Driver Coronary Stent System Coronary Artery Disease (CAD)

Driver® coronary stent

Overview

The Driver® coronary stent is designed to treat coronary artery disease. It increases blood flow by opening up your artery and keeping it open. The stent acts as a scaffolding to provide permanent support to the artery wall after angioplasty.

Key Features

Advanced Design
Ultrathin, round struts offer smoother delivery and less stress on tissue.

Durable Construction
Made from an advanced cobalt alloy.


Placement

The stent is implanted in the diseased section of your coronary artery in a procedure called balloon angioplasty.


Size

The device is not shown actual size. Other sizes may be available.

Diameter 0.12" (3 mm)
Length 0.71" (18 mm)

Important Safety Information

Driver® Coronary Stent System

Intended Use

  • The Medtronic Driver MX2/Over-the-Wire Coronary Stent Delivery Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3.0 mm to 4.0 mm and ≤30 mm in length using direct stenting or predilatation.


Contraindications

  • Patients in whom antiplatelet and/or anticoagulation therapy iscontraindicated.
  • Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.


Warnings/Precautions

  • Judicious selection of patients is necessary since the use of this device carries the associated risk of subacute thrombosis, vascular complications and/or bleeding events. Administration of appropriate anticoagulant, antiplatelet and coronary vasodilator therapy is critical to successful stent implantation and follow-up.
  • Patients allergic to F-562 cobalt-chromium alloy may suffer an allergic reaction to this implant.
  • Only physicians who have received appropriate training should perform implantation of the stent.
  • Stent placement should only be performed at hospitals where emergency coronary artery bypass graft surgery can be readily performed.
  • Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of endothelialized coronary stents is unknown at present.
  • When multiple stents are required, stent materials should be of similar composition. Placing multiple stents of different materials in contact with each other may increase the potential for corrosion. Data obtained from in vitro corrosion tests using a F562 CoCr alloy stent (Medtronic Driver Coronary Stent) in combination with a 316L stainless steel alloy stent (Medtronic S7 Coronary Stent) do not suggest an increased risk of in vivo corrosion.
  • If the physician encounters difficulty while trying to cross the lesion by direct stenting and determines the lesion to be uncrossable, this patient should be treated per predilatation practice. The stent (the same stent if undamaged) or a new stent of the same kind should then be advanced and deployed with predilatation.
  • Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilatation, placement of additional stents or other).
  • Outcomes (beyond 270 days) for this permanent implant are unknown at present.


Adverse Events

  • Potential adverse events that may be associated with the use of a coronary stent in native coronary arteries (including those listed in the Driver Instructions for Use) are death, myocardial infarction, emergency coronary artery bypass graft surgery (CABG), stent thrombosis, bleeding complications, stroke/cerebrovascular accidents, vascular complications, stent failures, acute myocardial infarction, myocardial ischemia, arrhythmias (including ventricular fibrillation and ventricular tachycardia dissection), distal emboli (air, tissue or thrombotic emboli), hemorrhage requiring transfusion, perforation, restenosis of stented segments, stent embolization, total occlusion of coronary artery, cardiac tamponade, femoral pseudoaneurysm, spasm, hypotension/ hypertension, allergic reaction to drugs/contrast medium/stent material, peripheral ischemia, peripheral nerve injury, infection and pain at the insertion site, and hematoma.


Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

For further information, please call Medtronic at 1-888-283-7868.

The device that appears in this graphic is a representation of a Medtronic device.


Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.