Tabla De Contenido; Device Labeling Symbols; Intended Use; Indications For Use - Biostable HAART 200 Instrucciones De Uso

Instructions for Use -
HAART 200 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
5. Contraindications ................................................................................ 3
6. Warnings ............................................................................................ 3
7. Precautions ......................................................................................... 3
8. Magnetic Resonance (MR) Safety ...................................................... 4
9. Potential Adverse Events ................................................................... 4
10. How Supplied .................................................................................. 4
10.1. Packaging .................................................................................. 4
10.2. Storage ...................................................................................... 4
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-01-023 Rev. B - ©2021
Do not use if package is damaged
Catalog number
MD
Do not resterilize
MR Conditional

2. Intended Use

The HAART 200 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 bicuspid aortic valve repair.

3. Indications for Use

The HAART 200 Aortic Annuloplasty Device is indicated in adult patients
undergoing bicuspid aortic valve repair for aortic insufficiency or con-
comitant to repair of an aortic aneurysm.

4. Annuloplasty Device Description

4.1. Overview

The HAART 200 Aortic Annuloplasty Device is a three dimensional
annuloplasty ring designed to correct annular dilatation and/or maintain
annular geometry of the aortic valve in adult patients undergoing bicus-
pid aortic valve repair. The Device consists of a titanium frame machined
from medical grade Titanium 6Al-4V covered with medical grade polyes-
ter fabric affixed to the frame by suture.

4.2. Technological Characteristics

The HAART 200 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 200 Aortic Annuloplasty Device has a circular base geom-
etry with two 10°, outwardly flaring, subcommissural posts positioned at
180° around the circumference of the device. The annuloplasty device
consists of a titanium frame machined from medical grade Titanium 6Al-
4V covered 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 poly-
ester fabric, ARF001, is manufactured for annuloplasty ring applications.
HAART 200 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 200 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