FDA Approves Aortic Dissection Hybrid Device

The aorta, which has three layers, carries oxygen-imbued blood through its innermost layer. Using arteries that branch from the aorta, the blood flows upward, through the chest all the way to the brain, and it flows downward, along the spine; the aorta itself ends near the pelvis. The point at which the ascending aorta is connected to the descending aorta is called the aortic arch.^1,2

People can die if a tear develops in that inner lining, as it diverts the blood flow from its critical mission. It is particularly deadly if the tear is close to the heart in the ascending aorta; such an event is termed a Type A dissection.^1,2

If there is a complete rupture of the three layers, some 40% of patients die immediately.^1,2

A Scottish-based research group has developed a stent-graft combination for Type A dissection. Called the Thoraflex Hybrid, the system allows for the uninterrupted flow of blood into the ascending aorta by bypassing the vessel’s damaged part. The first of Hybrid’s three sections is a graft that sturdies the damaged area; the second part, a stent, holds the artery open, and the third is the catheter to affix the device.³ The Hybrid, developed by Vascutek Limited out of Glasgow, received FDA approval last spring. It had received EMA approval a few years ago.

In a presentation last May at the American Association for Thoracic Surgery conference, cardiac surgeon Pierpaolo Chivasso, University Hospital in San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy, said traditional emergency treatment of a dissection usually has not included repair of distal portions of the aorta.⁴ The approach with the Hybrid includes such repair.

In a study of 59 consecutive patients admitted to the hospital with a Type A dissection who received the multibranched Hybrid device, the 30-day mortality rate was 11.8%, the stroke rate was 5%. Renal and respiratory failure that required appropriate intervention was 32%, combined. The survival rate at two years was 72.9%.⁴

1. Aortic Dissection: Causes, Symptoms & Treatments
2. Aortic dissection - Symptoms and causes - Mayo Clinic
3. Thoraflex Hybrid - P210006 | FDA
4. AATS | Systematic Total Arch Replacement with Thoraflex Hybrid Graft

Christine Bahls is a freelance journalist covering the pharmaceutical, clinical trials and medical health technology fields.