Attain Left-Heart Leads
Medtronic offers a broad choice of leads to navigate diverse anatomies to enhance the chance of success during the implant procedure. Designs are available for stability in different vein sizes and programming options to avoid phrenic nerve stimulation.
Medtronic Provides More Options for Left-Heart Leads than Any Other Company, Improving Chances of Implant Success1
Detail – Attain Lead Options
Detail Attain Lead Family Vein Diameter Continuum
Attain® Family of LV Leads |
|||||
|---|---|---|---|---|---|
| 4194 | 4195 | 4196 | 4296 | 4396 | |
| Compatibility | IS-1 | IS-1 | IS-1 | IS-1 | IS-1 |
| OTW Delivery | Yes | Yes | Yes | Yes | Yes |
| Stylet Delivery | Yes | Yes | Yes | Yes | Yes |
| Distal Lead Diameter | 5.4 Fr | 5.3 Fr | 4.6 Fr | 4.6 Fr | 4.6 Fr |
| Proximal Lead Diameter | 6.0 Fr | 5.0 Fr | 4.0 Fr | 5.3 Fr | 4.0 Fr |
| Tip Seal | Yes | Yes | Yes | Yes | Yes |
| Distal Shape | Angled | Canted | Angled | Angled | Straight |
| Fixation | Angled Body | Deployable Lobes | Dual Canted | Dual Canted | Tined Fixation |
| Polarity | Bipolar | Unipolar | Bipolar | Bipolar | Bipolar |
| Distal ESA | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 |
| Proximal ESA | 38.0 mm2 | NA | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 |
| Electrode Separation | 11.0 mm | NA | 21.0 mm | 21.0 mm | 21.0 mm |
| Lead Lengths | 78, 88 cm | 78, 88, 103 cm | 78, 88 cm | 78, 88 cm | 78, 88 cm |
| Compatible with Select II Sub-Selection Catheter | No | No | Yes | Yes | Yes |
Reference
- Medtronic is the only medical device company to offer an active fixation LV lead and hybrid guide wire. Sources consulted: January 2011: www.bostonscientific.com; www.sjm.com; www.biotronik.com; www.sorin-crm.com.
Attain Ability Left-Heart Lead –
4196 4 Fr, Dual Electrode
The first 4 Fr dual electrode* left-heart lead featuring a flexible, tapered distal end for navigating difficult anatomies. Compatible with Select® II sub-selection catheters.
Attain Ability® 4196 Lead
Delivery Flexibility
The Attain Ability 4196 lead can be delivered with a guide wire or stylet. Compatible with:
- Attain Command® catheters, the first family of catheters to feature a hydrophilic coating
- Attain Select® II sub-selection catheters, enabling direct-to-vessel delivery for deep seating in difficult anatomies (in leads ≥ 88 cm length)
- Attain Hybrid® guide wire (GWR 4196), proven to reduce implantation time and improve access to target vein LV lead positioning1
Important Safety Information
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Key Features
- Dual electrode*
- Dual canted fixation for enhanced stability
- Steroid on both electrodes
- 4.0 Fr proximal lead diameter
- IS-1 connector
- Multiple pacing vectors help address phrenic nerve stimulation and prevent need for chronic electrode repositioning
- Ability to choose the best configuration for threshold optimization during implant and at follow-up
*Dual cathode
Options for CRT-D:
| Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
Clinically Proven 2
| Study Endpoint | Implant Success Rate | Dislodgement Complications* | Phrenic Nerve Complications | Mean LV Pacing Threshold (at 0.5 ms) |
|---|---|---|---|---|
| 1 month | 96.4% | 4.5% | 0% | 1.1 V ± 0.9 V (LV tip/RV coil) 1.9 V ± 2.0 V (LV ring/RV coil) |
* Complications are defined as adverse events that require invasive intervention
NASA Technology
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
- Unique SI Polyimide insulation material licensed by Medtronic from NASA
- High resistance to heat, moisture, and chemicals
NASA Technology Insulation
References
- Giannola G, Lacopino S, Lombardo E, et al. Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning. Europace. February 2011:244-250.
- Medtronic Attain Ability® Model 4196 Left Ventricular Lead, Final Clinical Report, Version 1, February 25, 2009, Medtronic, Inc.
Attain Ability Plus Left-Heart Lead –
4296 5.3 Fr, Dual Electrode
- The first 5.3 Fr dual electrode* left-heart lead that can be delivered with a sub-selection catheter (leads ≥ 88 cm length)
- Stable – designed to reach and maintain target vein position1
*Dual cathode
Attain Ability® 4296 Lead
Delivery Flexibility
The Attain Ability 4296 lead can be delivered with a guide wire or stylet. Compatible with:
- Attain Command® catheters, the first family of catheters to feature a hydrophilic coating
- Attain Select® II sub-selection catheters, enabling direct-to-vessel delivery for deep seating in difficult anatomies (in leads ≥ 88 cm length)
- Attain Hybrid® guide wire (GWR 4196), proven to reduce implantation time and improve access to target vein LV lead positioning1
Important Safety Information
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Key Features
- Dual electrode*
- Dual canted fixation for enhanced stability
- Steroid on both electrodes
- 5.3 Fr proximal lead diameter
- IS-1 connector
- Multiple pacing vectors help address phrenic nerve stimulation and prevent need for chronic electrode repositioning
- Ability to choose the best configuration for threshold optimization during implant and at follow-up
*Dual cathode
Options for CRT-D:
|
Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
Clinically Proven 2
| Study Endpoint |
Implant Success Rate |
Dislodgement Complications* |
Phrenic Nerve Complications |
Mean LV Pacing Threshold (at 0.5 ms) |
|---|---|---|---|---|
| 1 month | 92.9% | 1.3% | 0% | 0.9 V ± 0.6 V (LV tip/RV coil) 1.6 V ± 1.8 V (LV ring/RV coil) |
* Complications are defined as adverse events that require invasive intervention
NASA Technology
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
- Unique SI Polyimide insulation material licensed by Medtronic from NASA
- High resistance to heat, moisture, and chemicals
NASA Technology Insulation
References
- Giannola G, Lacopino S, Lombardo E, et al. Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning. Europace. February 2011:244-250.
- Medtronic Attain Ability® Plus 4296 Market Release Report, Version 1, January 20, 2010, Medtronic, Inc.
Attain Ability Straight Left-Heart Lead –
4396 4 Fr, Dual Electrode
- The first 4 Fr straight dual electrode left-heart lead facilitates maneuvering through small venous anatomies1
- The lead’s flexible tapered distal end, combined with the agility of the Attain Hybrid® guide wire, enhance trackability and control1
*Dual cathode
Attain Ability® 4396 Lead
Delivery Flexibility
The Attain Ability 4396 lead can be delivered with a guide wire or stylet. Compatible with:
- Attain Select® II sub-selection catheters, enabling direct-to-vessel delivery for deep seating in difficult anatomies (in leads ≥ 88 cm length)
- Attain Command® catheters, the first family of catheters to feature a hydrophilic coating
- Attain Hybrid® guide wire (GWR 4196), proven to reduce implantation time and improve access to target vein LV lead positioning1
Important Safety Information
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Key Features
- Dual electrode*
- Straight with tined fixation
- Steroid on both electrodes
- 4.0 Fr proximal lead diameter
- IS-1 connector
- Multiple pacing vectors help address phrenic nerve stimulation and prevent need for chronic electrode repositioning
- Ability to choose the best configuration for threshold optimization during implant and at follow-up
*Dual cathode
Attain Ability 4396 Pacing Vectors
Options for CRT-D:
| Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
Clinically Proven 2
96.8% of physicians positively rated the handling of the 4396 lead and the ability to maneuver it to the desired cardiac veins in their patients.
| Study Endpoint | Implant Success Rate | Dislodgement Complications* | Phrenic Nerve Complications | Mean LV Pacing Threshold (at 0.5 ms) |
|---|---|---|---|---|
| 1 month | 92.9% | 3.2% | 1.3% | 1.6 V ± 1.5 V at 1 mon (LV tip/RV coil) 2.7 V ± 2.4 V at 3 mons (LV ring/RV coil) |
* Complications are defined as adverse events that require invasive intervention
Attention: In the 4396 clinical study, 14 of 106 subjects (13.2%) had pacing capture thresholds (PCT) ≥ 3.0 V (measured at 0.5 ms at 3 months). PCT ≥ 3.0 V can be associated with phrenic nerve stimulation, battery depletion, and loss of capture. The Model 4396 lead provides a straight tip, tined fixation, and small diameter, which may be needed for some patients. See the technical manual for more information.
NASA Technology
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
- Unique SI Polyimide insulation material licensed by Medtronic from NASA
- High resistance to heat, moisture, and chemicals
Multiple Layers
NASA Technology Insulation
References
- Giannola G, Lacopino S, Lombardo E, et al. Efficacy of a tool combining guide-wire and stylet for the left ventricular lead positioning. Europace. February 2011:244-250.
- Attain Ability® Straight Model 4396 Left Ventricular Lead, Summary of Clinical Results, February 25, 2011 (M940625A001), Medtronic, Inc.
Attain Bipolar OTW Left-Heart Lead –
4194 6 Fr
Designed for medium to large veins with moderate tortuosity.
Attain 4194 Lead
Delivery Flexibility
The Attain Bipolar OTW 4194 lead can be delivered with a guide wire or stylet. Compatible with the:
- Attain Command® catheters, the first family of catheters to feature a hydrophilic coating
- Attain Hybrid® guide wire (GWR 4196), designed to potentially reduce the number of tools used at implant
Important Safety Information
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Key Features
- Flexible anode coil designed for easy trackability and pushability in varying venous anatomies
- Angled distal end designed for steerability and stable fixation
- Steroid eluting
- Tip seal allows acute guide wire re-insertion and minimizes blood ingress
- Available in 78 cm and 88 cm lengths
- Bipolar
- 6.0 Fr proximal lead diameter
- IS-1 Connector
Clinically Proven 1
| Study Endpoint | Implant Success Rate |
Dislodgement Complications* |
Phrenic Nerve Complications |
Mean LV Pacing Threshold (at 0.5 ms) |
|---|---|---|---|---|
| 3 months | 87.8% | 2.1% | 0.5% | 1.6 V ± 1.1 V |
*Complications are defined as adverse events that require invasive intervention.
Reference
- Medtronic Attain® Bipolar OTW Model 4194 Lead, Final Clinical Report, Version 1, January 31, 2005, Medtronic, Inc.
Attain StarFix Left-Heart Lead –
4195 5 Fr, Unipolar
Attain StarFix® LV lead is the first active fixation left-heart lead with a 0% chronic dislodgement rate (chronic defined as two days or longer post-implant).
- Active fixation left-heart lead with exclusive deployable lobes, allowing for customized lead placement in a wide range of vein sizes and locations
- The 0% chronic dislodgement rate is supported by one of the industry’s largest left-heart lead clinical studies involving 385 implants followed for up to four years1
Delivery Flexibility
The Attain StarFix lead can be delivered with a guide wire or stylet. Compatible with:
- Attain Command® catheters, the first family of catheters to feature a hydrophilic coating
- Attain Hybrid® guide wire (GWR 4195), designed to potentially reduce the number of tools used at implant
Important Safety Information
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Key Features
- Exclusive deployable lobes expand to 24 Fr, allowing customized lead placement in a wide range of vein sizes and locations
- 0% chronic dislodgement rate supported by left-heart lead studies involving 385 implants followed for up to four years1
- 5 Fr proximal lead body
- Unipolar
- Steroid eluting
- Polyurethane insulation
- IS-1 connector
Clinically Proven 1
| Study Endpoint | Implant Success Rate | Dislodgement Complications* | Phrenic Nerve Complications | Mean LV Pacing Threshold (at 0.5 ms) |
|---|---|---|---|---|
| 3 months | 94.4% | 0.7% | 2.7% | 1.3 V ± 0.8 V |
*Complications are defined as adverse events that require invasive intervention.
Reference
- Attain StarFix Model 4195 Left Ventricular Lead, FDA IDE Final Report, November 18, 2008, Medtronic, Inc.
