PERCEVALTM · 2019-07-25 · SIGNIFICANT TIME SAVINGS RESTORES AND PRESERVES NATURAL VALVE...

Optimizing the surgical approach to aortic valve replacement

PERCEVALAortic Pericardial Heart Valve

TM

SIGNIFICANT TIME SAVINGS

RESTORES AND PRESERVES NATURAL VALVE PERFORMANCE

• The collapsed profile minimizes trauma to the aortic wall while enabling a full and direct view

• Temporary guiding sutures ensure optimal placement

• 100% freedom from SVD at 5-year max follow-up1

CROSS CLAMP TIME REDUCTION VS. TRADITIONAL VALVES 2,3,4,5,6

61%3041

5578

References:

1. Shrestha et al; Eur J Cardiothoracic Surg 20152. Santarpino et al., Ann Thorac Surg 2013 Jul; 96(1):77-813. Phan et al., Ann Cardiothorac Surg 2225-319X.2014.06.014. Martens et al., Ann Thorac Surgery 2009;87:1914-85. Kocher et al., JCTS 2013;145(1):110-66. Folliguet et al., Ann Thorac Surg 2012;93:1483-87. Pollari et al; Ann Thorac Surg 2014;98:611–78. Gilmanov et al., Ann Thorac Surg 2013;96:2101-8

Traditional Sutured

3f Enable Medtronic

IntuityEdwards

Lifescience

Perceval

Isol

ated

AVR

C

ross

-Cla

mp

time

in m

inut

es (m

eans

)

BETTER PATIENT OUTCOMES 2, 7

REDUCES THE SURGICAL IMPACT

15

9.2

Hour

s (m

eans

)

Ventilation time reduction2

38%

1.9

Days

(mea

ns)

ICU stay reduction2

32%

2.81.1

PercevalTraditional Sutured

Bloo

d un

its (m

eans

)

Blood transfusion reduction2

52%

2.3

Traditional Sutured

Perceval

PercevalTraditional Sutured

ENGINEERED FOR PERFORMANCE

UNIQUE DESIGN AND ADVANCED ENGINEERING

OPTIMAL STRESS ABSORPTIONThe elastic structure of Perceval mimics the stress absorption properties of the native tissue at the valve commissures level. In addition, Perceval passed a test three times more rigorous than what is required by I.S.O. and F.D.A. guidelines.

ELASTIC CHAIN MODEL

SUPER ELASTIC STENTAllows Perceval to adapt to the natural movement of the aorta during the cardiac cycle

ATRAUMATIC COLLAPSING Allows for reduction in valve diameter while decreasing the chance for tears, perforation or folding

GEOMETRIC ORIFICE AREA IS MAXIMIZEDThe absence of a suturing ring provides excellent hemodynamic performance and stable results over time

Stent Pericardium Stress

OPTIMIZING THE SURGICAL APPROACH TO AORTIC VALVE REPLACEMENT

DESIGNED FOR ANY PATIENT THAT REQUIRES AN AVR INCLUDING COMPLEX CASES

Reproducible technique leading to shorter procedure and more reproducible results2,8

Improved outcomes that reduce post-operative complications

Sorin Group USA IncA wholly owned subsidiary of LivaNova Plc14401 W. 65th WayArvada, CO 80004 USATel. 800.289.5759Fax 877.657.3605e-mail: [email protected]

www.livanova.com

© 2016 LivaNova all rights reserved.

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

Manufactured by:LivaNova Canada Corp.5005 North Fraser WayBurnaby BC V5J5M1 - CanadaTel. 1-604-412-5650

IM-0

0529

/A

ICV1235Dual Collapser

ICV1242Dual Holder

ICV1148 Post-dilation Catheter

ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE

CODE AND LABEL CONTAINS


ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348

XL SternalICV1348 DEMOYYYY-MM-DD

(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A

Perceval SSingle Use Accessory Kit

SIZE

ICV1345 DEMOYYYY-MM-DD

(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A

Perceval SSingle Use MICS Accessory Kit

SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS


ICV1244Dual MICS Holder

ICV1216MICS Post-dilation Catheter

ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL

(!) inflation device is not included in single use accessory kit

14

SINGLE USE ACCESSORY KITPERCEVAL TM

PERCEVAL PRODUCT SPECIFICATIONSCODE DESCRIPTION PRODUCT USE

ICV

1208 Perceval size S

Single use1209 Perceval size M1210 Perceval size L1211 Perceval size XL

ICV 1268 Smart Clip Single use

ICV 1219 Sizers Kit Re-usable

ICV 1232 Dual Collapser Base Re-usable

ICV 1230 Accessories Tray Re-usable

SINGLE USE ACCESSORY KITS

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




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




STERNAL APPROACH MICS APPROACH

Size Code and Label

ICV1345

ICV1346

ICV1347

ICV1348

Contains ContainsCode and Label

ICV1349

ICV1350

ICV1351

ICV1352

S

M

L

XL


ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14



ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14



ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14



ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14



ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14

SINGLE USE ACCESSORY KITPERCEVAL TM ICV1235Dual Collapser

ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14



ICV1242Dual Holder


ICV1345

S Sternal

FORSURGICALAPPROACH

FORVALVESIZE



ICV1242Dual Holder


ICV1346

M Sternal


ICV1243Dual Holder


ICV1347

L Sternal


ICV1243Dual Holder


ICV1348


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1348 XL

E-0

081-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1345S

E-0

077-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1352 XL

E-0

087-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1351 L

E-0

086-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1347 L

E-0

080-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1346M

E-0

078-

02 2

015/

03/A


SIZE


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1349S

E-0

083-

02 2

015/

03/A


SIZE

MICS


(17)YYMMDD(10)DEMO

(01)080220570xxxxx(240)ICV1350M

E-0

084-

02 2

015/

03/A


SIZE

MICS




ICV1349

S MICS

FORSURGICALAPPROACH

FORVALVESIZE

CONTAINS




ICV1350

M MICS




ICV1351

L MICS




ICV1352

XL MICS

CODE AND LABEL


14


PERCEVALTM · 2019-07-25 · SIGNIFICANT TIME SAVINGS RESTORES AND PRESERVES NATURAL VALVE...

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Transcript of PERCEVALTM · 2019-07-25 · SIGNIFICANT TIME SAVINGS RESTORES AND PRESERVES NATURAL VALVE...