EFS of Pivot-TR temporary was finalized
December 2022
Tau Medical Inc.
Tau Medical announced its finalization of early feasibility study of its temporary TR (Tricuspid valve Regurgitation) mitigating technology, the Pivot-TR temporary.
The procedure was performed by experienced teams in two medical centers in Korea.
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.
Total seven patients with torrential and severe TR were enrolled for the study and showed the result of mitigated TR when the Pivot-TR is delivered
with simple procedure.
The official result will be released in a conference on May.
[Pivot-TR]
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.
이전글 | 제3자 배정 신주발행 (수정) 공고 | 2024-05-27 |
다음글 | Pivot-TR bridge received approval for EFS to treat TR | 2023-01-09 |