Specifications

Diamondback360®CoronaryOrbitalAtherectomySystem
16

SAEs through 30 days
Subjects
N=443
Subjects
n (%)
Events
N
Cardiac death 1 (0.2%) 1
Non-cardiac death 1 (0.2%) 1
Other Disorders 5 (1.1%) 5
Any Adverse Event 91 (20.5%) 114
Table 9 and Table 10, respectively, summarize the presence and types of dissections and
perforations as assessed by the Angiographic Core Laboratory.
Table 9. Summary of Dissections at Index Procedure
Dissection
Subjects
N=443
Coronary vessel dissection present on subjects treated with OAD 52/443 (11.7%)
Type: A 9/52 (17.3%)
Type: B 22/52 (42.3%)
Type: C 8/52 (15.4%)
Type: D 4/52 (7.7%)
Type: E 1/52 (1.9%)
Type: F 1/52 (1.9%)
Type: Not Analyzable 7/443 (1.6%)
Coronary vessel dissection present on subjects not treated with OAD 1/443 (0.2%)
Non-coronary, Aortic Root dissection present on subjects treated with
OAD
2/443 (0.5%)
Non-coronary, possible Aortic Cusp dissection present on subjects
treated with OAD
1/443 (0.2%)
Table 10. Summary of Perforations at Index Procedure
Perforation
Subjects
N=443
Coronary vessel perforation present on subjects treated with OAD 8/443 (1.8%)
Type: I (fully contained) 0/8 (0.0%)
Type: II (limited extravasation) 2/8 (25.0%)
Type: III (brisk extravasation) 5/8 (62.5%)
Type: cavity spilling 0/8 (0.0%)
Type: Not Analyzable 1/8 (12.5%)
Non-coronary right ventricle vessel perforation present on subjects
treated with OAD
1/443 (0.2%)