Tabla De Contenido; Device Labeling Symbols; Intended Use; Indications For Use - Biostable HAART 300 Instrucciones De Uso

Instructions for Use -
HAART 300 Aortic Annuloplasty Device
Table of Contents
1. Device Labeling Symbols ................................................................... 2
2. Intended Use ...................................................................................... 2
3. Indications for Use .............................................................................. 2
4. Annuloplasty Device Description ........................................................ 2
4.1. Overview ...................................................................................... 2
4.2. Technological Characteristics ...................................................... 2
4.3. Accessories ................................................................................. 3
4.4. Size Designations ........................................................................ 3
5. Contraindications ................................................................................ 3
6. Warnings ............................................................................................ 3
7. Precautions ......................................................................................... 4
8. Magnetic Resonance (MR) Safety ...................................................... 4
9. Potential Adverse Events ................................................................... 4
10. How Supplied .................................................................................. 5
10.1. Packaging .................................................................................. 5
10.2. Storage ...................................................................................... 5
11. Directions for Use ............................................................................. 5
11.1. Sizing ......................................................................................... 5
11.2. Handling and Preparation Instructions ...................................... 5
11.3. Device Implantation ................................................................... 5
11.4. Sterilization ................................................................................ 7
Disclaimer of Warranties ........................................................................ 7
Patents ................................................................................................... 7

1. Device Labeling Symbols

Manufacturer
Keep dry
Batch code
Authorized European Rep
Consult Instructions for Use
Use by date
Do not re-use
Sterilized using irradiation
Product complies with requirements of directive 93/42/EEC for
medical devices
DWG-01-009 Rev. N - ©2021
Do not use if package is damaged
Catalog number
MD
Do not resterilize
MR Conditional

2. Intended Use

The HAART 300 Aortic Annuloplasty Device is intended to be used to
correct annular dilatation and/or maintain annular geometry of the aortic
valve in adult patients undergoing trileaflet aortic valve repair.

3. Indications for Use

The HAART 300 Aortic Annuloplasty Device is indicated in adult patients
undergoing trileaflet aortic valve repair for aortic insufficiency or concom-
itant to repair of an aortic aneurysm.

4. Annuloplasty Device Description

4.1. Overview

The HAART 300 Aortic Annuloplasty Device (Figure 1 on page 3) is a
three dimensional annuloplasty ring designed to correct annular dilata-
tion and/or maintain annular geometry of the aortic valve in adult patients
undergoing trileaflet aortic valve repair. The Device consists of a titanium
frame machined from medical grade Titanium 6Al-4V covered with medi-
cal grade polyester fabric affixed to the frame by suture.

4.2. Technological Characteristics

The HAART 300 Aortic Annuloplasty Device is comprised of three com-
ponents: the implantable Annuloplasty Device, polyester Pledgets, and
a Device Holder that is discarded during the procedure. Each of these
components is briefly described below.
Annuloplasty Device
The HAART 300 Aortic Annuloplasty Device was developed from math-
ematical analyses of normal human computed tomography (CT) angio-
grams and exhibits 2:3 elliptical base geometry and 3 equidistant 10° out-
wardly flaring subcommissural posts. The annuloplasty Device consists
of a titanium frame machined from medical grade Titanium 6AL-4V cov-
ered with medical grade polyester fabric affixed to the frame by suture.
The Device materials and the manufacturing processes were specifically
selected for use in an implantable medical device. The polyester fabric,
ARF001, is manufactured for annuloplasty ring applications. HAART 300
Aortic Annuloplasty Devices are manufactured in 4 sizes ranging from
19mm to 25mm in 2mm increments.
The titanium frame of the Device provides the stiffness to reduce the
diameter of the dilated aortic annulus while the polyester fabric provides
material to support endothelialization and direct suturing of the sub-
commissural posts to the aortic valve annulus. The inner aspects of the
Device posts have 2 layers of polyester fabric to facilitate suturing.
Polyester Pledgets
Polyester Pledgets are 7mm by 3mm and are made from the same
ARF001 fabric used to cover the Device. The Pledgets are provided with
the annuloplasty Device for use during surgery. They are supplied sterile
in a separate package within the Device shelf box. Individual packages
of 6 sterile pledgets are also available in the HAART Polyester Pledget
6-Pack.
Holder
The HAART 300 Aortic Annuloplasty Device is supplied on a Holder that
may be attached to a Handle to facilitate positioning the Device during
the procedure (Figure 2 on page 3). The Holder is machined from poly-
phenylsulfone and is attached to the annuloplasty Device using a single
suture (Figure 1 on page 3). The Device can be removed from the Holder
by severing the suture at any location along the face of the Holder.
2