Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
12
Vessel calcification, as determined by the Investigator, is reported in Table 3. The
overall mean length of calcium treated was 28.6 ± 0.8mm, ranging from 9.0 – 100 mm.
Table 3. Vessel Calcification
Characteristic
Subjects
N=440
Subjects with calcification determined by angiography only 405/440 (92.0%)
Total length of calcium (including segmented) (mm)
N 405
Mean ± SE 28.6 ± 0.8
Min – Max 9.0 - 100.0
Subjects with calcium visible on both sides of the
vessel
405/405 (100.0%)
Subjects with calcification determined by IVUS 35/440 (8.0%)
Maximum degree of calcium via IVUS (°)
N 35
Mean ± SE 295.0 ± 6.1
Min - Max 270.0 - 360.0
Post-OAD balloon angioplasty was utilized in 41.1% (181/440) of the cases in the ORBIT
II clinical study based on Investigator’s preference. Per the ORBIT II protocol, all subjects
required at least one stent to be placed after treatment with OAD.
The safety of the OAS was measured by a primary safety endpoint consisting of a
composite of freedom from MACE (defined as cardiac death, MI, and TVR) at 30 days
post index procedure. Among the 443 enrolled subjects, 46 subjects experienced 30-day
post-procedural MACE events, 5 subjects were censored for 30-day post-procedural
MACE event data, and 392 subjects were free from 30-day post-procedural MACE events
for a final event free rate of 89.6%. Table 4 summarizes the Primary Safety Endpoint.