Accessories; Size Designations; Contraindications; Warnings - Biostable HAART 300 Instrucciones De Uso

4.3. Accessories

The HAART 301 Instrument Set (Figure 3) is comprised of two (2) Han-
dles, four (4) Sizers and a Gage Sphere. Handles are made from ASTM
A276 stainless steel and the Sizers and Gage Sphere are fabricated
from polyphenylsulfone.
The Handle may be threaded into the Sizers and Gage Sphere. The
Handle may also be threaded into the face of the Holder to facilitate
removal of the Device from the packaging and positioning the Device
during the procedure (Figure 2). The Handle may be bent in the nar-
rowed section to present the Sizers, Gage Sphere, and Device to the
surgical site in the desired manner.
Warning: The Sizers, Gage Sphere, and Handle are intended for multi-
ple uses provided they are inspected before each use for signs of dam-
age. A cleaning and steam sterilization process has been validated for
these reusable instruments for use by the hospital. Before each use,
the Sizers and Gage Sphere should be visually inspected for crazing of
polymer materials, cracks, signs of structural weakness, or unreadable
markings. The Handle should be inspected for visible cracks or signs of
structural weakness before each use and after bending. Replace any
instrument that exhibits these faults as they may not function properly
and could cause patient injury. For more information on instruments, see
the HAART 301 Instrument Set IFU.
Figure 1. HAART 300 Aortic Annuloplasty Device on holder
Figure 2. HAART 300 Aortic Annuloplasty
Device and holder affixed to handle
Figure 3. HAART 301 Instrument Set
DWG-01-009 Rev. N - ©2021

4.4. Size Designations

In patients with chronic aortic valve insufficiency or aortic root aneu-
rysms, the three-dimensional anatomy of the aortic valve is typically
distorted due to dilation of the aortic valve annulus. Consequently, direct
measurements of annular diameter cannot be used to determine the
size of the HAART 300 Aortic Annuloplasty Device needed to produce
leaflet coaptation. The HAART 300 Aortic Annuloplasty Device was
developed from mathematical analyses of normal human computed
tomography (CT) angiograms and exhibits 2:3 elliptical base geometry
and 3 equidistant 10° outwardly flaring subcommissural posts. Based
upon CT angiographic analysis and empirical observations the leaflet
free-edge length is approximately one half of the circumference of the
elliptical valve annulus in normal aortic valves. The size designations
for the HAART 300 Aortic Annuloplasty Device and the procedure used
to determine the appropriate Device size are based upon the following
mathematical relationships.
L = ½ C and D = 2L/π ≈ L/1.5
L = the leaflet free-edge length
C = the circumference of the elliptical valve annulus
D = diameter of the spherical Sizer
(corresponds to the size designation of the Device)
The leaflet free-edge length is determined using the spherical Sizers.
A Sizer is chosen so that the leaflet free-edge length approximately
matches 180° of the circumference of the Sphere at the equator.
The diameter of that Sizer is recommended as the size of the Device
required. The HAART 300 Aortic Annuloplasty Device chosen through
this method will have an elliptical circumference at its base that is equal
to twice the leaflet free-edge length.
Detailed procedures for determining the appropriate HAART 300 Aortic
Annuloplasty Device size are provided in the Directions for Use Section.

5. Contraindications

• The Device is contraindicated in patients with a porcelain aorta.
• The Device is contraindicated in patients with evolving bacterial
endocarditis.
• The Device is contraindicated in patients with heavily calcified valves.

6. Warnings

• The HAART 300 Aortic Annuloplasty Device is for Single Use Only.
Do not re-use the Device. In addition to the risks listed under Possible
Complications, re-use may cause procedural complications including
Device damage, compromised Device biocompatibility, and Device
contamination. Re-use may result in infection, serious injury, or
patient death.
• The decision to use an annuloplasty device must be made by the
responsible physician on an individual basis after evaluation of the
risks and benefits accrued to the patient in comparison to alternate
treatment.
• Do not attempt to deform or reshape the annuloplasty Device.
• The HAART 300 Aortic Annuloplasty Device has been sterilized
by gamma irradiation methods and is provided sterile in a double
packaged container. No steam sterilization cycle has been validated
for the sterilization of the Device.
• Valve repair patients subjected to subsequent dental procedures or
other surgical procedures should receive prophylactic antibiotic drug
therapy to minimize the risk of systemic bacteremia and prosthetic
endocarditis.
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