The MITRIS RESILIA mitral valve is a stented tri-leaflet prosthetic
heart valve comprised of RESILIA bovine pericardial tissue.
The MITRIS RESILIA mitral valve is indicated for the replacement of native
or prosthetic mitral heart valves. The valve is stored under dry packaging
conditions and does not require rinsing prior to implantation.
The valve is available in sizes 25 through 33 mm.
First, prepare the diseased valve for replacement with the MITRIS RESILIA mitral valve.
Size the valve and measure the
annulus using only the mitral sizers, Models 1173B, barrel, or 1173R, replica. For more
information on sizing, please see the IFU. Once you have sized the MITRIS RESILIA valve,
verify that the TagAlert, visible through the shelf carton, indicates the valve is okay to use.
Only use the valve if the TagAlert reads OK. Open the carton after
confirming that the status is OK. Remove the foil pouch from the carton in
the non-sterile field. Examine the foil pouch for evidence of damage and broken or missing seals.
Open the foil pouch and remove the outer tray from the foil pouch.
Near the sterile field, hold the base of the outer tray. Review the labels
making sure the labels indicate the correct size. After this is confirmed, peel the lid
(outer tray Tyvek) from the outer tray. The inner tray and contents are sterile.
Transfer the inner tray to the sterile field. The contents of the inner tray
must be handled using a sterile surgical technique to prevent contamination.
In the sterile field, examine the inner tray and lid for evidence of damage, stains,
and broken or missing seals. Hold the base of the inner tray and peel the lid from the inner tray.
Verify that the serial number on the silver label matches with the shelf carton and implant data
card. In the event that there are any difference in serial number or size is noted, the valve
should be returned unused to Edwards Lifesciences. Please note that due to the dry storage feature of
the RESILIA tissue, the MITRIS valve does not require soaking. If the valve is rinsed prior
to implantation, it must then be kept hydrated with sterile physiological saline irrigation on
both sides of the leaflet tissue throughout the remainder of the surgical procedure.
Rinsing every 1 - 2 minutes is recommended. Remove the valve from the inner tray by
grabbing the dial. Do not try to insert the handle into the Dial at this point.
While holding the retainer, turn the dial clockwise to fold the valve commissure posts.
Turn the dial until the triangle on the dial is at the landing zone on the retainer and a hard stop
is felt. It s normal to hear a clicking noise. After stent posts are folded, remove the dial from
the holder system by pulling up on the dial. Next, attach the Model 1140M handle. To attach, align
the handle with the adapter on the valve holder and turn clockwise until resistance is felt.
To remove the retainer, hold the base of the handle and pull the retainer away by grasping
the ridge on the narrow edge of the retainer. The valve is now ready to be passed to the surgeon.
Prior to suturing the MITRIS RESILIA mitral valve, orient the valve such that the black A marking
aligns with the anterior portion of the mitral annulus, the single suture marker approximates the
posteromedial commissure, and the double suture marker approximates the anterolateral commissure.
Using these orientation aids, the third commissure stent post should naturally fall in place in or
around the middle of the posterior leaflet. MITRIS RESILIA mitral valve is usually implanted
using pledgeted mattress sutures, which can be placed with either an everting
or non-everting suturing technique. Place sutures through sewing cuff and
use the handle to facilitate parachuting and positioning of the valve on the mitral annulus.
Cut the retaining suture on the anterior side of the adapter with a scalpel in order to remove
the holder handle. Remove the handle,
tie the suture knots to secure the valve onto the annulus and cut the sutures above the knots.
Cut the retaining suture on the holder base at the single cut
point at the anterior side of the base. The single cut point contains three blue
polymer threads, ensure that all three blue polymer threads are cut to allow
the holder to be removed from the valve. This unfolds the commissure stent posts.
Use forceps or hemostat/clamps to grasp the blue component of the holder to remove the holder
and retaining sutures from the valve. MITRIS RESILIA valve is now implanted.