Aortic Pericardial Heart Valve

Reducing the impact of surgery and facilitating faster recovery

PERCEVALTM

THE BIOLOGICAL VALVE OF CHOICE IN AVR

A TRULY SUTURELESS SOLUTION IN AVRPerceval helps reducing complexity even in challenging and time consuming procedures1,2

WITH REPRODUCIBLE SURGICAL TECHNIQUEPerceval allows precise positioning both in MICS and traditional surgery2,3

AT YOUR SIDE IN EVERY DAY PRACTICEPerceval is a valuable option to reduce post-operative complications1,2

CROSS CLAMP TIME REDUCTION VS. TRADITIONAL VALVES 4,5,6,7

61%3041

5578

Traditional Sutured

3f Enable Medtronic

IntuityEdwards

Lifescience

Perceval

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ated

AVR

C

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-Cla

mp

time

in m

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)

REDUCING THE PHYSIOLOGICAL IMPACT OF THE OPERATION

“Atraumatic insertion of the device with self-anchoring of the prosthetic valve into its final position, minimizing the risk for iatrogenic aortic dissection or thromboembolic stroke” 1

INCREASED VISUALIZATIONThe reduced collapsed profile avoids any trauma to the aortic wall enabling a full and direct view.

PRECISE POSITIONINGThe temporary guiding sutures allow to parachute the valve by guiding it along the annulus axis even in narrow spaces.

EASE OF IMPLANTTraditional valves require from 15 to 18 permanent sutures. Perceval is a truly sutureless valve.

BETTER PATIENT OUTCOMEREDUCES THE SURGICAL IMPACT

15

9.2

Hour

s (m

eans

)

Ventilation time reduction1

38%

PercevalTraditional Sutured

1.9

Days

(mea

ns)

ICU stay reduction1

32%

2.8

Traditional Sutured

Perceval

1.1PercevalTraditional

Sutured

Bloo

d un

its (m

eans

)

Blood transfusion reduction1

52%

2.3

A distinctive design built around a SUPER ELASTIC STENT with unique features and mechanical behavior.

FOLLOWING HEART MOVEMENT The Perceval stent is able to adapt to the movements of the aorta during the cardiac cycle.

INNOVATION STARTS AT ITS CORE

OPTIMIZED BLOOD FLOWThe geometric orifice area is maximized, thanks to the absence of a suturing ring8 providing excellent hemodynamic with stable results over time.

8.78.910.4

Discharge 3-6 Months 1-4 Years

Mea

n gr

adie

nts

in m

mH

g

Find out more:1. Santarpino et al., Ann Thorac Surg 2013 Jul; 96(1):77-812. Santarpino et al., Ann Thorac Surg 2012;94:5043. Gilmanov et al., Ann Thorac Surg 2013;96:2101-84. Phan et al., Ann Cardiothorac Surg 2225-319X.2014.06.01

5. Martens et al., Ann Thorac Surgery 2009;87:1914-86. Kocher et al., JCTS 2013;145(1):110-67. Folliguet et al., Ann Thorac Surg 2012;93:1483-8 8. Shrestha et al., Interactive CardioVascular and Thoracic Surgery (2013) 1-5

A DESIGN CONCEIVED TO ENHANCE DURABILITY

ELASTIC CHAIN MODELPericardium Stent Stress

OPTIMAL STRESS ABSORPTIONThe elastic structure aims at reproducing the stress absorption properties of the native tissue at the valve commissures level.

Did you know that…

The Perceval valve showed in-vitro durability much higher than required by the ISO standard and FDA Guidance. In fact, the durability testing was continued beyond 600 million cycles, with the maximum durability over 2 billion cycles.

This Perceval valve showed no failure after 2 Billion cycles, equivalent to 50-year heart cycles in-vivo.

PERCEVAL TM

The Perceval tissue component is based on a double sheet design introduced by Sorin in 1985 which has shown excellent results in terms of durability 1,2

Find out more:1. Folliguet et al., Ann Thorac Surg 2001;71:S289-922. D’Onofrio et al., J Thorac Cardiovasc Surg 2007;134:491-53. Della Barbera et al., Abstracts/ Cardiovascular pathology 22 (2013)

Examination of the results after collapsing and deployment revealed optimal cusp coaptation and absence of tears, perforation or folding.3

Source: M. Della Barbera SHVD 2011 poster presentation

Collapsing:

• Increases the visibility• Allows easier procedure• Preserves the integrity of the leaflets

NO COLLAPSE

Pericardical Cusps: scanning electron microscopy. Elastic Van Gieson and Sirius Red stain at polarized light: collagen waviness in control and at different times of collapse.

15 min COLLAPSE 60 min COLLAPSE 180 min COLLAPSE

INNOVATION AND HERITAGE

COLLAPSING, NOT CRIMPING

PERCEVAL TM

Sorin Group Italia Srla wholly-owned subsidiary of LivaNova PLCVia Crescentino13040 Saluggia (VC) ItaliaTel +39 0161 487472 · Fax +39 0161 487316info.cardiacsurgery@livanova.com

Manufactured by:

Sorin Group Italia S.r.l.A wholly-owned subsidiary of LivaNova PLCFor LivaNova Canada Corp. 5005 North Fraser WayBurnaby B.C. V5J 5M1Canada

RE02

1008

5/F

Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects.

© 2016 LivaNova all rights reserved.

www.livanova.com

PRODUCT SPECIFICATIONSCODE DESCRIPTION PICTURE USE

ICV

1208 Perceval size S

Single use1209 Perceval size M

1210 Perceval size L

1211 Perceval size XL

0218TS Inflation Device Single use

ICV 1219 Sizers kit Re-usable

ICV 1232 Dual Collapser Base Re-usable

ICV 1268 Smart Clip Single use

STERNAL APPROACHSIZE KIT CODE CODE AND LABEL

S

ICV1345 ICV1235: Dual CollapserICV1242: Dual HolderICV1148: Post-dilation Catheter

M

ICV1346 ICV1235: Dual CollapserICV1242: Dual HolderICV1149: Post-dilation Catheter

L

ICV1347 ICV1236: Dual CollapserICV1243: Dual HolderICV1170: Post-dilation Catheter

XL

ICV1348 ICV1236: Dual CollapserICV1243: Dual HolderICV1234: Post-dilation Catheter

MICS APPROACHSIZE KIT CODE CONTAINS

S

ICV1349 ICV1235: Dual CollapserICV1244: Dual MICS HolderICV1216: MICS Post-dilation Catheter

M

ICV1350 ICV1235: Dual CollapserICV1244: Dual MICS HolderICV1217: MICS Post-dilation Catheter

L

ICV1351 ICV1236: Dual CollapserICV1245: Dual MICS HolderICV1218: MICS Post-dilation Catheter

XL

ICV1352 ICV1236: Dual CollapserICV1245: Dual MICS HolderICV1241: MICS Post-dilation Catheter

SINGLE USE ACCESSORY KITS