Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
11
8. Clinical study summary
The prospective, single arm, multi-center IDE study (ORBIT II) of the DIAMONDBACK
360 OAS was conducted to evaluate the safety and effectiveness of the OAS. Four
hundred forty three (443) patients from 49 participating centers were enrolled in this
study. The primary objectives of the study were to (1) demonstrate the safety of the OAS
in treating subjects with de novo, severely calcified coronary lesions, and (2) to
demonstrate that the OAS successfully facilitates stent deployment in severely calcified
coronary lesions.
There were a total of 443 subjects enrolled with 440 subjects having OAD inserted.
Three subjects were not treated with OAD because of not meeting angiographic criteria
(2) or the OAD could not pass through the lesion (1). A summary of patient
demographics is listed below in Table 2.
Table 2.
Patient Demographics
Baseline Characteristic Result
Age (years) 71.4 ± 0.5 (N=443)
Gender (male) 286/443 (64.6%)
Ethnicity
Caucasian 389/443 (87.8%)
Black or African American 25/443 (5.6%)
Asian 9/443 (2.0%)
Hispanic or Latino 16/443 (3.6%)
Native American 1/443 (0.2%)
Other 3/443 (0.7%)
eGFR (mL/min/1.73 m
2
) 75.8 ± 1.2 (N=441)
History of diabetes mellitus 160/443 (36.1%)
History of dyslipidemia 407/443 (91.9%)
History of hypertension 406/443 (91.6%)
History of angina 348/443 (78.6%)
Prior stroke/Transient ischemic
attack
39/443 (8.8%)
Prior MI 99/443 (22.3%)
Prior CABG 65/443 (14.7%)
Smoker (current or former) 293/443 (66.1%)
eGFR = estimated glomerular filtration rate; MI = myocardial infarction;
CABG = coronary artery bypass graft