SETTING A NEW
GOLD STANDARD
FOR COMPLEX PCI

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Complications, and Directions for Use.

Indications for Use

coraFlex and coraForce Catheters

Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic contrast.

coraCross Catheter

The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

Contraindications

coraFlex and coraForce Catheters

The Cora Catheter is contraindicated for use in the cerebral vasculature.

coraCross Catheter

The coraCross Catheter is contraindicated for use in the cerebral vasculature.

Warnings

• Single Use only. Do not reuse/resterilize. Reusing the device could result in compromised device performance, cross-infection and other safety related hazards.

• Do not use if device is open or packaging is damaged

• Never advance, withdraw or rotate an intravascular device against resistance until the cause is determined by fluoroscopy.

• Manipulation, advancement, and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events, resulting in coating material remaining in the vasculature or device damage. This may result in adverse events requiring additional intervention.

• Avoid wiping the device with dry gauze as this may damage the device coating. Avoid excessive wiping of the coated device.

• Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.

• Avoid pre-soaking devices, as this may impact the coating performance and has not been tested.

• The safety and effectiveness of the coated device has not been established, or is unknown, in vascular regions other than those specifically indicated

• The performance of the coraCross device has not been assessed in crossing CTOs, especially in the coronary vasculature.

Precautions

• Store in a cool, dry place. Protect from direct sunlight and high temperature.

• Use only appropriately sized ancillary device, as shown in the Specifications below.

• Use the catheter prior to the “Use By” date specified on the package

• The catheter should only be used by physicians qualified to perform percutaneous, vascular interventions.

• Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system. Use of systemic heparinization and heparinized saline solution should be considered.

• Exercise care while handling the catheter during procedure to reduce the possibly of accidental damage, kinking or bending.

• Manipulation of the catheter should only occur under fluoroscopy.

Complications

Vascular catheterization and/or vascular intervention may result in complications including but not limited to:

• Vessel dissection, perforation, rupture or total occlusion

• Hematoma

• Hemorrhage

• Arrhythmia, including ventricular fibrillation

• Unstable angina

• False Aneurysm

• Hypo/hypertension

• Thrombosis/Embolism

• Infection

• Acute myocardial infarction

• Renal Dysfunction

• Blood Loss

• Additional surgical or percutaneous intervention

• Radiation Exposure

• Death

©2024 Reflow Medical, Inc. All rights reserved. Reflow Medical, coraFlex, coraForce, coraCross and The Pulse of Medical Ingenuity are registered trademarks or trademarks of Reflow Medical, Inc. Federal law (USA) restricts these devices to sale by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Complications, and Directions for Use.