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11 December, 2020

New Zealand First Endovascular technology to treat patients with thoracic aortic disease

Global “dissect-n” post-market study to broaden evidence base for safety and effectiveness of commercially available valiant™ navion endovascular repair technology

Valiant™ Navion Endovascular Repair Technology

Medtronic Australasia today announced the first New Zealand patient was enrolled in the Medtronic DISSECT-N study, which will assess the real-world safety and effectiveness of the Valiant Navion™ thoracic stent graft system in the treatment of thoracic aortic dissection. A 78-year-old woman from Auckland living with thoracic aortic disease is the first patient in the Asia Pacific region to be enrolled in the global clinical study evaluating the Valiant Navion system, avoiding the need for major cardiothoracic surgery. The first procedure in New Zealand was performed by Dr. Andrew Holden and the team at Auckland City Hospital in Auckland, New Zealand.

A thoracic aortic dissection is a condition in which a tear develops in the inner layer of the aorta, the main blood-carrying vessel in the chest. Blood flows through this tear into the middle layer of the wall of the aorta causing the inner and middle layers to separate (dissect).1 If the tear goes through the vessel wall (rupture), dissection can be life threatening due to the potential for bleeding inside the body. Even without a rupture, dissection may cause a problem of aortic dissection where the vessel supplying blood to the organs in the body narrows down or is completely blocked resulting in organ failure.1 About two-thirds of people who have an aortic dissection are male, and those with high blood pressure, high cholesterol or atherosclerosis, inflamed arteries, and smoking may be at greater risk.2

The Valiant Navion Thoracic Stent Graft system is indicated for the endovascular repair of all lesions in the descending thoracic aorta, including dissection. Additional real-world evidence generated for the dissection indication would further strengthen existing supporting evidence.

The DISSECT-N study is a large prospective thoracic aortic dissection repair study which represents the first study of the Valiant Navion system to focus solely on the dissection patient population. The study also includes independent core-lab imaging review, which will offer critical contemporary insights about TEVAR use in patients with various types of the thoracic aortic dissection. The clinical study will enroll at least 200 patients with an acute or chronic thoracic aortic dissection across approximately 45 sites in North America, Europe, and Asia Pacific. The primary endpoint is composite safety and effectiveness, including technical procedure success and freedom from major adverse events (MAEs) reported up to one month following the index procedure. Patients will be followed for three years.

The Valiant Navion Thoracic Stent Graft System is commercially available in both Australia and New Zealand.

About the Valiant Navion Thoracic Stent Graft System

The Valiant Navion Thoracic Stent Graft System is a minimally invasive implantable stent graft (a fabric tube supported by a metal framework) intended to repair lesions in the thoracic aorta (large artery in the chest) through a small cut in the groin without the need for a big cut in the chest. A minimally invasive technology, the low-profile delivery system is carefully guided within the artery to treat the diseased or injured section of the aorta. Valiant Navion also features both FreeFlo (proximal bare metal) and CoveredSeal (proximal covered) configurations which enable physicians to treat varying patient anatomies and pathologies. Specifically, Valiant Navion CoveredSeal is tailored to treat patients with fragile aortic walls, commonly seen in aortic dissection. After being placed in the artery, the stent graft self-expands and aims to relieve the pressure on this section of the aorta by providing a new pathway for blood flow.3

About Medtronic

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in approximately 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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.


https://www.mayoclinic.org/diseases-conditions/aortic-dissection/symptoms-causes/syc-20369496

2 “Your Aorta: The Pulse of Life.” American Heart Associationhttps://www.heart.org/en/health-topics/aortic-aneurysm/your-aorta-the-pulse-of-life. Accessed 19 November 2020.

3 BJA: British Journal of Anaesthesia, Volume 117, Issue suppl_2, September 2016, Pages ii3–ii12, https://doi.org/10.1093/bja/aew222