Boston Scientific Promus Element Plus Stent

PROMUS Element™ Plus

Everolimus-Eluting Platinum Chromium Stent System
Indications, Safety, and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE

The PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length.

CONTRAINDICATIONS

Use of the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is contraindicated in patients with known hypersensitivity to: 316L stainless steel or platinum ∙ everolimus or structurally-related compounds ∙ polymers or their individual components, Primer Polymer and Drug Matrix Copolymer Carrier). Coronary Artery Stenting is contraindicated for use in: Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy (see Section 6.2, Pre- and Post-Procedure Antiplatelet Regimen for more information). ∙ Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.