Carotid

Neuroguard IEP™* system

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Carotid

Neuroguard IEP™* system

The Neuroguard IEP™* System is a 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection (IEP).

Ordering information
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Indications, Safety, and Warnings

Description

The Neuroguard IEP™* System is approved for use in carotid stenting procedures.

The Neuroguard IEP™* System is a unique 3-in-1 stenting system highlighted by a 40-micron IEP filter to catch the micro-emboli other protection mechanisms can’t.†,1,2

Features

Integrated 3-in-1 technology3

This is an image of the Neuroguard IEP™* System stent, shown with a bent curve to demonstrate flexibility.

Purpose-built stent3

  • FlexRing™* technology — provides the benefits of both open- and closed-cell stents with flexibility and radial strength‡,4,5
  • Maximum coverage — closed-cell asymmetrical hourglass designed for maximum plaque coverage and minimal outward pressure at lesion‡,4
  • Designed for precision — built for precise and predictable deployment‡,4,5
  • Exceptional strength — verified radial resistive strength, which may minimize the risk of deformation due to calcium‡,5
  • Consistent conformity — demonstrated flexibility and conformability to the vessel wall, even in tortuous anatomy, with kink resistance up to > 270 degrees‡,4
  • Built to fit — short landing zone means the system could be used on more than 94% of patient anatomies§,3,6,7
This is a close-up image of the Neuroguard IEP™* System 40-micron filter, preventing particles from passing through.

40-micron IEP filter

  • Captures more micro-embolic debris: proprietary 40-micron filter pores are approximately three times smaller than traditional filters†,1,2,8,9
  • Physician-controlled filter can be adjusted to the anatomy to help prevent particles from passing around the filter‡,3
This is a close-up image of the Neuroguard IEP™* post-dilation balloon.

Integrated post-dilation balloon

  • Reduces catheter exchanges and improves procedural efficiency‡,◊,3
  • Facilitates crossing the lesion with fewer passes‡,◊,3

See how it works.

Clinical evidence

Let’s get to zero.

The Neuroguard IEP™* System demonstrated exceptional outcomes at 30 days and 1 year in the PERFORMANCE II Study.6

0

major strokes6

0

stent thromboses6

0

neurological deaths6

1.3% 30-day all stroke and 1.8% 30-day all stroke plus 12-month ipsilateral stroke, 2.8% primary endpoint through 12 months¶,6

Low rates of stroke with IEP6,8,10–14

Two clinical studies of the Neuroguard IEP™* System demonstrated 99% freedom from any stroke through 30 days# and the lowest one–year stroke outcomes for CAS pivotal trials.6,10,11,15–18


Minor and major stroke rates in carotid stenting through 30 days

View this bar chart to see the minor and major stroke rates in carotid stenting through 30 days.

CAS, carotid artery stenting; CEA, carotid endarterectomy; IEP, integrated embolic protection;
TCAR, trans-carotid artery revascularization

Results are not directly comparable. Stroke rates may be defined differently. In some cases, the sum of minor and major stroke rates will exceed the total stroke rate. Information provided is for illustration purposes only and may differ in head-to-head comparison.

Risks may include hypertension/hypotension, angina, cerebral ischemia, transient ischemic attack, headache, and bradycardia.

Ordering information


Peripheral vascular

  Stent (mm) Balloon (mm) IEP filter (mm) System
Item number Product description Unconstrained stent diameter
Proximal end/mid-stent/distal end		 Reference vessel diameter
CCA/ICA/ICA distal		 Length OD  Length Length Diameter Minimum sheath/guide ID Available catheter length (cm)
NG-0630-140-2 Neuroguard IEP™* 140 cm, 8/6/7 x 30 PV 8/6/7​ 6-7/4-5/5-6 30 5 24 18 Adjustable up to 7 0.084"
(2.1 mm)		 140
NG-0640-140-2 Neuroguard IEP™* 140 cm, 8/6/7 x 40 PV​ 8/6/7​ 6-7/4-5/5-6​ 40 5 34 18 Adjustable up to 7 0.084"
(2.1 mm)		 140
NG-0730-140-2 Neuroguard IEP™* 140 cm, 9/7/8 x 30 PV 9/7/8​ 7-8/5-6/6-7​ 30 5 24 18 Adjustable up to 7 0.084"
(2.1 mm)		 140
NG-0740-140-2 Neuroguard IEP™* 140 cm, 9/7/8 x 40 PV 9/7/8​ 7-8/5-6/6-7 40 5 34 18 Adjustable up to 7 0.084"
(2.1 mm)		 140


Neurovascular

  Stent (mm) Balloon (mm) IEP filter (mm) System
Item number Product description Unconstrained stent diameter
Proximal end/mid-stent/distal end		 Reference vessel diameter
CCA/ICA/ICA distal		 Length OD  Length Length Diameter Crossing profile Minimum sheath/guide ID Available catheter length (cm)
NG-NV-6-30 Neuroguard IEP™* 140 cm, 8/6/7 x 30 NV 8/6/7​ 6-7/4-5/5-6 30 5 24 18 Adjustable up to 7 0.080"
(2.0 mm)		 0.084"
(2.1 mm)		 140
NG-NV-6-40 Neuroguard IEP™* 140 cm, 8/6/7 x 40 NV 8/6/7​ 6-7/4-5/5-6​ 40 5 34 18 Adjustable up to 7 0.080"
(2.0 mm)		 0.084"
(2.1 mm)		 140
NG-NV-7-30 Neuroguard IEP™* 140 cm, 9/7/8 x 30 NV 9/7/8 7-8/5-6/6-7​ 30 5 24 18 Adjustable up to 7 0.080"
(2.0 mm)		 0.084"
(2.1 mm)		 140
NG-NV-7-40 Neuroguard IEP™* 140 cm, 9/7/8 x 40 NV 9/7/8​ 7-8/5-6/6-7 40 5 34 18 Adjustable up to 7 0.080"
(2.0 mm)		 0.084"
(2.1 mm)		 140



Medtronic is the sole authorized distributor of commercially available Contego Medical products in the United States. Medtronic, Medtronic logo, and Engineering the extraordinary are trademarks of Medtronic. TM* third party brands are trademarks of their respective owner. All other brands are trademarks of a Medtronic company. Please refer to product labeling for indications, contraindications, warnings, and instructions for use. Contact your local Medtronic representative for availability or more information.

TM* Third-party brands are trademarks of their respective owners.

† Pore sizes of various embolic protection devices: Neuroguard IEP™* 40 μm, ANGIOGUARD™* RX 100 μm, Emboshield NAV6™* 120 μm.

‡ Bench test data many not be indicative of clinical performance.

§ Based on PERFORMANCE II screening due to short landing zone or tortuosity.

◊ The integrated stent with post-dilation balloon eliminates the catheter exchanges associated with using two separate devices.

Primary endpoint (composite of 30-day death/MI/stroke and 1-year ipsilateral stroke rates).

# Weighted average of 30-day stroke rate in PERFORMANCE II (1.3%, 4/305), PERFORMANCE I (0%, 0/67).

Δ SAPPHIRE rate of all stroke = 3.6% (6/167)​.

∞ ACT 1 rate of all stroke = 2.8% (30/1072).

  1. Based on pore sizes of various embolic protection devices: ANGIOGUARD™* RX 100 μm, Emboshield NAV6™* 120 μm. Per labeling of devices.
  2. Based on internal test report TR-1116-01, capture efficiency testing, Paladin®* vs. competitive products. Contego Medical, Inc. data on file.

  1. Based on internal test report DIDO-0001 rev 04, Neuroguard IEP™* System design input and design output. Contego Medical, Inc. data on file.
  2. Based on internal test report TR-1413-09, Neuroguard design verification. Contego Medical, Inc. data on file.
  3. Based on internal test report Contego Neuroguard PMA, section 7, design verification DV TR-2022. Data on file.
  4. Gray WA, Metzger DC, Zidar J, et al. The PERFORMANCE II trial: A prospective multicenter investigation of a novel carotid stent system. JACC Cardiovasc Interv. 2025;18(3):368–376. doi:10.1016/j.jcin.2024.10.031.
  5. Based on internal test report PERFORMANCE II screening. Contego Medical, Inc. data on file.
  6. Langhoff R, Schofer J, Scheinert D, et al. Double filtration during carotid artery stenting using a novel post-dilation balloon with integrated embolic protection. JACC Cardiovasc Interv. 2019;12(4):395–403. doi:10.1016/j.jcin.2018.11.039. Data on file.
  7. Siewiorek GM, Wholey MH, Finol EA. A comparative analysis of bench-top performance assessment of distal protection filters in transient flow conditions. J Endovasc Ther. 2012;19(2):249–260. doi:10.1583/11-3720.1.
  8. Langhoff R, Petrov I, Kedev S, et al. PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device. Catheter Cardiovasc Interv. 2022;100(6):1090–1099. doi:10.1002/ccd.30410.
  9. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351(15):1493–1501. doi:10.1056/NEJMoa040127.
  10. Brott TG, Hobson RW 2nd, Howard G, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010;363(1):11–23. Erratum in: N Engl J Med. 2010;363(5):498. Erratum in: N Engl J Med. 2010;363(2):198. doi:10.1056/NEJMoa0912321.
  11. Rosenfield K, Matsumura JS, Chaturvedi S, et al. Randomized trial of stent versus surgery for asymptomatic carotid stenosis. N Engl J Med. 2016;374(11):1011–1020. doi:10.1056/NEJMoa1515706.
  12. Kwolek CJ, Jaff MR, Leal JI, et al. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015;62(5):1227–1234. doi:10.1016/j.jvs.2015.04.460.
  13. EL2143734 2024-08-16. Abbott XACT™* transcarotid stent system instructions for use. Abbott; 2025.
  14. Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg. 2006;44(2):258–268. Erratum in: J Vasc Surg. 2007;45(1):226. doi:10.1016/j.jvs.2006.03.044.
  15. Iyer SS, White CJ, Hopkins LN, et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol. 2008;51(4):427–434. doi:10.1016/j.jacc.2007.09.045.
  16. Safian RD, Bresnahan JF, Jaff MR, et al. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol. 2006;47(12):2384–2389. doi:10.1016/j.jacc.2005.12.076. Protégé™ RX carotid stent system Instructions for Use: 500766-001c. Accessed April 2025. medtronic.com/content/dam/emanuals/cardio/500766-001_C_view.pdf.