Stellarex ATK 0.035" Exceptional Balloon Performance

Efficiency as easy as 1-2-3

1. Limit wire exchanges.

Low tip profile hugs guide wire. Limit change-outs to 0.035.

2. Fast tracking.

Strong tip limits tip flaring for easy lesion crossing and trackability.

3. Less waiting.

Low 60-sec inflation hold time.

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Low tip profile (0.039")

Low tip profile and high pushability facilitate trackability and lesion crossing, even in challenging anatomies and previously deployed stents

Highest rated
burst pressures

Designed to provide nominal and burst pressures appropriate for all lesions—common to complex

Long catheter working lengths (80 and 135cm)

Lengths accommodate distal lesion locations, preferred treatment algorithm, alternative access sites and taller patients

Easy-to-remove
protective
sheath

Facilitates low particulate loss during sheath removal

Durable coating

Low particulate loss during handling and prep

Low drug dose
of 2µg/mm²

Limits paclitaxel exposure, especially when treating with multiple balloons

DISCLAIMER: This website is intended for physician education only. Patients should consult with their physician with questions related to PAD.

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IMPORTANT SAFETY INFORMATION

The Stellarex 0.035" OTW drug-coated angioplasty balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation of de novo or restenotic lesions up to 180mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.

The Stellarex 0.035" OTW drug-coated angioplasty balloon is contraindicated for use in:

Patients with known hypersensitivity to paclitaxel or structurally related compounds
Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy
Women who are breastfeeding, pregnant or are intending to become pregnant, or men intending to father children
Coronary arteries, renal arteries and supra-aortic/cerebrovascular arteries
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system

Possible adverse effects associated with the balloon dilation procedure include, but are not limited to: Abrupt vessel closure; Allergic reaction to contrast medium, antiplatelet therapy or catheter system components (drug, excipients and materials); Amputation/Loss of limb; Arrhythmias; Arterial aneurysm; Thrombosis; Arterio-venous fistula (AVF); Bleeding; Death; Embolism/Device embolism; Fever; Hematoma; Hemorrhage; Hypertension/Hypotension; Infection or pain at insertion site; Inflammation; Ischemia or infarction of tissue/organ; Occlusion; Pain or tenderness; Peripheral edema; Pseudoaneurysm; Renal insufficiency or failure; Restenosis; Sepsis or systemic infection; Shock; Stroke/Cerebrovascular accident; Vessel dissection, perforation, rupture, spasm or recoil; Vessel trauma that requires surgical repair; Balloon rupture; Detachment of a component of the balloon and/or catheter system; Failure of the balloon to perform as intended; Failure to cross the lesion.

Additional complications that may be associated with the addition of paclitaxel to the balloon include, but may not be limited to the following: Allergic/Immunologic reaction to paclitaxel; Alopecia; Anemia; Gastrointestinal symptoms (diarrhea, nausea, pain, vomiting); Hematologic dyscrasia (including neutropenia, leukopenia, thrombocytopenia); Hepatic enzyme changes; Histologic changes in vessel wall including inflammation, cellular damage or necrosis; Myalgia/Arthralgia; Myelosuppression; Peripheral neuropathy.

Caution: Federal law restricts this device to sale by or on the order of a physician

Stellarex balloon performance