Cardiovascular Systems’ Peripheral and Coronary Data From Six Studies Presented at TCT

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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