海思科介入式心脏瓣膜产品介绍

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P海思科海思科医疗器械2018年产品构成HAISCO

PHARMACEUTICAL

GROUP瓣膜输送系统交换系统交换液装载系统剂导引鞘回收系统瓣膜结构HAISCO

PHARMACEUTICAL

GROUP外层PET织物内层球囊牛心包瓣叶四个阀门心室侧主动脉侧工作原理HAISCO

PHARMACEUTICAL

GROUPAortic

RingVentricular

Ring位置导丝3中间阀装载阀尾阀位置导丝

1位置导丝2产品型号H

ISC PH

RM

CEUTIC GR

UP型号(mm)23252729瓣环19

-

2221-

24>24

-26>26

-28周长60

-

6966-

7775

-

8382

-

90主动脉侧环直径25272931心室环直径(周长-mm/面积-mm2)23(72/415)25(79/491)27(85/572)29(91/661)瓣环到主动脉环高度1515151623mm

Valve*25mm

Valve27mm

Valve29mm

Valve21222324242526262728产品特点HAISCO

PHARMACEUTICAL

GROUP一、 量金属支架（主要PET及尼龙，四个小金属阀门，金属不直接接触血液）二、可重新定位（瓣膜具有完全的功能后还可以根据结果来决定是否调整位置，如堵塞冠脉、位置过低影响传导束等）三、可回收（如果瓣膜型号选择不合适，或者其他特殊情况，可以完全回收瓣膜）四、高度仅有20mm左右，不影响以后冠脉的操作五、上下两个环状结构有效的防止了瓣国外临床回顾2011-2016CE

MarkJanuary

24,

2013IDE

ApprovalMay

16,

2013SALUS

FeasibilityApril

04,

2014SALUS

PivotalDISCOVER

RegistrySingle

arm;

N=503EnrolledClinical

TrialsDISCOVER

TrialSingle

arm;

N=100,EuroScore

≥

20Corelab

adjudicatedFU

to36-monthsEnrolledSALUS

Feasibility

TrialSingle

arm;

N=30,

ExtremeriskCorelab

adjudicatedEnrolledSALUS

Pivotal

TrialRandomized

2:1

(DFM

vs.

Sapien

3andCoreValve

EvolutR)

N=648Extreme

and

High

RiskEnrollingClinical

RegistrySALUSTranScatheter

AorticValveRepLacement

System

USDISCOVERDirect

Flow

Medical®

TranscatheterAortic

Valve

System

for

the

Treatmentof

Patients

with

Severe

Aortic

StenosisTCT

2016by

Azeem

LatibDirect

Flow

国际临床回顾Direct

Flow

MedicalEuropean

Experience

-

Clinical

OverviewBaseline

Characteristics:(N=100)Age

83.1

yrsEuroScore

22.5±11.3%DISCOVER

CE

Mark

TrialSingle

arm,

N=100EuroScore

≥

20Corelab

adjudicatedFU

up

to

5yrs36-month

FU

availableTCT

2016by

Azeem

Latib40%20%0%60%80%100%0360720

1080TCT

2016by

Azeem

LatibProbability

ofEvent-Free

Survival(%)3Years68.5%2Years81.1%The

DISCOVER

TrialFreedom

from

All-cause

Mortality30

Days99%1Year89.6%Days40%20%0%60%80%100%0360720

1080TCT

2016by

Azeem

LatibProbability

of

Event-Free

Survival(%)3Years63.4%2Years76.0%Days1Year84.5%30

Days95%The

DISCOVER

TrialFreedomfrom

All-cause

Mortality

and

Major

StrokeThe

DISCOVER

TrialMean

Pressure

Gradient

&

Effective45.213.313.70.661.481.500123020406080EOA

(cm2)Mean

Pressure

Gradient*

(mmHg)Orifice

AreaPaired

DataBaseline30D

–

D/C(latest

available)1–

3+

Years(latest

available)n=60n=79*

Full

Bernoulli

formulaTCT

2016by

Azeem

LatibThe

DISCOVER

Trial83%75%17%25%0%Paravalvular

AR

–

Paired

DataPaired

Data

(n=75)0%0%20%40%60%80%100%1–

3+

Years*Discharge

–

30D*None/Trace

Mild*

latest

available

follow-upModerateSevere

(None)TCT

2016by

Azeem

LatibThe

DISCOVER

TrialNYHA

Clinical

Improvement4%7%4%8%4%54%50%38%35%41%58%58%51%46%38%4%100%80%60%40%20%0%2year(N=71)3year(N=53)Baseline(N=97)Class

I30days(N=92)Class

II1year(N=81)Class

IIIClass

IVTCT

2016by

Azeem

LatibCan

the

DISCOVER

Data

beReproduced

in

the

Real

World?Real-World

ExperienceDISCOVER

Post-MarketStudySingle

armEnrolled

–

Interim

data

availableBaseline

Characteristics:

(n=375)Age

82.8

yrsEuroScore

18.2±13.6%TCT

2016by

Azeem

LatibDISCOVER

Registry

Locations0%60%40%20%80%100%97%(30d)90%(1

yr)92%(6

m)Kaplan-Meier

estimateat

risk:3520

30

60

90 120

150

180

210

240

270

300

330

360190

125The

DISCOVER

RegistryFreedom

from

cardiovascular

mortalityInterimysis

presented

by

F

DeMarco

TCT2015TCT

2016

by

AzeemLatibThe

DISCOVER

RegistryParavalvular

Leak16%2%4%10%85%82%100%80%60%40%20%0%30

D(n=

247)None/TraceMinimal/Mild1

Yr(n=115)Moderate

SevereInterimysis

presented

by

F

DeMarco

TCT2015

TCT

2016

by

Azeem

LatibDISCOVER

Trial

vs.

Registry30-Day

esA.

Colombo

–

The

DISCOVER

Trialresults

presented

at

EuroPCR

2015F.

De

Marco

-

The

DISCOVER

Post-Market

Registry

resultspresented

at

TCT

2015DISCOVER

TrialN=100DISCOVER

RegistryN=375Results

at

30

Days100806040200Freedom

fromMortalityFreedom

fromMortality

andStrokeMild

or

less

PVL

Major

VascularComplicationsNew

PPMTCT

2016

by

Azeem

LatibTVT

2014

by

CharlesDavidsonSALUS

Feasibility

TrialSALUS

Feasibility

TrialTVT

2014

by

Charles

DavidsonTVT

2014

by

Charles

DavidsonDirect

Flow

Medical

Valve

TechnologyApplicable

in

a

variety

of

clinical

situationses

persist

at

3-years

withExcellent

clinicalstable

hemodynamics>80%

of

patients

have

none-trace

PVL

at

30-des

in

real-worldCons