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True™ Valvuloplasty catheters True™ Flow Valvuloplasty Perfusion Catheter

True™ Flow Valvuloplasty Perfusion Catheter

26 mm x 3.5 cm balloon with a 110 cm catheter

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850 W Rio Salado Pkwy, Tempe, AZ 85281 United States
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Overview

Features:

  • First and only Valvuloplasty Perfusion Catheter*
  • Uses a unique eight chamber inflation design to allow continuous cardiac blood flow through the open central lumen
  • Designed to provide low hemodynamic resistance on the balloon while inflated
  • BD's proprietary fiber-based shell is designed to be rupture resistant
  • Available in diameters from 18 mm to 26 mm
  • In the TRUE-FLOW study1, the True™ Flow Valvuloplasty Perfusion Catheter achieved successful pre-dilatation
    of a stenotic aortic valve and remained stationary with clinically-acceptable intraventricular pressures in 91.3% of patients without rapid pacing.**

 

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References

*In EU and US markets, as of April 2021

** Any decision regarding the conduct of any specific procedure, including rapid pacing, must be made by the physician, who should follow appropriate institutional guidelines and consider all circumstances relevant to the clinical situation.

The True™ Flow Valvuloplasty Perfusion Catheter is indicated for balloon aortic valvuloplasty. Risks associated with this device are similar to all devices used for balloon valvuloplasty procedures. Not for use in patients with annular dimensions <18mm.

Illustration by Mike Austin. Copyright © 2021. All Rights Reserved.

1 True™-Flow feasibility study: 24 patients were treated with the True™ Flow Valvuloplasty Perfusion Catheter to dilate stenotic aortic valves prior to TAVR. Successful dilatation of the aortic valve, defined as complete opening of the valvuloplasty perfusion catheter by visual estimate and the ability of the inflated device to remain stationary with clinically-acceptable intraventricular pressures with or without ventricular pacing, was achieved in 91.3% of cases. The True™ Flow Valvuloplasty Perfusion Catheter moved on average 2.0 ± 4.5 mm while fully inflated. Pressure values remained stable during the procedures, with no evidence suggestive of volume overload of the left ventricle during device inflation. All cases were performed without rapid ventricular pacing (i.e., ≤ 180 bpm); however, two patients had pre-existing pacemakers that were set to mild or reduced ventricular pacing (mean: 140.0 ± 28.28 bpm) during the procedure.

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information.

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Specification

GTIN - each

00801741097683

1


Balloon Diameter

26 mm

Balloon Length

3.5 cm

3

6

Sheath Size

16 F

Shaft Length

110 cm

GTIN

GTIN - each 00801741097683 1

Product Basic Specification

Balloon Diameter 26 mm
Balloon Length 3.5 cm
3
6
Sheath Size 16 F
Shaft Length 110 cm
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