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THE REALITY STUDY HawkOne Directional Atherectomy System + IN.PACT Admiral Drug-Coated Balloon

SFA Therapy
Alert Indications, Safety, and Warnings for HawkOne Directional Atherectomy System
Alert Indications, Safety, and Warnings for IN.PACT Admiral Drug-Coated Balloon

Overview

Impressive Alone. Better Together. Your New Reality.

The REALITY Study1 demonstrates how optimizing the combination of HawkOne™ directional atherectomy and IN.PACT™ Admiral™ drug-coated balloon (DCB) in treating peripheral artery disease (PAD) can help achieve excellent patient outcomes.

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.

Lesion Characteristics†:

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

86.2%

Bilateral calcium [PACSS 3+4]

17.9 cm

Average lesion length

67.6%

Bilateral calcium ≥ 5 cm [PACSS 4]

39.0%

Chronic total occlusions at baseline 

OUTCOMES IN COMPLEX, LONG, HEAVILY CALCIFIED LESIONS.1

Circle chart showing 8.8% bailout stent rate REALITY Study 12-month outcomes in orange

BAILOUT STENT RATE

Circle chart showing 14.0% major adverse events REALITY Study 12-month outcomes in orange

30-DAY MAJOR
ADVERSE EVENTS‡

Circle chart showing 76.7% patency REALITY Study 12-month outcomes in orange.

12-MONTH PATENCY
Data reported includes patients beyond the follow-up window.

Circle chart showing 92.6% freedom from CD-TLR REALITY Study 12-month outcomes in orange

12-MONTH FREEDOM
FROM CD-TLR
Data reported includes patients beyond the follow-up window.

Resources

Market-leading Products

HawkOne directional atherectomy and IN.PACT Admiral drug-coated balloon on blue background

Comprehensive Peripheral Portfolio

View Peripheral Catalog

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.

Learn about HawkOne Device

IN.PACT Admiral DCB

The only DCB proven through 5 years with 75% of patients reintervention-free.2 Now backed by 5-year global study data.3

Learn about IN.PACT Admiral DCB

Access & Crossing Tools

Directional Atherectomy & Embolic Protection

Balloons

Stents

Physician Perspectives

Read articles from physician experts on PAD therapy.

View Articles
Female physician in white lab coat

Connect with Us

CardioVascular Lifeline 
Customer Support
1-763-526-7890
rs.cstechsupport@medtronic.com

Orders
1-763-514-8510
rs.cuvasorders@medtronic.com

24-hour Technical Support
+1-763-514-4000 (worldwide)

*

™Third party brands are trademarks of their respective owners.

†

This 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 TVR.

References

1

Rocha-Singh, K. Data presented at VIVA 2020.

2

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

3

Zeller T. Data presented at VIVA 2020.