FLAGSHIP Early Feasibility Trial

Investigational device, limited by Federal (or United States) law to investigational use.

The aorta, your largest artery, is the main pathway which carries blood from your heart to the rest of your body. Various disorders and conditions that affect the aorta are classified as aortic diseases.

Aortic dissection is a serious condition in which there is a separation between the inner and middle layers of the aorta. When blood flows through that separation (dissection), a new flow channel is created, also referred to as a “false lumen”. This can be a life-threatening situation.

Aortic dissections can be treated through open surgical repair, or through an endovascular (less invasive), life-saving procedure called TEVAR (Thoracic Endovascular Aortic Repair).

However, TEVAR alone for aortic dissection does not always address the abnormal false lumen flow. This unmet clinical need is significant and can be associated with higher risks of complications, rehospitalization, increased costs, and increased mortality.

Shape Memory Medical is dedicated to patients and physicians by developing new aortic restorative therapies using our novel smart polymer technology through various clinical studies.

FLAGSHIP First in Human Study

FLAGSHIP FIH is the first prospective clinical trial to evaluate the Smart False Lumen Device in Aortic Dissection patients and its potential to remodel the flow and occlude the tear using various approaches. The study will enroll up to 30 patients across two centers in New Zealand.

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer – First-in-Human Study.

FLAGSHIP is a prospective multicenter, safety and early feasibility trial to determine the safety and efficacy of the False Lumen Device to prevent aortic growth.

FLAGSHIP - Read More

Information for Patients