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Shapeable Support Catheter That Holds Its Angle

The Reflow Spex shapes to your preferred angle for improved and predictable vascular access.

 

View a video demonstration of the Spex

This informative video provides a brief look at the remarkable capabilities of the speX Shapeable Support Catheter.

  • Compatible with the physician’s preferred guide wire and procedural technique.
  • Combine with the Reflow Wingman™ Crossing Catheter to optimize support.
  • Use the Spex 35 Support Catheter with the Reflow SpexLP™

ACCESS FROM ANGLES

  • Promotes improved and predictable access to the vasculature.
  • Designed to fill a specific need based on clinical feedback.
  • Allows the physician to straighten or reshape the angle as needed.
  • Helps the physician perform procedures more effectively.
  • Increases lubricity with a seamless, low-profile hydrophilic coating.
  • Optimizes pushability and access through lesions
“The Spex Catheter makes it very easy to cross occlusions.”
– 
Jay Mathews, MD, MS, FACC

  • Stiff tip pierces through occlusions with guidewire
  • Direct the tip into the micro channels as needed

CUSTOMIZABLE TIP MAINTAINS THE DESIRED ANGLE

Allows the physician to shape to the preferred angle and holds it throughout the procedure

COMPATIBLE WITH YOUR PREFERRED GUIDEWIRE & PROCEDURAL TECHNIQUE

Works with the Reflow Wingman™ Catheter for added support in lesion crossing

35

Model Number – Effective Length

SPN35050 (US) SPN35050-5PK* (US)
SPN35090 (US) SPN35090-5PK* (US)
SPN35135 (US) SPN35135-5PK* (US)
SPN35150 (US) SPN351 50-5PK* (US)

Effective Length (cm)

50,90,135,150

Guidewire Compatability (in)

0.035

Max Outer Diameter (in/F)

0.06/4.6

Max Pressure (psi/kpa)

300/2068

Shapeable Tip Zone (in/mm)

.75/19

Sheath Compatibility (F/mm)

5/1.7

Hydrophilic Coating (cm)

40

*(-5P) Indicates 5 pack availability

©2024 Reflow Medical, Inc. All rights reserved. Reflow Medical, Spex, Wingman, 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.

Indications, Safety, & Warnings

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

SpeX 35 Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the 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/therapeutics agents.

Contraindications

The speX 35 Support Catheter is contraindicated for use in the coronary and 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.

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.

Maximum Infusion Pressure: 360 psi (2482kpa)

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

• Infection

• Hematoma

• Unstable angina

• Embolism

• Hypo/hypertension

• Acute myocardial infarction

• Arrhythmia, including ventricular fibrillation

• Death

• If the catheter is damaged, this product may cut into a blood vessel wall. Extreme caution needs to be taken when removing a damaged device. In the case of complications resulting from the removal of the entire system, stop immediately the procedure, and perform appropriate treatment at the discretion of the physician.

©2024 Reflow Medical, Inc. All rights reserved. Reflow Medical, Spex, 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.

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