How Supplied; Packaging; Storage; Directions For Use - Biostable HAART 300 Instrucciones De Uso

10. How Supplied

10.1. Packaging

The HAART 300 Aortic Annuloplasty Device is available in 19, 21, 23 and
25 mm sizes. Each HAART 300 Aortic Annuloplasty Device shelf box
contains Pledgets and a single annuloplasty Device assembly consist-
ing of the Device sutured onto its corresponding Holder. The assembled
Device and Holder are packaged within nested, sealed trays. Pledgets
are packaged separately within nested pouches. The packaging system
is designed to ease placement of the Devices into the sterile field. The
components within the packaging are sterile if the pouches, trays, and
lids are undamaged and unopened. The surfaces of the outer packaging
are NONSTERILE and must not be placed in the sterile field.

10.2. Storage

Store the product in its original packaging, including the outer shelf
Store the product in its original packaging, including the outer shelf box,
in a clean and dry area to protect the product and minimize the potential
for contamination. Stock rotation is recommended at regular intervals to
ensure usage before the expiration date printed on the box label. Do not
use the Device after the expiration date printed on the label.

11. Directions for Use

11.1. Sizing

The HAART 300 Aortic Annuloplasty Device size should be selected
based on the free-edge lengths of the valve leaflets. The free-edge
length is determined using the Sizers provided in the HAART 301 Instru-
ment Set. Sizers are provided in 19, 21, 23, and 25 mm diameters to
correspond to the four HAART 300 Aortic Annuloplasty Device sizes.
The listed Device size refers to the diameter of a circle with equivalent
circumference to the elliptical ring.
Correct annuloplasty device sizing is an important element of successful
valve repair. The appropriate HAART 300 Aortic Annuloplasty Device
size is selected by threading each individual Sizer onto the Handle and
inserting it behind the valve leaflet such that the leaflet free-edge length
between commissural insertions lies smoothly along the circumference
of the Sizer. The appropriate Sizer for a given leaflet has been selected
when the distance from one stippled area to the other matches the leaf-
let free-edge length from one commissure to the other (Figure 4). If the
leaflet free-edge length is between two sizes, choose the smaller of the
two size options. The size number on the corresponding Sizer indicates
the appropriate Device size based on the leaflet measured.
Figure 4. Proper sizing of leaflet free-edge length using the sizer
DWG-01-009 Rev. N - ©2021
All 3 leaflet free-edge lengths should be checked with the Sizers before
selecting the final HAART 300 Aortic Annuloplasty Device size. If leaflet
sizes differ by one size, the smaller Device size should be selected. If
leaflet sizes differ by more than one size, an intermediate size is consid-
ered, or more advanced techniques, such as leaflet replacement, may
be appropriate.

11.2. Handling and Preparation Instructions

Each Device is supplied mounted on a Holder and is packaged in nested,
sealed trays to ease transfer of the Device into the sterile field. Pledgets
are packaged within nested pouches. The inner pouches and sealed
trays should be inspected for damage prior to opening. Do not use the
Device if the sterile packaging has been compromised.
The Holder should be attached to the Handle contained within the
HAART 301 Instrument Set to facilitate removal of the Device from the
packaging and placement of the Device within the aortic root. For ease of
orientation, the face of the Holder is marked in 3 segments (Figure 5). The
segment marked R should face the Right coronary cusp. The segment
marked L should face the Left coronary cusp and the N segment should
face the Noncoronary cusp. The post between the N and L segments
should be placed into the aorta adjacent to the mitral valve.

11.3. Device Implantation

Post Sutures
Insertion is begun by suturing all three posts of the Device to the three
subcommissural areas using "Cabrol-like" configurations with gener-
ous bites taken in the aortic wall, using 4-0 polypropylene horizontal
mattress sutures supported by Pledgets above the annulus (Figure 6).
Polypropylene suture is recommended for suturing the posts to facil-
itate easy tightening of the sutures and passage of the Device below
the valve.
Figure 6. Suturing technique for the
HAART 300 Aortic Annuloplasty Device Posts
Figure 5. HAART 300
Aortic Annuloplasty
Device on holder
5