Medtronic, the global leader in healthcare technology, today announced it has entered into an exclusive U.S. distribution agreement with Raleigh, North Carolina-based Contego Medical. Under the agreement, Medtronic will be the sole U.S. distributor for Contego’s portfolio of commercially available products, which provide revascularization treatment for carotid and peripheral vascular disease. The agreement also includes an increased investment in Contego and an option to acquire the company. Medtronic has held a minority investment in Contego since 2020.

“Contego’s innovations, backed by excellent data^1-6, are transforming how carotid disease is treated and complement the Medtronic peripheral and stroke protection portfolio," said David Moeller, senior vice president and president of Medtronic Peripheral Vascular Health, which is part of the company’s Cardiovascular portfolio. "This strategic agreement with Contego Medical expands our commitment to this fast-growing carotid market and exemplifies Medtronic’s steadfast dedication to advancing innovation and enhancing patient care.”

This agreement includes Contego Medical’s portfolio of commercially available products, including the recently FDA approved Neuroguard IEP® System, a unique 3-in-1 carotid stenting system that combines a high-performance⁷ stent, post-dilation balloon, and an integrated embolic protection (IEP) filter as well as Excipio® Peripheral Thrombectomy Devices.    

The Neuroguard IEP system is backed by clinical data demonstrating the safety and effectiveness of the system. Contego reports the PERFORMANCE I Trial and PERFORMANCE II IDE Trial consistently recorded unprecedented low event rates – zero major strokes, zero neurologic deaths, and zero stent thromboses up to 2-year follow-up.^1-6  Additionally, Contego Medical is currently evaluating the Neuroguard IEP System with a next-generation direct transcarotid access and protection system, TCAR-IEP, to demonstrate advanced stroke protection regardless of vascular approach 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.

“This strategic agreement marks a significant milestone for both Contego Medical and Medtronic. By combining our innovative product portfolio with Medtronic’s extensive market presence and clinical leadership, we are positioned to revolutionize revascularization treatment in the carotid and peripheral vascular disease space,” said Ravish Sachar, MD, founder and chief executive officer of Contego Medical. “This partnership enhances our ability to deliver state-of-the-art solutions to patients and reinforces our commitment to expanding access across the United States.”

Medtronic intends to leverage its Peripheral Vascular and Neurovascular commercial teams to distribute Contego’s portfolio of products in spring 2025.

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 Medtronic 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 U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:

Laura Hennen                                   Ryan Weispfenning
Public Relations                               Investor Relations
+1-763-213-3034                             +1-763-505-4626

References

1. PERFORMANCE II: Gray W, MD. Two-Year Outcomes of the PERFORMANCE II Trial: A Prospective, Multicenter, Single-Arm Investigation of a 3-in-1 Carotid Stent System With Integrated Embolic Protection. Presented at: VIVA; November 4 2024; Las Vegas, NV
2. PERFORMANCE I: 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 Nov;100(6):1090-1099.  
3. EVA-3S: Mas JL, Chatellier G, Beyssen B, et al; EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-1671.  
4. CREST: Brott TG, Hobson RW 2nd, Howard G, et al.; CREST Investigators. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med. 2010 Jul 1;363(1):11-23. Erratum in: N Engl J Med. 2010 Jul 29;363(5):498. Erratum in: N Engl J Med. 2010 Jul 8;363(2):198.  
5. SAPPHIRE: Yadav JS, Wholey MH, Kuntz RE, et al; Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004 Oct 7;351(15):1493-1501.  
6. ACT I: Rosenfield K, Matsumura JS, Chaturvedi S, et al; ACT I Investigators. Randomized trial of stent versus surgery for asymptomatic carotid stenosis. N Engl J Med. 2016 Mar 17;374(11):1011-1020
7. Bench test data on file. Contego Medical, Inc.