Medtronic launches full distribution of the Neuroguard IEP™ System, establishing a new era in treating patients with carotid artery disease

Backed by exceptional clinical outcomes, the Neuroguard IEP™ System's unique 3-in-1 design provides enhanced embolic protection when it matters most. ^{1-5, †}

Medtronic, a global leader in healthcare technology, today announced the full distribution of the Neuroguard IEP™ System (Neuroguard) after a successful limited market distribution. This milestone follows the announcement earlier this year of its exclusive U.S. distribution agreement with Raleigh, North Carolina-based Contego Medical.

Neuroguard is the first carotid artery stent to offer a unique 3-in-1 technology that combines a high-performance stent⁶, an integrated dilation balloon, and integrated filter. Purposefully-built for the carotid artery,⁶ the closed-cell stent design with FlexRing™ technology provides the benefits of both open and closed cell stents with flexibility and radial strength.^{7-8, ‡} This integrated system offers physicians a faster, more streamlined, and efficient procedure. ^{6, 9-10 §◊¶}

"With this launch, we are setting a new standard of care for carotid artery disease," said David Moeller, SVP and president, Peripheral Vascular Health, which is part of the Cardiovascular Portfolio at Medtronic. "Our expanding participation in the growing carotid market underscores our commitment to providing physicians innovative solutions that address unmet health needs."

Carotid artery disease is a significant cause of stroke, causing approximately 15% of the 800,000 strokes in the U.S. each year.^11-12 Yet, paradoxically, the biggest risk in carotid artery stenting has been the risk of stroke, primarily from micro-embolic debris released during balloon dilation.¹⁴

"The unique 3-in-1 Neuroguard IEP System was designed to respond to this challenge with a 40-micron integrated embolic protection (IEP) filter, which has a smaller pore size to catch the micro-emboli that other protection mechanisms cannot,"^15-18# said Ravish Sachar, MD, founder and CEO, Contego Medical. "Partnering with the Medtronic commercial team is expanding our ability to bring this innovation to customers and usher in a new era of safer, smarter carotid artery stenting."

Neuroguard is supported by exceptional clinical data demonstrating the safety and effectiveness of the system. The PERFORMANCE II study (2022) demonstrated zero major strokes, zero neurological deaths, zero stent thromboses, and zero clinically driven target lesion revascularization despite 34.5% severely calcified lesions at 30 days and one year.^{19 ∆∞}

Additionally, Contego Medical is currently evaluating the Neuroguard IEP System with a next-generation direct transcarotid access and protection system, TCAR-IEP, to demonstrate safety and effectiveness in the PERFORMANCE III trial. The Neuroguard IEP Direct system is currently limited by Federal law to investigational use only and is not commercially available in the U.S.

Medtronic first announced the exclusive U.S. distribution agreement with Contego Medical in January 2025. Under the agreement, Medtronic is the sole U.S. distributor for Contego's portfolio of commercially available products through its Peripheral Vascular and Neurovascular commercial teams.

Neuroguard IEP™ and FlexRing™ are third party trademarks of Contego Medical.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

About Contego Medical, Inc.
Contego Medical, Inc. is the leader in developing state-of-the-art solutions that transform complex cases into simplified procedures. The company's portfolio of integrated, multi-functional products is designed to improve patient outcomes and procedural efficiency in the treatment of carotid and peripheral vascular disease. More than 3,000 patients have been treated with Contego Medical products to date.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Krystin Hayward
Public Relations
+1-508-298-8246

Ryan Weispfenning
Investor Relations
+1-763-505-4626

References

† Second filter provides extra embolic protection during post-dilitation

^‡ Bench test data may not be indicative of clinical performance

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

◊

Bench test data may not be indicative of clinical performance

¶ Median procedure times included Neuroguard IEP (n=305): 47 minutes, Traditional CAS (n=14,595): 61 minutes, Surgical CEA (n=82,737): 110 minutes
# Pore sizes of various embolic protection devices: Neuroguard™* 40μm, ANGIOGUARD™* RX 100μm, Emboshield NAV6™* 120μm.
∆ Clinically-driven target lesion revascularization as defined by >80% narrowing at the original treatment site by the angiographic core lab.

∞ 1.3% 30-day all stroke, 1.8% 30-day all stroke plus 12-month ipsilateral stroke, 2.8% primary endpoint (composite of 30-day death/MI/stroke and 1-year ipsilateral stroke rates) through 12 months

1. Vitek JJ, Roubin GS, Al-Mubarek N, New G, Iyer SS. Carotid artery stenting: Technical considerations. AJNR Am J Neuroradiol. 2000 Oct;21(9):1736-1743.
2. Martin JB, Pache JC, Treggiari-Venzi M, et al. Role of the distal balloon protection technique in the prevention of cerebral embolic events during carotid stent placement. Stroke. 2001 Feb;32(2):479-484.
3. Antonius Carotid Endarterectomy, Angioplasty, and Stenting Study Group. Transcranial Doppler monitoring in angioplasty and stenting of the carotid bifurcation. J Endovasc Ther. 2003 Aug;10(4):702-710.
4. Ackerstaff RG, Suttorp MJ, van den Berg JC, et al. Prediction of early cerebral outcome by transcranial Doppler monitoring in carotid bifurcation angioplasty and stenting. J Vasc Surg. 2005;41(4):618-624.
5. Hellings WE, Ackerstaff RG, Pasterkamp G, De Vries JP, Moll FL. The carotid atherosclerotic plaque and microembolisation during carotid stenting. J Cardiovasc Surg (Torino). 2006 Apr;47(2):115-126.
6. Contego Medical, Inc. Data on file; DIDO-0001 rev 04 Neuroguard IEP System Design Input and Design Output
7. Contego Medical, Inc. Data on file; TR-1413-09 Neuroguard Design Verification
8. Contego Medical, Inc. Data on file; Neuroguard PMA, Section 7_Design Verification DV TR-2022
9. Contego Medical, Inc. Data on file; CSR-1545 PERFORMANCE II 12-Month Primary Endpoint 27Mar2024
10. Columbo JA, Martinez-Camblor P, Stone DH, Goodney PP, O'Malley AJ. Procedural safety comparison between transcarotid artery revascularization, carotid endarterectomy, and carotid stenting: Perioperative and 1-year rates of stroke or death. J Am Heart Assoc. 2022 Oct
11. U.S. Centers for Disease Control and Prevention. Stroke Facts. Accessed Dec. 17, 2024. https://www.cdc.gov/stroke/data-research/facts-stats/index.html
12. Matthew L. Flaherty, Brett Kissela, Jane C. Khoury, Kathleen Alwell, Charles J. Moomaw, Daniel Woo, Pooja Khatri, Simona Ferioli, Opeolu Adeoye, Joseph P. Broderick, Dawn Kleindorfer; Carotid Artery Stenosis as a Cause of Stroke. Neuroepidemiology 1 December 2012; 40 (1): 36-41. https://doi.org/10.1159/000341410
13. Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge M-P, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang N-Y, Wong ND, Wong SS, Yaffe K, Palaniappan LP; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. Published online January 24, 2024. doi: 10.1161/CIR.0000000000001209
14. Ackerstaff RG, Suttorp MJ, van den Berg JC, et al; Antonius Carotid Endarterectomy, Angioplasty, and Stenting Study Group. Prediction of early cerebral outcome by transcranial Doppler monitoring in carotid bifurcation angioplasty and stenting. J Vasc Surg. 2005 Apr;41(4):618-624.
15. Per Iabeling of devices: Pore sizes of various embolic protection devices: ANGIOGUARD™* RX 100μm, Emboshield NAV6™* 120μm.
16. 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;12:395-403.
17. Contego. Data on file. TR-1116-01 Capture Efficiency Testing, Paladin vs Competitive Products
18. Siewiorek GM, et al. A comparative analysis of bench-top performance assessment of distal protection filters in transient flow conditions. J Endovasc Ther. 2012;19(2):249-260.
19. 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. 2024 Dec 20:S1936-8798(24)01467-5.