REALITY Study

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

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Please refer to your region’s instructions for use (IFU) for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 877-526-7890. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.Reference statementImportant informationIndications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.Indications for useThe HawkOne™ peripheral directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne™ catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions. The HawkOne™ catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.Potential Adverse Effects of the Device on HealthThe potential complications include, but are not limited to, amputation, aneurysm, arterial dissection, arterial perforation, arterial rupture, arterial spasm, arteriovenous fistula, bleeding complications, death, embolism or arterial thrombosis, emergency or non-emergency arterial bypass surgery, entry site complications, hypotension, infection, ischemia, restenosis of the treated segment, total occlusion of the peripheral artery, or vascular complications that could require surgical repair.Caution: Federal law (United States) restricts this product for sale by or on the order of a physician.FTSOP113326-55 Rev. 1B
UC201712496-01aEN

IN.PACT™ Admiral™
drug-coated balloon

Indications, Safety, and WarningsIndications for useThe IN.PACT Admiral™ paclitaxel-coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.ContraindicationsThe IN.PACT Admiral™ DCB is contraindicated for use in:

Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries

Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy

Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system

Patients with known allergies or sensitivities to paclitaxel

Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings

Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).

Do not move the guidewire during inflation of the IN.PACT Admiral™ DCB.

Do not exceed the rated burst pressure (RBP). The RBP is 14 atm (1419 kPa) for all balloons except the 200 and 250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115kPa). The RBP is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.

The safety and effectiveness of using multiple IN.PACT Admiral™ DCBs with a total drug dosage exceeding 34,854 μg of paclitaxel in a patient has not been clinically evaluated.

Precautions

Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.

Administer appropriate drug therapy to the patient according to standard protocols for PTA before insertion of the dilatation catheter.

Take precautions to prevent or reduce clotting when any catheter is used. Flush and rinse all products entering the vascular system with heparinized normal saline or a similar solution. For the IN.PACT Admiral™ DCB catheter, flush the guidewire lumen through the guidewire port with heparinized normal saline until the fluid exits the distal tip. Do not rinse or wipe the IN.PACT Admiral™ DCB catheter.

Identify allergic reactions to contrast media and antiplatelet therapy before treatment and consider alternatives for appropriate management prior to the procedure.

Handle the product with caution to avoid any damage to the balloon coating or folded balloon.

This product is not intended for the expansion or delivery of a stent.

Do not expose the product to organic solvents such as alcohol.

To reduce the potential for vessel damage, the inflated diameter of the balloon should approximately match the diameter of the vessel just distal to the lesion.

Potential adverse effectsThe potential adverse events associated with use of the device include but are not limited to: Abrupt vessel closure, access site pain, allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients), amputation/loss of limb, arrhythmias, arterial aneurysm, arterial thrombosis, arteriovenous (AV) fistula, death, dissection, embolization, fever, hematoma, hemorrhage, hypotension/hypertension, inflammation, ischemia or infarction of tissue/organ, local infection at access site, local or distal embolic events, perforation or rupture of the artery, pseudoaneurysm, renal insufficiency or failure, restenosis of the dilated artery, sepsis or systemic infection, shock, stroke, systemic embolization, vessel spasms or recoil, and vessel trauma which requires surgical repair.Potential adverse events not captured above that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction, alopecia, anemia, gastrointestinal symptoms, hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia), hepatic enzyme changes, histologic changes in vessel wall, including inflammation, cellular damage, or necrosis, myalgia/arthralgia, myelosuppression, and peripheral neuropathy. Refer to the Physician’s Desk Reference for more information on the potential adverse effects observed with paclitaxel.CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.Important information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device, at www.medtronic.com/manuals or contact a Medtronic representative.US-CV-2601096 v1.0

Lesion characteristics^ꝉ1:

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 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

Resources

Comprehensive peripheral portfolio (open in new window)

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

PRODUCT PDF 3 MB

Contact us

Connect with a Medtronic representative to receive updates and information on our products and therapies.

CardioVascular LifeLine Customer Support
763-526-7890
Email us

Orders
763-514-8510
Email us

24-hour technical support (worldwide)
763-514-4000

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).

Impressive results.
Your new REALITY.

HawkOne™ directional
atherectomy system

IN.PACT™ Admiral™
drug-coated balloon

Lesion characteristics^ꝉ1:

Outcomes in complex, long, heavily calcified lesions¹:

8.8% bailout stent rate

14.0% 30-day major adverse events^‡

76.7% 12-month patency

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

Market-leading products

Resources

Related links

Contact us

United States

Customer Care Team

REALITY study

Impressive results. Your new REALITY.

HawkOne™ directional atherectomy system

IN.PACT™ Admiral™ drug-coated balloon

Lesion characteristicsꝉ1:

Outcomes in complex, long, heavily calcified lesions1:

8.8% bailout stent rate

14.0% 30-day major adverse events‡

76.7% 12-month patency

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

Market-leading products

Resources

Related links

Contact us

United States

Customer Care Team

Impressive results.
Your new REALITY.

HawkOne™ directional
atherectomy system

IN.PACT™ Admiral™
drug-coated balloon

Lesion characteristics^ꝉ1:

Outcomes in complex, long, heavily calcified lesions¹:

14.0% 30-day major adverse events^‡