Impressive results.
Your new REALITY. 

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).

HawkOne directional atherectomy system on transparent background

HawkOne directional
atherectomy system

IN.PACT Admiral drug-coated balloon on transparent background

IN.PACT Admiral
drug-coated balloon

Lesion characteristics*1:

  • 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


Illustration of a 10 cm long vessel with 5 cm long bilateral calcium with lesion shown in yellow and calcium in white

Outcomes in complex, long, heavily calcified lesions1:

8.8% bailout stent rate

14.0% 30-day major adverse events

76.7% 12-month patency
Data reported includes patients beyond the follow-up window. 

92.6% 12-month freedom from clinically driven target lesion revascularization (CD-TLR)
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).

Market-leading products 

Comprehensive peripheral portfolio

Choose from a full portfolio of peripheral products for endovascular interventions — products that help you reach your PAD patient treatment goals.

HawkOne directional atherectomy system

From simple to complex cases, the HawkOne directional atherectomy system offers the versatility physicians need to remove plaque and restore flow.


Maintain long-term vessel patency with IN.PACT Admiral DCB, backed by five years of efficacy data,2 even in complex lesions.3

Physician perspectives

Read articles from physician experts on PAD therapy.

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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).



Rocha-Singh KJ, Sachar R, DeRubertis BG, et al. Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study. Catheter Cardiovac Interv. 2021;98(3):549-558.


Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.


Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA 2021. CTO information was collected and evaluated in real-world studies. Please see brief statement for approved indications for use.