Philips stellarex

Drug-Coated
Angioplasty Balloons

Featuring EnduraCoat Technology

Select a product to learn more

ATK 0.035"
BTK 0.014"

0.014" DCB is not approved for distribution, sale or use in the USA. Availability of this product may vary by country.

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

The Clear DCB Choice

No-compromise solutions to treat Peripheral Artery Disease (PAD).
Stellarex drug-coated balloons enable physicians to use a lower therapeutic drug dose and achieve top-tier patency results. With demonstrated durability and predictability in a wide range of patients, Stellarex DCBs offer a no-compromise solution for restoring and maintaining patency in the superficial femoral and popliteal arteries in patients with peripheral arterial disease.

Select a product to learn more
ATK 0.035″
BTK 0.014″

phillps
©2020 Koninklijke Philips N.V. September 2018

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

All cited trademarks are the property of their respective owners.

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.

©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

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