CARDIOVASCULAR
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QuickFlex®

Left-Heart Lead

Quickflex

PRODUCT HIGHLIGHTS

  • Superb deliverability combined with exceptional stability and performance.
  • Steerable tip - distal tip angle can be controlled to maneuver through venous anatomy.
  • Flexible lead body:
    • Expanded tip-to-ring electrode spacing of 20 mm.
    • Shorter tip and ring electrodes reduce the length of rigid portions of the lead body.
  • Low profile - 5.6 F proximal lead body, 5.0 F distal lead body, 4.0 F lead tip.
  • Compatible with over-the-wire or stylet approaches.
  • Composite construction - proximal polyurethane section and cable/coil conductors are designed to offer exceptional push and torque, while the flexible distal silicone portion is designed for improved tracking in tortuous anatomy.

ORDERING INFORMATION

Contents: Left-heart lead


Reorder Number Insulation Proximal Insulation Distal S-Curve Height (mm) Minimum Introducer (F) Connector Lengths (cm)
1156T/75 Polyurethane Silicone 8 7 IS-1 bipolar 75
1156T/86 Polyurethane Silicone 8 7 IS-1 bipolar 86
1158T/75 Polyurethane Silicone 16 7 IS-1 bipolar 75
1158T/86 Polyurethane Silicone 16 7 IS-1 bipolar 86


CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications/Intended Use: The QuickFlex® Model 1156T and QuickFlex® XL Model 1158T leads are intended for permanent sensing and pacing of the left ventricle when used with a compatible St. Jude Medical® biventricular system.

Contraindications: The use of QuickFlex® leads is contraindicated in patients who are expected to be hypersensitive to a single dose of 1.0 milligram of dexamethasone sodium phosphate, are unable to undergo an emergency thoracotomy procedure, have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Potential Adverse Events: Potential adverse events associated with the use of left ventricular leads include: Allergic reaction to contrast media, body rejection phenomena, cardiac/coronary sinus dissection, cardiac/coronary sinus perforation, cardiac tamponade, coronary sinus or cardiac vein thrombosis, death, endocarditis, excessive bleeding, hematoma/seroma, induced atrial or ventricular arrhythmias, infection, lead dislodgment, local tissue reaction; formation of fibrotic tissue, loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the pacing lead, myocardial irritability, myopotential sensing, pectoral/diaphragmatic/phrenic nerve stimulation, pericardial effusion, pericardial rub, pneumothorax/hemothorax, prolonged exposure to fluoroscopic radiation, pulmonary edema, renal failure from contrast media used to visualize coronary veins, rise in threshold and exit block, thrombolytic or air embolism, valve damage. Performance of a coronary sinus venogram is unique to lead placement in the cardiac venous system, and carries risks. Potential complications reported with direct subclavian venipuncture include hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage, and rarely, death.

Rev.6-012511

Last Updated: January 02, 2019

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