Clinical data for the HawkOne™ directional atherectomy system and IN.PACT™ Admiral™ drug-coated balloon (DCB)
The REALITY Study, sponsored by the VIVA physicians, demonstrates how the use of the HawkOne™ directional atherectomy system, followed by the IN.PACT™ Admiral™ drug-coated balloon (DCB), can help achieve positive patient outcomes in treating peripheral artery disease (PAD).
86.2% bilateral calcium [PACSS 3+4]
67.6% bilateral calcium ≥ 5 cm [PACSS 4]
17.9 cm average lesion length
39.0% chronic total occlusions at baseline
Data reported includes patients beyond the follow-up window.
Data reported includes patients beyond the follow-up window.
The REALITY Study was independently sponsored and conducted by the VIVA physicians. The study prospectively enrolled 102 participants whose treatment outcomes were independently adjudicated by angiographic and duplex ultrasound core labs and a clinical events committee. The research was funded by Medtronic through the manufacturer’s external research program (ERP).
Treat above and below the knee with the HawkOne™ directional atherectomy system to remove plaque in patients with peripheral arterial disease (PAD).
The IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons (DCB) are proven treatments for femoropopliteal disease.
ꝉ The vessel image is an example of a REALITY Study lesion. It is for illustrative purposes only, and is not representative of an exact lesion from a patient in the study.
‡ Major adverse event (MAE) was defined as flow-limiting dissections (D-F), vessel perforations requiring stenting or stent grafts, unplanned amputation, intra procedural distal athero embolization, and clinically driven target vessel revascularization (TVR).
