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Healthcare Professionals
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.
Detail – Attain Lead Family Vein Diameter Continuum
Attain® Family of LV Leads – Table 1 of 2 | |||
---|---|---|---|
4298 | 4398 | 4598 | |
Compatibility | IS-4 | IS-4 | IS-4 |
OTW Delivery | Yes | Yes | Yes |
Stylet Delivery | Yes | Yes | Yes |
Distal Lead Diameter | 3.9 Fr | 3.9 Fr | 3.9 Fr |
Proximal Lead Diameter | 5.3 Fr | 5.3 Fr | 5.3 Fr |
Tip Seal | Yes | Yes | Yes |
Distal Shape | Dual cant | Straight | Offset S curve |
Fixation | Passive | Tines | Passive |
Polarity | Quadripolar | Quadripolar | Quadripolar |
Distal ESA | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 |
Proximal ESA | 5.8 mm2 | 5.8 mm2 | 5.8 mm2 |
Electrode Separation | 21.0 mm LV1-LV2, 1.3 mm LV2-LV3, 21 mm LV3-LV4 | 21.0 mm LV1-LV2, 1.3 mm LV2-LV3, 21 mm LV3-LV4 | 21.0 mm LV1-LV2, 1.3 mm LV2-LV3, 21 mm LV3-LV4 |
Lead Lengths | 78, 88 cm | 78, 88 cm | 78, 88 cm |
Compatible with Select II + SureValve Sub-Selection Catheter | Yes | Yes | Yes |
Attain® Family of LV Leads – Table 2 of 2 | |||||
---|---|---|---|---|---|
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 + SureValve Sub-Selection Catheter | No | No | Yes | Yes | Yes |
Advanced Quadripolar Leads with More Shape Options – designed to address common clinical challenges
Short Bipolar Spacing – Reduce phrenic nerve stimulation occurrence1-3
Steroid on All Electrodes – Improve thresholds and longevity4
Compatible with all Attain™ Delivery Systems – Use preferred delivery tools including sub-selection catheters
Detail – Attain Performa Quad Lead Portfolio
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
Biffi M, et al. Utilizing Short Spacing between Quadripolar LV lead Electrodes to Avoid PNS. Cardiostim 2014, Poster presentation, Session 56P.
Biffi M, Foerster L, Eastman W, et al. Effect of bipolar electrode spacing on phrenic nerve stimulation and left ventricular pacing thresholds: an acute canine study. Circ Arrhythm Electrophysiol. August 1, 2012;5(4):815-820.
Biffi M, Zanon F, Bertaglia E, et al. Short-spaced dipole for managing phrenic nerve stimulation in patients with CRT: the “phrenic nerve mapping and stimulation EP” catheter study. Heart Rhythm. January 2013;10(1):39-45.
Lunati MG, Gasparini M, Landolina M, et al. Long-Term Effect of Steroid Elution on the Electrical Performance of Coronary Sinus Leads for Cardiac Resynchronization Therapy. Presented at HRS 2012 (AB10-05).
The first 4 Fr dual electrode* left-heart lead featuring a flexible, tapered distal end for navigating difficult anatomies. Compatible with Select™ II + SureValve™ sub-selection catheters.
Attain AbilityTM 4196 Lead
Detail Attain Ability 4196 Option
The Attain Ability 4196 lead can be delivered with a guide wire or stylet. Compatible with:
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
*Dual cathode
Attain Ability 4196 Pacing Vectors
Options for CRT-D:
|
Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
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 1.9 V ± 2.0 V |
Complications are defined as adverse events that require invasive intervention
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
NASA Technology Insulation
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.
*Dual cathode
Attain Ability® 4296 Lead
Attain Ability 4296 Option
The Attain Ability 4296 lead can be delivered with a guide wire or stylet. Compatible with:
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
*Dual cathode
Attain Ability 4296 Pacing Vectors
Options for CRT-D:
|
Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
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 1.6 V ± 1.8 V |
Complications are defined as adverse events that require invasive intervention
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
NASA Technology Insulation
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.
*Dual cathode
Attain Ability® 4396 Lead
Attain Ability 4396 Option
The Attain Ability 4396 lead can be delivered with a guide wire or stylet. Compatible with:
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
*Dual cathode
Options for CRT-D:
|
Options for CRT-P†:
† Medtronic Consulta® and Syncra™ CRT-P devices |
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 2.7 V ± 2.4 V at 3 mons |
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.
Insulation used in the Attain Ability family of leads was developed by NASA for use in harsh environments.
Multiple Layers
NASA Technology Insulation
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 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).
Detail Attain StarFix Leads
Attain StarFix Option
The Attain StarFix lead can be delivered with a guide wire or stylet. Compatible with:
Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.
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.
Attain StarFix Model 4195 Left Ventricular Lead, FDA IDE Final Report, November 18, 2008, Medtronic, Inc.
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.
IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS
For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .