Tendyne Apical Pad - Mitral transcatheter heart valve bioprosthesis

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Mevcut itibaren:

Abbott Medical Australia Pty Ltd

Sınıf:

Class III

Tarafından üretildi:

Abbott Medical 177 County Road B East, St Paul, Minnesota, 55117 United States Of America

Terapötik alanı:

60246 - Mitral transcatheter heart valve bioprosthesis

Terapötik endikasyonlar:

The Tendyne Apical Pad is available in a large and a small size. It is comprised of a PEEK (polyether ether ketone) button covered by a double velour polyster (PET) fabric. The nitinol leader and tether are threaded through the Apical Pad to affix the pad to the epicardial surface of the heart near the apex. The cam portion of the PEEK button is moveable to lock and unlock the Apical Pad to the tether. The Tendyne Apical Pad is intended to secure the valve after Tendyne Mitral Valve delivery and system withdrawal.

Yetkilendirme durumu:

A

Yetkilendirme tarihi:

2022-12-14