBIT II results clearly show that by reducing severely calcified plaque with our technology, physicians not only reduce MACE and cardiac death rates, they also improve freedom from target vessel revascularization in this difficult-to-treat patient population, which lowers costs. This is important information for physicians, so we’re pleased that SCAI selected our data for a late breaking presentation.”

Source: Cardiovascular Systems, Inc., Business Wire

 

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