Defibrillator leads

OmniaSecure™ defibrillation lead

<p>The lumenless OmniaSecure™ lead is 4.7 French and enables precise lead placement in the right ventricle (RV), inclusive of left bundle branch area (LBBA).</p>

Ordering information

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Indications, Safety, and WarningsIndicationsThe Model 3930M family of leads are intended for use in the right ventricle (RV) or for placement in the left bundle branch area as an alternative to right ventricular stimulation sensing, pacing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening tachyarrhythmias.This includes adolescent pediatric patients who are at least 30 kg and are also at least 12 years of age, and whose cardiac anatomy is conducive to RV coil placement.ContraindicationsThe Model 3930M family of leads are contraindicated for use in the following situations:

Non-right ventricular use – The lead is contraindicated for non-right ventricular implant sites including the His bundle and the atrial side of the tricuspid valve annulus.

Tricuspid valvular disease or mechanical tricuspid valve – The lead is contraindicated in patients with tricuspid valvular disease or a mechanical tricuspid valve.

Steroid use – The lead is contraindicated in patients for whom a single dose of 1.0 mg of dexamethasone acetate may be contraindicated.

Transient ventricular tachyarrhythmias –The lead is contraindicated if tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, sepsis.

Intravenous Catheterization – The leads are contraindicated in patients with obstructed or inadequate vasculature for intravenous catheterization.

Warnings and PrecautionsHandling the lead – Handle the lead with care at all times. Do not implant the lead if it is damaged. Do not attempt to straighten or realign the helix if the helix is deformed. Return the lead to your Medtronic representative in either event.Repositioning or removal of an acute lead – Successfully repositioning the lead depends on recreating the angle and advancement of the catheter present at the time of initial helix deployment at implant (relative to the lead helix and endocardium). Proper orientation helps transfer torque to the helix. This increases the likelihood of successfully disengaging the helix from the endocardium. Improper removal of the lead by pulling may result in avulsion of the endocardium.Extraction or removal of a chronic lead – Proceed with caution if a chronically implanted lead must be removed or extracted. Lead extraction procedures should be consistent with the most recent editions of HRS or EHRA expert consensus statements regarding cardiovascular implantable electrode device lead management and extraction. Market released extraction tools or clinically recognized techniques may be used to help facilitate extraction. When the risk of lead extraction outweighs the benefit, it may be preferable to abandon unused leads and leave in place. Return all removed leads, unused leads, or lead sections to Medtronic for analysis.Connector compatibility – Although Medtronic lead connectors conform to International Connector Standards, this lead has not been tested for use with non-Medtronic devices. The known potential adverse consequences of using such a combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection.Electrophysiologic testing – Electrophysiologic evaluation and testing should be performed at the discretion of the physician taking into consideration the current clinical guidelines.Potential Adverse EventsThe following are known potential complications associated with the use of this product: Allergic reaction; AV fistula; Bradyarrhythmia; Cardiac arrest; Cardiac inflammation; Cardiac perforation; Cardiac tamponade; Cardiac valve damage; Discomfort; Dislodgement; Dizziness; Dyspnea; Embolism; Erosion; Extracardiac stimulation; Excessive fibrotic tissue growth; Fever; Heart block; Heart failure decompensation (hospitalization); Hematoma; Hemorrhage; Hemothorax; Hiccups; Hospitalization; Inappropriate shock; Infection; Insulation failure; Lead fracture; Lethargy; Loss of capture; Loss of pacing; Mental anguish; Nerve damage; Oversensing; Palpitations; Pericardial effusion; Pneumothorax; Return of cardiac symptoms; Septal wall perforation; Seroma; Skeletal muscle sensation or twitching; Skin disorders; Stroke; SVC tear; Syncope; Tachyarrhythmia; Threshold elevation; Thrombosis; Tissue trauma; Toxic reaction; Tricuspid valve regurgitation; Undersensing; Vascular tear; Venous occlusion; Vessel perforation.See the MRI SureScan Technical Manual before performing an MRI scan. Consult Lead Technical Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.US-CV-2600618 v1.0

Product details

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Learn more about the OmniaSecure™ defibrillation lead.

This is a close-up view of the OmniaSecure™ defibrillation lead stress test to ensure durability at implantation with green decorative elements behind it.

Built for high reliability

Durable, lumenless construction

Built on the proven SelectSecure™ 3830 pacing lead platform^1,2
High projected 10-year fracture-free rate, based on comprehensive, robust benchtop testing^3,4

Reliable therapy delivery

High defibrillation efficacy at implant^1,5
Stable electricals (sensing, pacing, impedance) through follow-up^6,7

This is an illustration showing how the OmniaSecure™ defibrillation lead is implanted into the heart with green decorative elements behind it.

Implant with precision

FDA approved for LBBAP in both adults and adolescent pediatric populations
High implant success for standard RV and for LBBAP with ICD and LOT-CRT applications^1,5
Lumenless design supported by a comprehensive suite of catheters to support precise placement

This is an image of the OmniaSecure™ defibrillation lead with green decorative elements behind it.

The world’s smallest defibrillation lead

Lumenless, 4.7 French, 64% smaller than Sprint Quattro™ defibrillator lead⁸
May reduce potential lead-related complications, such as vascular occlusion or tricuspid valve complications^9–11
Smaller leads are projected to reduce worsening of tricuspid regurgitation compared to larger leads¹²

Clinical evidence

OmniaSecure™ LEADR Global Pivotal Trial

The OmniaSecure™ lead has demonstrated high defibrillation success, low complications, and reliable therapy delivery in the LEADR Global Pivotal Trial through three years.

View the manuscript (open in new window)

96.5%

freedom from OmniaSecure™ lead-related major complications at three years

Primary safety objective met, exceeding performance goal, and in line with industry reports⁵

97.5%

defibrillation efficacy
at implant

Primary objective passed, exceeding performance goal, and in line with industry reports¹

99.8%

clinical fracture-free survival at three years
(32.4 ± 9.1 months)

Reliable performance and high durability consistent with reliability modeling through three years⁵

Cardiac lead reliability model — OmniaSecure™ defibrillation lead 10-year results

The novel, small-diameter OmniaSecure™ lead is predicted to be highly durable with an overall 98.2% fracture-free rate at 10 years, inclusive of adolescent pediatric population.³

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OmniaSecure™ LEADR LBBAP Global Trial

The OmniaSecure™ lead demonstrated high defibrillation success and low complication rate when placed in the LBBA.

96.8%

freedom from lead-related major complications at one year

Primary safety objective met, exceeding performance goal⁷

100%

defibrillation efficacy
at implant

Primary objective passed, exceeding performance goal⁶

Zero

fractures at one year

Reliable performance with stable pacing, sensing, and impedance⁷

Specifications

This is an illustration of the OmniaSecure™ defibrillation lead with numbered callouts.

1. 4.7 Fr lead body

2. DF4 connector

3. Fixed helix

4. Steroid-eluting MCRD ring

5. Defibrillation coil

6. Integrated bipolar sensing

7. Conductor cable: MP35N

8. Inner insulation: ETFE

9. Inner insulation: silicone

10. Conductor coil: silver cored MP35N

11. Conductor coil insulation: SI polyimide

12. Outer insulation: 55D polyurethane

Implant procedure

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Ordering information

Item number	Type	Fixation	Connector	MR Conditional length (cm)	Diameter (Fr)
3930M64	Single coil, bipolar	Helix, active fixation	DF4	64	4.7
3930M69	Single coil, bipolar	Helix, active fixation	DF4	69	4.7
3930M74	Single coil, bipolar	Helix, active fixation	DF4	74	4.7
3930M79	Single coil, bipolar	Helix, active fixation	DF4	79	4.7
3930M84	Single coil, bipolar	Helix, active fixation	DF4	84	4.7