COLUMBUS, Ohio-OhioHealth interventional cardiologist Mitchell J. Silver, DO, recently performed Ohio’s first coronary atherectomy using the Diamondback 360® Coronary Orbital Atherectomy System, a vessel preparation treatment for severely calcified coronary lesions developed by Cardiovascular Systems, Inc. and FDA-cleared late last year.

 “This is an exciting new device that allows us to safely remove calcified lesions in coronary arteries before stent deployment,” said Dr. Silver, who performed the procedure with good initial results at OhioHealth Riverside Methodist Hospital. “Calcification in the coronary arteries is difficult to treat and translates into higher-risk stent procedures. This system enables us to increase our procedural safety while ensuring optimal stent deployment in these high-risk patients.”

Coronary artery disease is the leading cause of death for both men and women in the United States. It’s a condition that occurs when the arteries that supply oxygen-rich blood and nutrients to the heart muscle become narrowed or blocked by a gradual build-up of plaque, which is made up of fatty deposits, white blood cells, calcium, and scar tissue that collect in the coronary artery wall.

Calcified arterial plaque is a sign of advanced coronary artery disease and reduces the effectiveness of traditional treatments like angioplasty. Angioplasty involves temporarily inserting and inflating a tiny balloon where the artery is clogged to help widen the artery followed by the placement of a small wire mesh tube called a stent to help prop the artery open and decrease its chance of narrowing again. Because calcified plaque can be as hard as bones and teeth, angioplasty cannot effectively widen clogged arteries when calcified lesions are present.

The Diamondback system uses an electrically driven diamond-coated crown to reduce the calcified lesions, widen the artery and enable successful stent deployment.

The FDA granted approval for use of the Diamondback System on October 21, 2013. The 30-day data from CSI’s ORBIT II clinical study demonstrated that the Diamondback 360 Coronary Orbital Atherectomy System technology produced clinical outcomes that exceeded the trial’s two primary endpoints (safety and efficacy) by a significant margin.

At 30 days, ORBIT II results showed patient freedom from major adverse cardiac events was 89.8 percent and procedural success was 89.1 percent. Excluding in-hospital events, procedural success was 98.6 percent with 97.7 percent of stents successfully delivered. Moreover, 92.8 percent of patients were free from severe angiographic complications, and core lab assessed final procedure residual stenosis was 4.7 percent.