ccm therapy - impulse dynamics

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Separation > 2 cm High Septal – Near RVOT (V) RV Outflow Tract Mid RV Septum (LS) 69.4 mm 47.5 mm 11.5 mm 30.5 cc The Optimizer ® Smart is a minimally invasive, implantable device that delivers a proprietary therapy called CCM™ to patients with chronic heart failure. CCM™ therapy has been designed to improve overall heart function, and quality of life for patients. CCM™ is also known as Cardiac Contractility Modulation CCM THERAPY OPTIMIZER ® SMART with the BRINGING HOPE TO PATIENTS WITH HEART FAILURE WHO For patients with: • LVEF 25–45% • NYHA Class III • Symptomatic despite guideline directed medical therapy • In normal sinus rhythm • Not indicated for Cardiac Resynchronization Therapy WHAT The Optimizer ® Smart delivers CCM™ therapy, which: • Applies non-excitatory electrical signals to the RV septum during the absolute refractory period using standard leads • Improves NYHA functional status, 6-minute hall walk distance and QoL status • Has rapid, intermediate and long-term effects Optimizer ® Smart Implant

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Page 1: CCM THERAPY - Impulse Dynamics

Separation > 2 cm

High Septal –Near RVOT (V)

RV Outflow Tract

Mid RVSeptum (LS)

69.4 mm

47.5 mm 11.5 mm

30.5 cc

The Optimizer® Smart is a minimally invasive, implantable device that delivers a proprietary therapy called CCM™ to patients with chronic heart failure. CCM™ therapy has been designed to improve overall heart function, and quality of life for patients.

CCM™ is also known as Cardiac Contractility Modulation

CCM™ THERAPY

OPTIMIZER® SMARTwith the

BRINGING HOPE TO PATIENTS WITH HEART FAILURE

WHOFor patients with:

• LVEF 25–45%

• NYHA Class III

• Symptomatic despite guideline directed medical therapy

• In normal sinus rhythm

• Not indicated for Cardiac Resynchronization Therapy

WHATThe Optimizer® Smart delivers CCM™ therapy, which:

• Applies non-excitatory electrical signals to the RV septum during the absolute refractory period using standard leads

• Improves NYHA functional status, 6-minute hall walk distance and QoL status

• Has rapid, intermediate and long-term effects

Optimizer® Smart Implant

Page 2: CCM THERAPY - Impulse Dynamics

24 Hour Therapy Clock

HOWThe Optimizer® Smart delivers CCM™ therapy in five one-hour therapy delivery phases separated by 3.8-hour rest periods1

• Device recharged weekly for one-hour period

• Device longevity 15 years

Patient EKG During CCM™ Therapy

12AM

12PM

6PM 6AM

1

1

3.8

3.8

3.8

3.8

3.8

1

1

1

CCM™ waveform is biphasic, with duration ~ 20 ms and amplitude ± 7.5 V. Therapy is never delivered on T wave.

The Optimizer® Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India and more than 40 other countries around the world.

© Impulse Dynamics. All rights reserved.

1 Campbell CM, Kahwash R, & Abraham WT. Optimizer Smart in the treatment of moderate-to-severe chronic heart failure. FutureCardiol. 16(1), 13–25 (2020) ID-A140-US Rev 00

Indications for Use: The Optimizer® Smart System, which delivers CCM™ therapy, is indicated to improve 6 minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25% to 45%.

For more information, visit our website at impulse-dynamics.com or contact us at 856–642–9933.

• Local electrotonic spread of signal

• Rapid phosphorylati-on of key proteins

• Improved calcium cycling and contractile force

• No increased myocardial oxygen consumption

Rapid

MINUTES TO HOURS• Shift of gene

program from heart failure to normal

• Local effects improve contraction at global level

Intermediate

HOURS TO WEEKS• Beneficial effect on

global ventricular properties and reverse remodeling

Long-Term

WEEKS TO MONTHS

±7.5 V

~30 ms

R

RR

PT

Q SQ S

CCM™ Signal

QRS w CCM™Normal QRS

20 ms duration

PT