Sterilization; Disclaimer Of Warranties; Patents - Biostable HAART 200 Instrucciones De Uso

Leaflet Reconstruction
When indicated, leaflet reconstruction should be performed after annu-
loplasty Device insertion and according to established aortic leaflet recon-
struction techniques. Annuloplasty device insertion moves the annulus and
leaflets toward the center of the valve, but significant leaflet prolapse may
still be present. Leaflet prolapse may be corrected by plication sutures in the
leaflet free-edge, or by closing the cleft of a Type 1 valve. If present, struc-
tural leaflet defects may be corrected, using pericardial reconstruction or
other methods, consistent with the surgeon's training and preferences. The
goal is to achieve equal lengths of both leaflets and equal effective heights
of > 8 mm.
Settepani F, Cappai A, Raffa G, et al. Cusp repair during aortic
valve-sparing operation: technical aspects and impact on results. J
Cardiovasc Med (Hagerstown). 2015 Apr;16(4):310-7.
Mazzitelli D, Stamm C, Rankin JS, et al. Leaflet reconstructive
techniques for aortic valve repair. Ann Thorac Surg. 2014
Dec;98(6):2053-60.
Assessment of Valve Repair
After completing the Device implantation and leaflet reconstruction,
the leaflets should be inspected and the aorta at the commissures
should be stretched laterally to assess relative leaflet lengths and
heights. Both leaflets should be equal in length and vertical with good
effective height and surface of coaptation. The leaflets should meet in
the midline with no evidence of central gaps or leaflet prolapse. Finally,
leaflets should be opened widely to ensure a good orifice.
Effective height and geometric height may be assessed using the
Gage Sphere provided in the HAART 201 Instrument Set (Figure 11).
The Gage Sphere has two different vertical scales marked on the sur-
face. One scale originates at the apex of the Sphere and is intended for
estimating the vertical effective height of the valve leaflet from the leaf-
let base to the free-edge margin (Figure 12). For a successful repair,
leaflet effective height should be approximately 8 to 10 mm. Thus, as
the Gage Sphere is gently pressed down into the leaflet-sinus com-
plex, a successful repair will be associated with the leaflet free-edge
being at the level of the Gage Sphere equator. The second scale may
be used to assess leaflet geometric lengths, when desired, for further
evaluation of leaflet size and symmetry after the overall valve repair.
Figure 11. Diagram of leaflet geometric height and effective height
DWG-01-023 Rev. B - ©2021
Geometric
Effective Height
Height
Figure 12. Geometric Height Scale (left) and
Effective Height Scale (right)

11.4. Sterilization

The HAART 200 Aortic Annuloplasty Device is provided sterile on the
Holder and must not be resterilized. Devices that have been damaged
or contaminated should not be used. Pledgets are provided sterile and
must not be resterilized. Pledgets that have been damaged or contami-
nated from patient contact should not be used.

Disclaimer of Warranties

Although the HAART 200 Aortic Annuloplasty Device and HAART 201
Instrument Set, hereafter referred to as "product," have been manufac-
tured under carefully controlled conditions, BioStable Science & Engi-
neering has no control over the conditions under which this product is
used. BioStable Science & Engineering and its affiliates (collectively,
"BioStable"), therefore, disclaims all warranties, both express and
implied, with respect to the product, including, but not limited to, any
implied warranty of merchantability or fitness for a particular purpose.
BioStable shall not be liable to any person or entity for any medical
expenses or any direct, incidental, or consequential damages caused
by any use, defect, failure, or malfunction of the product, whether a claim
for such damages is based upon warranty, contract, tort, or otherwise.
No person has any authority to bind BioStable to any representation or
warranty with respect to the product.
The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty and
Limitation of Liability is held by any court of competent jurisdiction to be
illegal, unenforceable, or in conflict with applicable law, the validity of the
remaining portion of the Disclaimer of Warranty and Limitation of Liabil-
ity shall not be affected, and all rights and obligations shall be construed
and enforced as if this Disclaimer of Warranty and Limitation of Liability
did not contain the particular part or term held to be invalid.

Patents

Patents: US8,163,011; US8,425,594; US9,161,835; US9,814,574;
US9,844,434; US10,130,462; US10,327,891; CA 2,665,626; JP5881653;
JP5877205; JP6006218; EP2621407; EP2621408; other applications
pending.
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