Edwards SAPIEN XT • Transcatheter Heart Valve with the NovaFlex Transfemoral Kit • Válvula cardíaca transcatéter con el kit transfemoral NovaFlex • Válvula Cardíaca Transcateter com o Kit Transfemoral NovaFlex 1.0 Device Description DIRECTORY

• Edwards SAPIEN XT Transcatheter Heart Valve (Figure 1) The Edwards SAPIEN XT transcatheter heart valve (THV or bioprosthesis) is comprised of a balloon-expandable, radiopaque, cobalt chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET) fabric. It is treated according to the Edwards ThermaFix process, and is packaged and terminally sterilized in glutaraldehyde. The THV is intended to be implanted in a native annulus size range comparable to the following transesophageal echocardiography (TEE) measurements:

English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Figures / Figuras . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20–21 Symbol Legend / Inscripción de símbolos / Legenda do Símbolo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Native Valve Annulus Size

Bioprosthesis Size

18–22 mm

23 mm

21–25 mm

26 mm

English

Instructions For Use

• Qualcrimp Crimping Accessory (Figure 2) The Qualcrimp crimping accessory (packaged with the NovaFlex delivery system) is used during crimping of the THV. • NovaFlex Delivery System (Figures 3a, 3b, 3c) The NovaFlex delivery system includes a handle that provides a Flex Wheel for articulation of the Flex Catheter, a tapered tip at the distal end of the delivery system to facilitate crossing the native valve, and a Balloon Catheter for deployment of the THV. The handle contains a Flex Indicator that shows whether or not the Flex Catheter is articulated, a Valve Alignment Wheel for fine adjustment of the THV during Valve Alignment, a Press/Release Button that enables movement between handle positions, and a flush port to flush the Flex Catheter. The Balloon Catheter has radiopaque Valve Alignment Markers defining the Valve Alignment Position and the working length of the balloon. A radiopaque Double Marker proximal to the balloon indicates the Flex Catheter position during deployment. The inflation parameters for THV deployment are:

Physicians Training Requirement: Implantation of transcatheter heart valves shall be performed by physicians who have received Edwards Lifesciences training. The implanting physician should be experienced in balloon aortic valvuloplasty.

Product Name

23 mm System 26 mm System (9350NF23) (9350NF26) Model/REF

NovaFlex Transfemoral Kit, comprised of the following: Edwards SAPIEN XT Transcatheter Heart Valve

9300TFX (23 mm)

9300TFX (26 mm)

NovaFlex Delivery System[1]

9350FS23

9350FS26

NovaFlex Introducer Sheath Set

9350S23

9350S26

RetroFlex Dilator Kit

9100DKS

RetroFlex Balloon Catheter

9120BC20

9120BC23

Crimper

9340CR23

9340CR26

Atrion QL2530 Inflation Device [1]

96402

Includes the Qualcrimp Crimping Accessory, 9300QC

Model

Nominal Balloon Diameter

Nominal Inflation Volume

Rated Burst Pressure (RBP)

9350FS23

23 mm

17 ml

7 atm (709 kPa)

9350FS26

26 mm

22 ml

7 atm (709 kPa)

• NovaFlex Introducer Sheath Set (Figure 4) The NovaFlex introducer sheath set contains: a) an introducer with a hydrophilic coating to facilitate introduction and trackability of the sheath into the vessel,

Edwards Lifesciences, the stylized E logo, Edwards, Edwards SAPIEN XT, NovaFlex, Qualcrimp, RetroFlex and ThermaFix are trademarks of Edwards Lifesciences Corporation; Edwards Lifesciences, the stylized E logo, RetroFlex and ThermaFix are registered in the U.S. Patent and Trademark Office. Atrion is a registered trademark of Atrion Medical Products, Inc.

1

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significant aortic tortuosity or disease including abdominal aortic or thoracic aneurysm; • ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity; • significant atheroma of the femoral and iliac vessels; • femoro-iliac vessels