Amplia MRI Quad CRT-D Leads & Delivery

ATTAIN PORTFOLIO

Attain Portfolio

Vein Diameter Continuum

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

Reference

¹

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.

PERFORMA QUAD 4298/4398/4598

Attain® Performa™ Left-Heart Leads Model 4298/4398/4598 5.3 Fr, Quadripolar

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

Advanced Quadripolar Leads with More Shape Options – designed to address common clinical challenges

Short Bipolar Spacing – Reduce phrenic nerve stimulation occurrence^1-3
Steroid on All Electrodes – Improve thresholds and longevity⁴
Compatible with all Attain^® Delivery Systems – Use preferred delivery tools including sub-selection catheter

Detail – Attain Performa Quad Lead Portfolio

Attain Performa with Short Bipolar Spacing vs Other Quadripolar LV Lead with Wide Electrode Spacing

Important Safety Information

Surgical complications, such as cardiac perforation, may occur and care must be taken when placing and positioning a cardiac lead.

Specifications

Attain Performa MRI SureScan Model 4298

Attain Performa Straight MRI SureScan Model 4398

Attain Performa S MRI SureScan Model 4598

Reference

¹

Biffi M, et al. Utilizing Short Spacing between Quadripolar LV lead Electrodes to Avoid PNS. Cardiostim 2014, Poster presentation, Session 56P.

²

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.

³

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.

⁴

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).

ABILITY 4196

Attain Ability Left-Heart Lead – 4196 4 Fr, Dual Electrode

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

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-4196-Features

Attain Ability^® 4196 Lead

Attain-4196-Venogram

Detail Attain Ability 4196 Option

Delivery Flexibility

The Attain Ability 4196 lead can be delivered with a guide wire or stylet. Compatible with:

Attain Command^® + SureValve™ catheters, the first family of catheters to feature a hydrophilic coating
Attain Select™ II + SureValve™ 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

Attain-4196-Vectors

Attain Ability 4196 Pacing Vectors

Options for CRT-D:

Options for CRT-P^†:

LV tip to RV coil
LV ring to RV coil
LV tip to ring (LV bipolar)

LV ring to can
LV tip to can
LV tip to RV ring
LV ring to RV ring
LV tip to LV ring

^† Medtronic Consulta^® and Syncra™ CRT-P devices

Clinically Proven²

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

Specifications

Attain Ability MRI SureScan Model 4196 Spec Sheet

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

¹

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.

²

Medtronic Attain Ability^® Plus 4296 Market Release Report, Version 1, January 20, 2010, Medtronic, Inc.

ABILITY 4296

Attain Ability Plus Left-Heart Lead –
4296 5.3 Fr, Dual Electrode

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

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-4296-Features

Attain Ability® 4296 Lead

Attain-4296-Venogramlg

Delivery Flexibility

The Attain Ability 4296 lead can be delivered with a guide wire or stylet. Compatible with:

Attain Command® + SureValve™ catheters, the first family of catheters to feature a hydrophilic coating
Attain Select™ II + SureValve™ 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

Attain-4296-Vectors

Attain Ability 4296 Pacing Vectors

Options for CRT-D:

Options for CRT-P^†:

LV tip to RV coil
LV ring to RV coil
LV tip to ring (LV bipolar)

LV ring to can
LV tip to can
LV tip to RV ring
LV ring to RV ring
LV tip to LV ring

^† Medtronic Consulta^® and Syncra™ CRT-P devices

Clinically Proven²

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

Specifications

Attain Ability MRI SureScan Model 4296 Spec Sheet

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

¹

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.

²

Medtronic Attain Ability^® Plus 4296 Market Release Report, Version 1, January 20, 2010, Medtronic, Inc.

ABILITY 4396

Attain Ability Straight Left-Heart Lead – 4396 4 Fr, Dual Electrode

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

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-4396-Features

Attain Ability^® 4396 Lead

Attain-4396-Venogramlg

Attain Ability 4396 Option

Delivery Flexibility

The Attain Ability 4396 lead can be delivered with a guide wire or stylet. Compatible with:

Attain Command^® + SureValve™ catheters, the first family of catheters to feature a hydrophilic coating
Attain Select™ II + SureValve™ 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*
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^†:
LV tip to RV coil LV ring to RV coil LV tip to ring (LV bipolar)	LV tip to can LV tip to RV ring LV tip to LV ring LV ring to can LV ring to RV ring ^† Medtronic Consulta^® and Syncra™ CRT-P devices

Clinically Proven²

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.

Specifications

Attain Ability Straight MRI SureScan Model 4396 Spec Sheet

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

¹

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.

²

Attain Ability^® Straight Model 4396 Left Ventricular Lead, Summary of Clinical Results, February 25, 2011 (M940625A001), Medtronic, Inc.

STARFIX 4195

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

Attain-4195-Features

Detail Attain StarFix Leads

Attain-4195-Venogramlg

Attain StarFix Option

Delivery Flexibility

The Attain StarFix lead can be delivered with a guide wire or stylet. Compatible with:

Attain Command^® + SureValve^™ 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 Proven¹

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

¹

Attain StarFix Model 4195 Left Ventricular Lead, FDA IDE Final Report, November 18, 2008, Medtronic, Inc.

Amplia MRI Quad CRT-D

Left Heart Leads

Attain Portfolio

Attain® Family of LV Leads – Table 1 of 2

Attain® Family of LV Leads – Table 2 of 2

Reference

Attain® Performa™ Left-Heart Leads Model 4298/4398/4598 5.3 Fr, Quadripolar

TESTED AND DEMONSTRATED SAFE IN THE MRI AS PART OF A SURESCAN CRT-D SYSTEM

Important Safety Information

Specifications

Reference

Attain Ability Left-Heart Lead – 4196 4 Fr, Dual Electrode

TESTED AND DEMONSTRATED SAFE IN THE MRI AS PART OF A SURESCAN CRT-D SYSTEM

Delivery Flexibility

Important Safety Information

Key Features

Clinically Proven2

Specifications

NASA Technology

References

Attain Ability Plus Left-Heart Lead – 4296 5.3 Fr, Dual Electrode

Delivery Flexibility

Important Safety Information

Key Features

Clinically Proven2

* Complications are defined as adverse events that require invasive intervention

Specifications

NASA Technology

References

Attain Ability Straight Left-Heart Lead – 4396 4 Fr, Dual Electrode

TESTED AND DEMONSTRATED SAFE IN THE MRI AS PART OF A SURESCAN CRT-D SYSTEM

Delivery Flexibility

Important Safety Information

Key Features

Attain Ability 4396 Pacing Vectors

Clinically Proven2

Specifications

NASA Technology

References

Attain StarFix Left-Heart Lead – 4195 5 Fr, Unipolar

Delivery Flexibility

Important Safety Information

Clinically Proven1

Reference

Attain^® Family of LV Leads – Table 1 of 2

Attain^® Family of LV Leads – Table 2 of 2

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

Clinically Proven²

Attain Ability Plus Left-Heart Lead –
4296 5.3 Fr, Dual Electrode

Clinically Proven²

TESTED AND DEMONSTRATED SAFE IN THE MRI
AS PART OF A SURESCAN CRT-D SYSTEM

Clinically Proven²

Clinically Proven¹