Impressive results.
Your new REALITY.
The REALITY Study, sponsored by the VIVA physicians, demonstrates how the use of the HawkOneTM Directional Atherectomy System, followed by the IN.PACTTM AdmiralTM Drug-Coated Balloon (DCB)ǂ, can help achieve positive patient outcomes in treating peripheral artery disease (PAD).
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
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 include patients beyond the follow-up window.
92.6% 12-month freedom from clinically driven target lesion revascularization (CD-TLR)
Data reported include 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.
HawkOneTM Directional Atherectomy System
From simple to complex cases, the HawkOneTM Directional Atherectomy System offers the versatility physicians need to remove plaque and restore flow.
IN.PACTTM AdmiralTM DCBǂ
Maintain long-term vessel patency with IN.PACTTM AdmiralTM DCBǂ, backed by five years of efficacy data,2 even in complex lesions.3
Contact us
Connect with a Medtronic representative to receive updates and information on our products and therapies.
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 (worldwide)
+1-763-514-4000
*
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).
‡
The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter
References
1
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.
2
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.
3
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.