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.”
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.
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
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.