Appendix C. Maximum Orbit And Resulting Lumen Diameter - Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual

Appendix C. Maximum Orbit and Resulting Lumen Diameter

The following tables show the maximum orbit and resulting lumen diameter for all crown sizes, at
incremental rotational speeds, for 20 passes (approximately 5 min of treatment time). Quantitative
angiography is recommended to determine minimum vessel diameter.
Note: A pass is defined as once out and back across the lesion. Orbit data presented are based on
a 6 cm pass distance at a travel rate of 10 mm per second.
Table C1. Micro Crown Size and Rotational Speed
Model Number
DBP-EX-125MIC145
DBP-CART-125MIC145
DBP-EX-125MIC75
DBP-CART-125MIC75
SD = standard deviation
* These lumens are based on in vitro test results at approximately 5 minutes of treatment time (20 passes) at a rate of
approximately 10 mm per second of travel speed. Actual clinical results may vary.
Table C2. Solid Crown Size and Rotational Speed
Model Number
DBP-EX-125SOL75
DBP-CART-125SOL75
DBP-EX-125SOL145
DBP-CART-125SOL145
DBP-EX-150SOL145
DBP-CART-150SOL145
DBP-EX-200SOL145
DBP-CART-200SOL145
DBP-EX-125SOL200
DBP-CART-125SOL200
DBP-EX-150SOL200
DBP-CART-150SOL200
Crown Size Rotational Speed
(mm)
1.25
1.25
Crown Size (mm)
1.25
1.25
1.50
2.00
1.25
1.50
47
Max. Lumen
(rpm) Diameter* (mm)
Average +2 SD
60,000
90,000
140,000
60,000
90,000
140,000
Rotational Speed
(rpm)
60,000
90,000
140,000
60,000
90,000
120,000
60,000
90,000
120,000
60,000
90,000
120,000
60,000
90,000
120,000
60,000
90,000
120,000
1.66
1.73
1.81
1.68
1.85
2.10
Max. Lumen
Diameter* (mm)
Average +2 SD
1.95
2.51
3.69
1.89
2.37
2.95
2.05
2.90
3.91
3.18
4.36
6.05
1.97
2.33
2.86
2.44
2.98
3.86