Introducing the Diamondback 360® Coronary Orbital Atherectomy System, featuring OAS technology.

 

CSI is defining Orbital Atherectomy with the first evidence-based vessel preparation treatment for severely calcified coronary lesions, which enables successful stent deployment, leading to safe and effective PCI outcomes with low re-admission rates.

Coronary arterial calcium can cause complications when treating coronary artery disease (CAD). Diamondback 360 Coronary OAS’s unique mechanism of action uses a patented combination of differential sanding and centrifugal force to safely and simply, reduce coronary arterial calcium.

Gain greater confidence in your patients' PCI outcomes when treating severely calcified coronary lesions. Change lesion compliance to enable successful stent deployment. Low re-admission rates for PCI patients and decrease length of stay1 with the first evidence-based technology for the safe treatment of severe arterial calcium – the Diamondback 360 Coronary OAS.

 

Unique Mechanism of Action

  • Eccentrically mounted diamond-coated crown reduces coronary plaque while changing vessel compliance, enabling successful stent deployment.
  • As the crown rotates and orbit increases, centrifugal force presses the crown against the lesion, reducing arterial calcium.
  • Differential sanding allows healthy tissue to flex away.
  • Miniscule particulates produced don’t require embolic protection.
  • Effective in a wide range of coronary vessel diameters.
  • Continuous blood flow while orbiting minimizes the risk of thermal injury to the vessel.

 

Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Contraindications: The OAS is contraindicated when the ViperWire® guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated.

See the instructions for use before performing Diamondback 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events.  

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

 

Click here to access the full brief statement.

 


1. Market Opportunity and Pricing for CSI’s Coronary Atherectomy Device, Navigant. Sept 4, 2013.