Health Problem: Coronary artery disease (CAD) is responsible for serious health effects, including myocardial infarction (MI) and death. Even in asymptomatic patients, CAD may be heralded by atherosclerosis, the thickening and hardening of arteries due to plaque buildup. Atherosclerosis results from the accumulation of fatty deposits and cell products, including calcium and other crystalized materials. Over time, atherosclerosis in the vessels that supply blood to the heart can prevent the heart from receiving enough oxygenated blood, causing CAD.

Technology Description: The Diamondback 360 Coronary Orbital Atherectomy System (OAS) has Food and Drug Administration approval for the treatment of de novo severely calcified coronary lesions prior to percutaneous transluminal coronary angioplasty or stenting. The sanding function of the single-use device is a 1.25 millimeter (mm) eccentrically mounted crown that is coated with 30-micrometer diamonds. The crown rotates along the axis of the drive shaft and orbits along the vessel walls, ablating calcified plaque and leaving the healthy vessel wall tissue unharmed.

Controversy: Calcified vessel preparation prior to stent implantation is typically performed using either balloon angioplasty or rotational atherectomy. Treatment of severely calcified coronary lesions with percutaneous coronary intervention using balloon angioplasty is associated with an increased rate of restenosis, target vessel revascularization, vessel dissection during the procedure, stent delivery failure, balloon ruptures, and undilatable lesions.

Key Questions:

  • Is the Diamondback 360 Coronary OAS effective in debulking coronary artery calcification to facilitate implantation of cardiac stents in patients with CAD?
  • How does the Diamondback 360 Coronary OAS compare with other methods to prepare calcified arteries for implantation of cardiac stents?
  • Is the Diamondback 360 Coronary OAS safe?
  • Have definitive patient selection criteria been identified for the Diamondback 360 Coronary OAS?

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