The Stellarex below-the-knee 0.014" drug-coated angioplasty balloon is built on the same platform as our 0.035″ above-the-knee DCB, which has demonstrated consistently high patency rates and safety in a wide range of patients across multiple clinical trials.
0.014" DCB is not approved for distribution, sale or use in the USA.
Availability of this product may vary by country.
Stellarex is the only commercially available DCB for the SFA with two reported randomized controlled trials, four other clinical trials (N = 1,079)6 and the largest number of randomized patients (N = 628).6 Across clinical trials, Stellarex delivers consistent results.
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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:
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.
©2018 Koninklijke Philips N.V. All rights reserved. Some or all products manufactured by Spectranetics, a Philips company. Approved for external distribution. D037951-07 092018