New TAVR Technology: J-ValveTM Ausper System

Anson Cheung, MD

Clinical Professor of Surgery

St. Paul’s Hospital

University of British Columbia

Vancouver, Canada

• Consulting Fees/Honoraria

• Major Stock Shareholder/Equity

• St. Jude Medical• HeartWare Inc• Abiomed Inc• Edwards LifeSciences

• Kardium Medical• Entourage Medical• Neovasc Inc

Within the past 12 months, I or my spouse/partner have had a

financial interest/arrangement or affiliation with the organization(s)

listed below.

Affiliation/Financial Relationship Company

Disclosures

JC Medical - J-ValveTM Ausper System

• Second generation Transapical TAVR system

• Nitinol based, self-expanding valve stent

• Porcine aortic valve

• Clasper – independently operated 3D ring that corresponding to the native sinuses, orients the valve stent and capturing the native leaflets

• 27F sheathless delivery catheter with a flexible tip

JC Medical – J ValveTM

JC Medical - J-Valve TAVR System

• 4 sizes (21, 23, 25 and 27) – Annular range of 19 to 27mm

• Unique mechanism

• Able to treat patient with AS and AI

Courtesy of Dr. Y. Guo

Clinical Experience with

J-Valve Ausper System

• FIM implant at West China Hospital in Chengdu,

China by Dr. Yingqiang Guo in March 2014

• Chinese SFDA regulatory trial completed

March 2014 to July 2015

107 patients with severe symptomatic AS or AR

J•Valve™ Ausper System China Study

• Study Design:

Prospective, multi-center, observational study

• Primary Endpoint:

Mortality rate from all causes 30 days after surgery

• Secondary Endpoint:

Improvement of cardiac function, NYHA functional

classification at 30 days, 6 months, and 12 months

• Inclusions:

High risk symptomatic patients with AS or AR

EuroSCORE > 20%

Patient Demographics

Characteristics

Number of Patients Enrolled 107

Age 74.4 （61-87）

Male 54%

Logistic EuroSCORE 27.5% （20-63.2）

Annular Size 22.5 mm (17-27)

NYHA Class III or IV 97.2%

Aortic Stenosis 59.8%

Aortic Insufficiency 40.2%

Patient Pre-operative Characteristics

Number (%)

Hypertension 63.6%

Diabetes 15.0%

CAD 18.7%

COPD 55.1%

Atrial Fibrillation 19.6%

Congestive heart failure 25.2%

Peripheral vascular disease 52.3%

Stroke/TIA last 3 months 6.5%

Device Success

Number of Patients 107

Procedural Mortality 0

Incorrect Positioning 5

Second Valve Implanted 2

Conversion to Surgery 5

Device Success Rate: 93.5%

Clinical Outcomes

30 day

(n=107 )

All-cause Mortality 4.7%

MI 0%

Urgent cardiac surgery or repeat

intervention0.9%

Stroke 0%

New Pacemaker 2.8%

Major adverse cardiovascular and cerebrovascular events (MACCE)1defined as any emergency surgical or transapical catheter intervention procedures that

repair, otherwise alter, adjusts, or replaces a previously implanted valve

0

20

40

60

80

100

120

Pre-OperationITT

Treated

Nu

mb

er

of

pat

ien

ts

I II

III IV

30 days Post-op

Clinical Outcomes-NYHA

Mean Aortic Gradient – AS vs AI

Perivalvular Leak (PVL)

ITT: Intend to treat

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pre-Implant 30 Day

Severe

Moderate

Mild

Trivial

None

J-Valve in AI patients (N=33)

Clinical Factors

Age 74.2± 5.2

Female Gender 21%

Weight 52.3 ± 7.6 kg

Peripheral Vascular disease 36%

COPD 55%

Prior Cerebrovascular disease 36%

NYHA Class II 18%

III 52%

IV 30%

Logistic EuroSCORE I 24.4 ± 5.1%

LVEF < 50% 42%

Mean gradient 10.0 ± 5.7 mmHg

AR Grade III 21%

Grade IV 79%

J-Valve in AR patients (N=33)VARC-2 Defined Endpoints

Cerebrovascular event 0

Myocardium infraction 0

Access site complication

Minor 3%

Major 0%

Paravalvular leakage (>2+) 3%

Acute kidney injury 3%

Permanent pacemaker implantation 6%

ICU stay (days) 2 ± 1

In-hospital stay (days) 12 ± 4

Device success 97%

All-caused mortality 3%

Cardiac mortality 3%

Degree of Aortic Regurgitation

0%

25%

50%

75%

100%

Pre Implant 30 Day 6 Month

Severe

Moderate

Mild

Trace

None

N=33 N=31 N=31

Summary

• J-ValveTM Ausper system is a 2nd generation

TAVR system with unique mechanism

• Able to treat patients with AS or AI

• Excellent device, clinical success and

performance, especially in AR patients

Future Direction

• Preparing CE Mark submission

• Planning stage for US IDE trial

• Retrograde delivery systems in development

Discussions