This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: DIAMONDBACK 360® Coronary Orbital Atherectomy System
PMA Applicant: Cardiovascular Systems, Inc.
Address: 651 Campus Drive, St. Paul, MN 55112
Approval Date: October 21, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130005a.pdf
What is it? The Cardiovascular Systems, Inc. (CSI) DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) is a device used for the treatment of a severely calcified narrowing of a coronary artery (that is, a lesion). The OAS is a percutaneous orbital atherectomy system intended to facilitate stent delivery. The System is used in patients with coronary artery disease (CAD) who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting due to severely calcified coronary artery lesions that have not been previously treated.
The system consists of a hand-held CSI DIAMONDBACK 360® Coronary Orbital Atherectomy Device, the CSI Saline Infusion Pump, the CSI ViperWire Advance Coronary Guide Wire, and the CSI ViperSlide Lubricant.
How does it work?
- A catheter with a diamond-coated crown mounted on the end is inserted into a blood vessel in the groin or arm and advanced into a coronary artery.
- The catheter is then positioned at the narrowed portion of the artery and the diamond-coated crown is rotated. As the crown continues to rotate, it reduces the material that has caused narrowing of the artery (a procedure known as orbital atherectomy).
- The catheter is then removed from the artery and a stent can then be placed at the site of the coronary artery narrowing.
When is it used? The DIAMONDBACK 360® Coronary Orbital Atherectomy System is used in patients who have a narrowing in their coronary arteries caused by coronary artery disease – a condition that occurs when the arteries that supply oxygen-rich blood and nutrients to the heart muscle become narrowed or blocked by a gradual build-up of "plaque." Plaque is made up of fatty deposits (cholesterol), white blood cells, calcium, and scar tissue that collect over time in the coronary artery wall. If these arteries become blocked or narrowed, treatment may be required to improve blood flow and increase the supply of oxygen to the heart.
The DIAMONDBACK 360® Coronary Orbital Atherectomy System is intended to be used on plaques that have a great deal of calcium (severely calcified lesions).
What will it accomplish? A significantly narrowed coronary artery limits blood flow to the heart muscle and can cause chest pain (angina). Use of the DIAMONDBACK 360® Coronary Orbital Atherectomy System to facilitate the delivery of a stent within the narrowed coronary artery improves blood flow.
When should it not be used? The DIAMONDBACK 360® Coronary Orbital Atherectomy 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.
- Women who are pregnant or children.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.