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.
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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.