FDA Clears Diamondback 360 Coronary Orbital Atherectomy System
November 7, 2013
November 7, 2013 — The U.S. Food and Drug Administration (FDA) approved Cardiovascular Systems Inc.’s Diamondback 360 Coronary Orbital Atherectomy System (OAS) for treatment of patients with severely calcified coronary lesions and who are candidates for percutaneous transluminal coronary angioplasty (PTCA) and have previously not been treated.
The DiamondBack system consists of a CSI Saline Infusion Pump, ViperWire Advanced Guide Wire, ViperSlide Lubicant and a diamond-coated crown. It is intended to facilitate the delivery of a stent within the narrow coronary artery to improve blood flow.
The system should not be used in patients when:
- The guide wire cannot pass across the coronary lesion.
- The target lesion is within a bypass graft or stent.
- The patient is not an appropriate candidate for bypass surgery, angioplasty or atherectomy therapy.
- The patient has angiographic evidence of thrombus.
- The patient has only one open vessel.
- The patient has angiographic evidence of significant dissection at the treatment site.
- The patient is a child or pregnant woman.
The FDA letter can be viewed here: www.accessdata.fda.gov/cdrh_docs/pdf13/P130005a.pdf
For more information: www.csi360.com