Medtronic has commenced the real-world and post-market study to assess the safety and effectiveness of the Valiant Navion thoracic stent graft system to treat thoracic aortic dissection.
The prospective, observational, global and multi-centre DISSECT-N trial will recruit up to 200 patients with an acute or chronic thoracic aortic dissection at around 45 sites in North America, Europe, and Asia Pacific.
The first patient procedure in the trial was carried out at Northwell Health in New York by aortic surgery director Dr Derek Brinster.
The patients in the trial will be followed for three years
Medtronic has decided to follow patients for three years. Dr Milner and Dr Robin Heijmen are the primary investigators of the trial.
DISSECT-N study European principal investigator Dr Heijmen said: “Thoracic aortic dissection is dangerous, with some cases leading to severe internal bleeding or irreversible organ damage; with the Valiant Navion system, more patients with aortic dissection are eligible for thoracic endovascular aneurysm repair (TEVAR).”
Medtronic’s study’s primary endpoint is composite safety and effectiveness, comprising technical procedure success and freedom from major adverse events (MAEs) reported up to one month following the index procedure.
The low-profile Valiant Navion system secured approval from the US Food and Drug Administration in October 2018, while the CE mark approval in November same year, and the approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan in September 2019.
An aortic dissection is a condition in which the inner layer of the lower aorta is torn, resulting in the separation of the inner and middle layers of the aorta.
Medtronic cardiac and vascular group’s aortic business general manager and vice president John Farquhar said: “There remains a significant clinical unmet need in treating thoracic dissection, and we are dedicated to improving the care for these patients through an endovascular approach.
“With the DISSECT-N study, we hope to further support the Valiant Navion system as a less invasive approach to treating this condition.”
In June, Medtronic secured FDA approval for its Percept PC deep brain stimulation (DBS) system.
