First human use of Pivot-TR temporary
Tau Medical Inc.
Tau Medical announced the first human use of its temporary TR (Tricuspid valve Regurgitation) mitigating technology, the Pivot-TR temporary. The procedure was performed by an experienced team in PNUYH (Pusan National University Yangsan Hospital).
The patient had severe tricuspid regurgitation (TR) with reduced heart function and planned to get an open surgical repair.
The Pivot-TR temporary is a banana-shaped, balloon-type spacer without any traumatic anchor, which allows for temporary implantation of the device to mitigate the TR. So, it can be used for checking the heart’s durability to the mitigated TR, the condition after open surgical repair.
The delivery was done with simple procedure, and the device was retrieved after checking the reduction of TR and whether the spacer was working.
The Pivot-TR temporary was approved for Early Feasibility Study by the Korean Ministry of Food and Drug Safety (MFDS).
The Pivot-TR is a three-dimensional spacer that blocks the blood regurgitation by passing through the valve coaxially, which can be delivered by minimally invasive catheters in a simple procedure. Due to simple and atraumatic anchors such as a long nose and a spiral tail, it can be delivered easily within several minutes and retrieved if necessary.
The Pivot-TR can be categorized into three versions: the Pivot-TR temporary is for checking the heart’s durability to the mitigated TR before open surgical repair.
The Pivot-TR bridge can be implanted for less than four weeks to mitigate the severe TR to mild TR, allowing patients to be safe enough to get open surgical repair.
The Pivot-TR permanent is a permanently implantable version to treat the TR without open surgical repair. The Pivot-TR temporary is under EFS in KR, the Pivot-TR bridge is just about to start the EFS in KR, and the Pivot-TR permanent is preparing for IDE (Investigational Device Exemption) submission to the U.S. FDA.
[Tau Medical Inc.]
Tau Medical is developing trans-catheter devices for structural heart diseases like MR (Mitral valve regurgitation) and TR (Tricuspid valve regurgitation).
Tau’s Cerclage MR is well known as an innovative annuloplasty treatment for MR and enlarged LV reshaping, and is now under clinical study.
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