*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.