Leads – ICM 09, ICM 09B, ICM 09JB

Model
ICM09
ICM09B
ICM09JB
Polarity
Unipolar
Bipolar
Bipolar
Shape
Straight
Straight
J-Shape
Chamber
Ventricle/Atrium
Ventricle/Atrium
Atrium
Fixation
4 tines
4 tines
4 tines

Material
Inner insulation
-
Silicone MED 4719
Silicone MED 4719
Outer insulation Polyurethane (55D) Polyurethane (55D) Polyurethane (55D)
Conductor
MP 35 N nickel alloy
MP 35 N nickel alloy
MP 35 N nickel alloy
Tip electrode
Titanium nitride
coated platinum alloy
Titanium nitride
coated platinum alloy
Titanium nitride
coated platinum alloy
Ring electrode
-
Titanium nitride
coated platinum alloy
Titanium nitride
coated platinum alloy

Body diameter 1.2 mm ( 3.5 F ) 1.8 mm (5.3 F ) 1.8 mm ( 5.3 F )

Introducer size
One lead
7 F
7 F
7 F
With guide wire
8 F
9 F
9 F

Tip/Ring distance
Tip/Ring distance - 17 mm 9mm

Electrode surface area
Tip
2.5 mm²
2.5 mm²
2.5 mm²
Ring
-
24 mm²
24 mm²

Coil resistance
Unipolar
40Ω (58 cm)
41Ω (58 cm)
37Ω (53 cm)
Bipolar
-
83Ω (58 cm)
51Ω (53 cm)
Steroid
< 1.0 mg
dexamethasone acetate and dexamethasone sodium phosphate
< 1.0 mg
dexamethasone acetate and dexamethasone sodium phosphate
< 1.0 mg
dexamethasone acetate and dexamethasone sodium phosphate
Standard lengths
52, 58, 65 cm
52, 58, 65 cm
45, 53 cm
Connector
IS-1 UNI
IS-1 BI
IS-1 BI
Serial number prefix
VMS
VMT
VMU

Crystalline

Indications, Contraindications, Warnings

Intended Use

Vitatron implantable transvenous leads are designed to be used with pulse generators as part of a cardiac pacing system. See product labeling for specific directions regarding application.

Contraindications

When tricuspid valvular disease is present, use of a transvenous ventricular lead is contraindicated. In patients with mechanical tricuspid heart valves, use of endocardial ventricular leads is contraindicated. Use of a passive fixation atrial lead may be contraindicated in the absence of a right atrial appendage. Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings

An implanted lead forms a direct, low-resistance current path to the myocardium. Therefore, use only battery-powered equipment during lead implantation and testing to protect against fibrillation caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Precautions

Use an anchoring sleeve with all leads. Leads should be handled with great care at all times. Any severe bending, kinking, stretching, handling with surgical instruments or excessive force when inserting a stylet may cause permanent damage to the lead. Chronic repositioning may adversely affect a steroid lead's low-threshold performance.

Potential Complications

The potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions that can occur when the lead is being inserted and/or repositioned: valve damage (particularly in fragile hearts, e.g., infants), fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis, and pneumothorax.