Cardiovascular Systems’ Peripheral and Coronary Data From Six Studies Presented at TCT
November 09 2011 - 8:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), yesterday
presented six-month data from the COMPLIANCE 360° study of severely
calcified above-the-knee lesions at the 23rd Annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium in San
Francisco, sponsored by the Cardiovascular Research Foundation.
COMPLIANCE 360° is a prospective multi-center study which
randomized treatment 1:1 with CSI’s Diamondback 360° against
percutaneous transluminal angioplasty (PTA). Data demonstrated
that, compared to PTA alone, orbital atherectomy with low-pressure
PTA using CSI’s Diamondback 360° leads to better luminal gain by
improving lesion compliance with less need for adjunctive stenting.
Additionally, the Diamondback 360° arm required significantly less
bailout stent replacement than the PTA arm.
Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan.,
principal investigator of the COMPLIANCE 360° study noted, “The
COMPLIANCE 360° study demonstrated that orbital atherectomy is
superior to balloon angioplasty in its ability to achieve a good
angiographic result with markedly decreased need for bailout
stenting. At six months, patency in the orbital group was similar
to the balloon group, despite stents used in just 5 percent of
lesions in the orbital group versus 78 percent in the balloon
group.”
Dr. Dattilo presented the following six-month data in an oral
presentation:
Diamondback 360° Arm PTA Arm
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