CONTAK RENEWAL™ 4 RF

Key Features

ZIP Wandless Telemetry
Enables wireless communication between the pulse generator and the programmer

• Eliminates the need for the wand in the sterile field, which may reduce the risk of infection
• Enables you to continue the implant procedure while the device is optimally programmed for your patient
• Provides faster data transmission speed, which means less time is required for device interrogation

Independent Channels
Independently programmable right ventricular (RV) and left ventricular (LV) pacing and sensing

• RV sensing is only used for tachyarrhythmia detection and RV pacing inhibition
• LV sensing is only used for LV pacing inhibition

High Energy Models

• High-energy models H217 (IS-1) and H219 (LV-1) offer 41 J stored energy.

Ventricular Rate Regulation (VRR)
Meant to reduce irregular ventricular intervals during conducted atrial arrhythmias

• Maximizes CRT delivery when programmed to the Maximum setting
• Only active during mode switch in tracking modes
• Available continuously in VVI(R) and DDI(R) modes
• Programmable: Off, Minimum, Medium, Maximum

Atrial Fibrillation (AF) in Heart Failure (HF) Patients

• The prevalence of AF increases as the severity HF increases.¹
• The incidence of AF in HF ranges from 10% to 50%. The highest incidence is in those with severe HF.²
• Patients with AF and severe HF experience a reduction in stroke volume, cardiac output and peak oxygen consumption.¹
• These patients have a reduction of approximately 20% in cardiac output.¹

IS-1 or LV-1 Left Ventricular Pace/Sense Lead Port

• Models H210 and H217 HE offer an IS-1 left ventricular pace/sense lead port
• Models H215 and H219 HE offer an LV-1 left ventricular pace/sense lead port

Left Ventricular Protection Period (LVPP)
Prevents pacing during the left ventricular vulnerable period (T-wave)

• LVPP is the period after a left ventricular event, either paced or sensed, when LV pacing is inhibited
• Programmable: 300-500 ms

Tracking Preference
Meant to maintain atrial-tracked ventricular pacing in DDD(R) and VDD(R) modes

• Temporarily reduces PVARP to reestablish atrial-tracked ventricular pacing inappropriately lost due to atrial events occurring in PVARP
• Programmable: On, Off

Patient-centric Diagnostics

Autonomic Balance Monitor
ABM is a device calculation based on R-R interval measurements and mathematically functions as a surrogate measurement for LF/HF ratio.

• LF/HF is considered a measure of sympathovagal balance and sympathetic modulations³

HRV Monitor Footprint
Measures changes in intrinsic heart rate and plots the distribution of variability versus heart rate over a 24-hour period

• Displays current footprint and one previously stored footprint to allow for comparison
• Heart rate is plotted on the X axis, variability is plotted on the Y axis, and frequency is plotted using color
• Shows a percentage for the total plot area covered by the footprint
• Vertical line indicates mean heart rate
• Increases in plot area indicate increases in heart rate variability (HRV) and/or heart rate range

HRV Monitor Trending
Plots heart rate (mean, minimum and maximum), HRV Monitor Footprint percentages, SDANN and ABM daily for 30 days and weekly for a 28 weeks

Activity Log
Plots the percent of day active for every day of the last 30 days and every week of the last 28 weeks

• Percent of day active is the percent of day the accelerometer-indicated motion is above a fixed minimal threshold

Mechanical Specifications

Model	Type	Size (cm) (H x W x D)	Mass (g)	Volume (cc)	Defibrillating Lead Ports	Atrial and Right Ventricular Pace/Sense Lead Ports	Left Ventricular Pace/Sense Lead Port
H210	DR	7.78 x 6.24 x 1.40	82	39	DF-1	IS-1	IS-1
H215	DR	7.78 x 6.24 x 1.40	82	39	DF-1	IS-1	LV-1
H217 (HE)	DR	8.26 x 6.60 x 1.40	90	43	DF-1	IS-1	IS-1
H219 (HE)	DR	8.26 x 6.60 x 1.40	90	43	DF-1	IS-1	LV-1

References

1. Maisel WH, Stevenson LW. Atrial fibrillation in heart failure: epidemiology, pathophysiciology, and rationale for therapy. Am J Cardiol. 2003;91(suppl):2D-8D.
2. The AF-CHF Trial Investigators. Rationale and design of a study assessing treatment strategies of atrial fibrillation in patients with heart failure: the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial. Am Heart J. 2002;144:597-607.
3. ACC/AHA guidelines for ambulatory electrocardiography. J Am Coll Cardiol. 1999;34:912-48.