FDA Approves Coronary Indication for Cardiovascular System Orbital Atherectomy System

Diamondback 360 system approved to treat severely calcified coronary lesions

 

October 23, 2013
atherectomy cath lab fda diamondback 360 coronary orbital system CSI
The FDA recently approved Cardiovascular Systems’ Diamondback 360 Coronary Orbital Artherectomy System to treat severely calcified lesions in coronary arteries.

The FDA-approved Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a treatment for severely calcified coronary arteries. At 30 days, ORBIT II results showed patient freedom from major adverse cardiac events (MACE) was 89.8 percent and procedural success was 89.1 percent. Excluding in-hospital MACE, 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. The Diamondback 360 Coronary OAS uses an electrically driven 1.25 mm diamond-coated crown to safely reduce calcified lesions in coronary blood vessels. This ultimately helps enable successful stent deployment, which facilitates more favorable patient outcomes. For more information: www.csi360.com

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