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True™ Flow Valvuloplasty Perfusion Catheter

Valvuloplasty - Aortic

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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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Reference

*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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BD-23465v2 

Products & Accessories
RELATED PRODUCTS NOT AVAILABLE
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.

true

BD-23465v2 

Resources
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.

true

BD-23465v2 

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