Stellarex Drug-Coated 0.035" Angioplasty Balloon

Top-tier outcomes with the lowest therapeutic drug dose in all patients—common to complex

Choose efficacy

Stellarex exhibits consistent two-year patency across trials, even in the most complex PAD cases. Stellarex is the only DCB reported to have durable patency at 2 years in severely calcified lesions.

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75.2%

2 yr patency In common
patients¹⁸

72.1%

2 yr patency In complex
patients³⁵

67.8%

2 yr patency In severely
calcified lesions³⁵

The Stellarex difference

Stellarex’s unique coating composition, EnduraCoat technology, combines amorphous and small-to-large crystalline paclitaxel with polyethylene glycol (PEG) excipient. The result is efficient drug transfer, effective tissue residency, high coating durability and minimal particulate loss.

About the coating

Choose low particulate

Particulate loss is associated with an increased risk of downstream embolization. In bench tests, Stellarex demonstrated 79% less particulate loss than In.Pact.⁹

Compare particulate

See more Stellarex clinical evidence

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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 drug-coated 0.035" angioplasty balloon

The clear DCB choice

Every patient deserves Stellarex