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Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study

Holger Hotz, CardioCentrum Berlin, Berlin, Germany;

Antonia Schulz, Cardiocentrum Berlin, Berlin, Germany; Jan Schmitto, Hannover Medical Sch, Hannover, Germany; Mirko Seidel, Unfallkrankenhaus Berlin, Berlin, Germany; Thomas Krabatsch,

Deutsches Herzzentrum Berlin, Berlin, Germany

American Heart Association Meeting

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Disclosures

H. Hotz: NoneA. Schulz: None J. Schmitto: None M. Seidel: None T. Krabatsch: None

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Sunshine Heart, Inc. is sponsoring the OPTIONS HF Clinical Trial. It is a post market, multi-center surveillance study with up to 15 centers participating throughout Europe. Up to 50 patients will be implanted in the study and be followed up to 5 years.

OPTIONS HF Clinical Study

X Ascending aortic calcification or CABGX Mitral Valve Incompetence, Grade 4+

X Aortic Valve Incompetence, Grade 2 - 4+

X Patient has systolic blood pressure less than 90 or greater than 140 mm Hg

√ NYHA Class III and Ambulatory Class IV√ On optimal medical therapy and remains symptomatic√ Had been evaluated for or have CRT or CRT-D therapy and remain symptomatic or ICD therapy (narrow QRS)√ 6MHW 175 - 375 m√ At least one hospitalization for decompensated HF, while on HF medications, OR BNP level > 300 or NTproBNP > 1500 within 12 months prior to randomization√ Both ischemic and non-ischemic

Key Study Qualifications:

Study Objective: The study is designed to observe the clinical outcomes of heart failure patients treated with the C-Pulse® System in the usual manner and according to the approved indications and contraindications.

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A minimally invasive, non-blood contacting, counter-pulsation heart assist therapy for the treatment of moderate to severe heart failure.

• Reduce LV work, increase flow• Balloon inflates – increases coronary

perfusion (addresses hemodynamics - primary pathophysiology of heart failure)

• Balloon deflates – decrease afterload• Minimally invasive procedure can be

performed in 90 minutes • No blood contact – lower likelihood of clot

or stroke• Ability to disconnect – patient comfort and

convenience

The C-Pulse® System

Extra-Aortic Cuff

ECG Sensing Lead

Driver

Percutaneous Interface Lead

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  All Patients (N=8)Mean ±SD (range) Age (in years)

60.8 ± 10.5 (51, 79)

Gender Male 87.5% (7/8) Female 12.5% (1/8)Co-morbidities Arrhythmia 50% (4/8) Diabetes Mellitus 62.5% (5/8) Smoking history 87.5% (7/8) Cardiomyopathy 100% (8/8) - Ischemic 50% (4/8) - Non-Ischemic 50% (4/8)INTERMACS Profile 4: Resting symptoms 37.5% (3/8) 5: Exertion Intolerant 37.5% (3/8) 6: Exertion Limited 25% (2/8)NYHA Class III 87.5% (7/8) IV 12.5% (1/8)CRT 62.5% (5/8)ICD Therapy 75.0% (6/8)

Methods

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• 8/8 (100%) of patients successfully implanted

• No procedural device-related complications

• CPB used in 1 patient with concomitant CABG

• No stroke, myocardial infarction, major bleeding or major infection were reported due to the device through 6 months

• One patient was weaned off the device after 6 months of support and showed an increase in EF from 20% at baseline to 44% at 6-months

• One patient developed non-device related refractory tachycardia with worsening heart failure 12 hours after surgery which prevented C-Pulse from supporting the heart properly resulting in subsequent VAD implant 5 days after the index procedure

Results

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0%

20%

40%

60%

80%

100%

I II III

IV

BaselineN=4

6 months

N=4

Results: NYHA – 6 Months

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0

100

200

300

Baseline

N=4

6 months

N=4

260.5 ± 77

Results: 6MWT – 6 Months

203.3 ± 25

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0

10

20

30

40

50

25 ± 7.9

43.3 ± 4.9

Baseline

N=4

6 months

N=4

Results: LVEF (%) – 6 Months

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Conclusion

• Preliminary results from this small cohort in the European Option HF post-market study demonstrate safety of implantation of the C-Pulse System

• 6 month results show improvements in functional capacity and physician assessed functional status

• Efficacy also demonstrated in cardiac remodeling

• C-Pulse Heart Assist System is a promising therapeutic option for patients with moderate to severe heart failure