HawkOne directional atherectomy system
The DIRECT Trial results
The randomized DIRECT Trial1 demonstrated that lesions treated with the HawkOne™ directional atherectomy system had greater plaque volume reduction and luminal gain — with similar safety profiles — than those treated with the CSI Diamondback 360®* peripheral orbital atherectomy system. Results confirmed through IVUS and angiography.
Percent stenosis by angiography
There was a greater reduction in stenosis following directional atherectomy (DA) compared to orbital atherectomy (OA).
Pretreatment
DA: 90.7% | OA: 87.3%
(p = 0.48)
Post-atherectomy
DA: 39.5% | OA: 69.8%
(p < 0.001)
Post-DCB
DA: 16.7% | OA: 33.7%
(p < 0.001)
Representative case examples
Directional atherectomy — IVUS area stenosis
Pretreatment
69.2%
Post-atherectomy
54.1%
Post-DCB
5.6%
Orbital atherectomy — IVUS area stenosis
Pretreatment
84.2%
Post-atherectomy
74.8%
Post-DCB
59.8%
Plaque volume
Greater plaque volume reduction was achieved with directional atherectomy group compared to orbital atherectomy group. This difference in plaque volume reduction persisted following drug-coated balloon (DCB) utilization.
Plaque volume (worst 10 mm segment)†
Pretreatment
DA: 81.8% | OA: 82.2%
(p = 0.8)
Post-atherectomy
DA: 66.5% | OA: 75.6%
(p = 0.0002)
Post-DCB
DA: 54.5% | OA: 61.3%
(p = 0.003)
Plaque volume (entire lesion)†
Pretreatment
DA: 68.3% | OA: 69.0%
(p = 0.43)
Post-atherectomy
DA: 61.4% | OA: 67.0%
(p = 0.06)
Post-DCB
DA: 53.2% | OA: 56.7%
(p = 0.01)
Stent placement rate
- HawkOne directional atherectomy (DA):
- Diamondback 360 orbital atherectomy (OA):
(p = 0.02)
Safety events and complications
Overall directional and orbital atherectomy were found to be safe with minimal complications.
- Perforations:
- Distal embolic protection device used:
- Distal embolization post-DCB:
- Perforations:
- Distal embolic protection device used:
- Distal embolization post-DCB:
Results may not be indicative of clinical performance, and are dependent on experience and training. The DIRECT study was an investigator-initiated study supported by an institutional grant from Medtronic. Three-year follow-up is ongoing to determine whether these acute performance measures are associated with improved clinical outcomes.
Risks may include but are not limited to: arterial perforation, embolism or arterial thrombosis, arterial dissection, arterial spasm, and vascular complications that could require surgical repair.
HawkOne directional atherectomy system
From simple to complex cases, the HawkOne directional atherectomy system offers the versatility and efficiency physicians need to remove plaque and restore flow.
Download
Related clinical information
Related pages
*
™Third-party brands are trademarks of their respective owners.
†
Values are expressed as median (interquartile range).
Reference
1
Babaev A, Halista M, Bakirova Z, et al. Directional versus orbital atherectomy of femoropopliteal artery lesions: Angiographic and intravascular ultrasound outcomes. Catheter Cardiovasc Interv. October 2022;100(4);687–695.