Directions For Use; Supra-X™ Sizer, Model 7305Ux; Od Sizer, Model 7305Od - Medtronic MOSAIC ULTRA SUPRA-X Instrucciones De Uso

UltraSupra_EN_ch.fm 7/29/05 1:15 pm
4.375 x 7.0 inches

6 DIRECTIONS FOR USE

The model number and size of each sizer is boldly marked on the handle and corresponds
to the respective valve size.
Note: Refer to the Mosaic or Hancock II Ultra™ aortic bioprosthetic valve IFU for proper
valve implantation instructions.
6.1 Supra-X™ Sizer, model 7305UX
The size of the bioprosthesis is determined using the double-ended sizer (Figure 1). The
"valve" end of the sizer is a replica of the bioprosthesis with a slightly compressed sewing
ring. The raised posts on the "valve" end correspond to the valve commissure stent posts.
The "barrel" end of the sizer is a replica of the valve sewing ring around a cylinder with a
diameter corresponding to the bioprosthesis' inside diameter. A protrusion on the sizer's
sewing ring corresponds to the widest intercommissural distance on the bioprosthesis.
For supra-annular valve implantation, the "barrel" end is passed into the valve annulus so
that the "barrel" end base sits comfortably within the annulus (Figure 2), while the flared
sewing ring portion of the sizer rests atop the patient's valve annular rim.
Supra-annular aortic valve size selection should not be based exclusively on native valve
annulus size. Consideration should also be given to the height of the patient's coronary ostia
relative to the annulus and the potential for coronary ostia obstruction due to the
bioprosthetic valve's commissure stent posts. The "valve" end (Figure 3) should be used to
assess the potential for coronary ostia obstruction. Refer to the Mosaic or Hancock II Ultra™
aortic bioprosthetic valve IFU for proper valve implantation instructions.
Caution: It is recommended that both ends of the sizer be used to determine the
bioprosthetic valve size.

6.2 OD Sizer, model 7305OD

The size of the bioprosthesis is determined using the double-ended sizer (Figure 4). The
"valve" end of the sizer is a replica of the bioprosthesis with a slightly compressed sewing
ring. The raised posts on the "valve" end correspond to the valve commissure stent posts.
The "barrel" end of the sizer is a cylinder with a diameter corresponding to the bioprosthesis'
stent outside diameter (equivalent to labeled valve size). A protrusion on the sizer's sewing
ring corresponds to the widest intercommissural distance on the bioprosthesis.
For valve implantation, the "barrel" end is passed through the patient's valve annulus (Figure
5). The "barrel" end should be in contact with the entire ring of the patient's annular tissue,
without stretching the patient's valve annulus.
Intra-annular aortic valve size selection should not be based exclusively on native valve
annulus size. Consideration should also be given to the height of the patient's coronary ostia
relative to the annulus and the potential for coronary ostia obstruction due to the
bioprosthetic valve's commissure stent posts. The "valve" end (Figure 3) can be used to
assess the potential for coronary ostia obstruction. Refer to the Mosaic or Hancock II Ultra™
aortic bioprosthetic valve IFU for proper valve implantation instructions.
Caution: It is recommended that both ends of the sizer be used to determine the
bioprosthetic valve size.
6.3 Sterilization
Warning: Supra-X™ and OD Sizers are supplied NONSTERILE and MUST be sterilized
prior to each use. Prior to sterilization, the accessories MUST be thoroughly cleaned.
4 English Instructions for Use
A12506001
Medtronic Confidential
CS006
Rev 1.0