Abbott Tendyne TENDV-LP-29S, Instructions For Use Manual

Page: 6 / 284

IFU, TENDYNE TM Mitral Valve System Page 6 of 284
Device Description
The Tendyne TM Mitral Valve System consists of the
Tendyne Mitral Valve with Apical Pad and a Tendyne
Mitral Valve Delivery System that facilitates placement
of the valve.
1.1. Tendyne
TM
Mitral Valve with Apical Pad
The Tendyne Mitral Valve is a bioprosthesis intended for
transapical implantation within the native mitral valve.
The valve includes two (2) parts; a porcine pericardial
bioprosthetic valve and an Apical Pad (connected by a
braided tether, Figure 1). The valve has three (3) porcine
pericardial tissue leaflets sewn onto a circular, self-
expanding frame made of nitinol. The inner frame is
sewn inside a self-expanding nitinol outer frame. The
outer frame helps orient the prosthesis inside the native
mitral valve. There is a radiopaque marker at A1 that
can be visualized under fluoroscopy to confirm
orientation of the valve. The outer-frame cuff is raised
along the anterior aspect and is referred to as the A2
region. The valve is designed for radial orientation such
that the anterior aspect of the cuff rests upon the
aortomitral continuity. This orientation aligns the cuff
with the anterior portion of the native mitral valve.
The frame is covered with a PET (polyethylene
terephthalate) fabric cuff that provides the sealing
surface within the native annulus. The self-expanding
prosthesis is connected to a braided fiber tether made
of polyethylene, intended to stabilize the valve by
passing through the left ventricular myocardium near
the apex, where it is fastened to an Apical Pad on the
epicardium.
Figure 1. Tendyne
TM
Mitral Valve with Apical Pad
The valve is fully repositionable and retrievable
intraoperatively. Repositioning allows optimization of
the valve position following deployment, and retrieval
allows use of an alternative valve size if the initial valve
does not perform adequately.
The Tendyne valve is available in several sizes, as listed
in Table 1, to accommodate differing cardiac anatomies.
Two (2) sealing heights are available: Standard Profile
designated by “SP” or Low Profile, designated by “LP”.
The SP valve has an effective orifice area (EOA) of
approximately 3.0 cm 2 . The LP valve has an EOA of
approximately 2.2 cm 2 . The LP valve is designed to
accommodate patients with smaller native annulus
dimensions and to reduce left ventricular outflow tract
(LVOT) obstruction. The valve size should be selected to
provide proper fit for paravalvular sealing, device
stability and LVOT area. Standard imaging techniques
should be used to assess the native mitral valve
dimensions and left ventricular dimensions for valve
sizing. Refer to Section 11 for Patient Selection and
Treatment.