Cook Medical aortic dissection device gets FDA approval
- Cook Medical said it received FDA approval for its endovascular stent graft system to repair Type B dissections of the descending thoracic aorta in a less invasive procedure than open surgery.
- The device, called the Zenith Dissection Endovascular System, consists of a proximal stent graft component and a distal bare stent component. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert and guide the device into place in the aorta.
- Bloomington, Indiana-based Cook said the device will be available for sale in the United States in the coming months.
Endovascular grafting is increasingly being used to repair aortic aneurysm, a bulge in the aorta carrying blood from the heart through the chest and torso that can rupture from weakening if not diagnosed and treated. Nearly 10,000 people died from aortic aneurysms in 2014 in the United States, according to the Centers for Disease Control and Prevention.
The traditional method of repairing an aortic aneurysm is open surgery in which tubes made of artificial material are positioned inside the aorta and sewn in above and below the bulging section. Endovascular grafting is gaining ground as an alternative thanks to its minimally invasive approach.
Aortic stent grafts are poised to become a $4.5 billion global market over the next decade, bolstered by advances in device design, according to one recent forecast. Among the companies focused on products for the market are Gore Medical and Medtronic.
Medtronic recently received both FDA and CE mark approval for a thoracic endovascular aneurysm repair system designed specifically for patients with small iliac arteries of the pelvis.
With its Zenith endovascular graft, Cook Medical is targeting the device to treat patients with Type B aortic dissection. Aortic dissection is a tear between the inner and middle layers of the aorta. A Type B dissection occurs in the descending aorta, while a Type A dissection involves a tear in the ascending aorta.
Blood flowing through the tear can cause the inner and middle layers of the aorta to dissect, or separate. The thoracic endovascular aortic repair (TEVAR) procedure is intended to prevent malperfusion of aortic branches and aortic rupture, the company said.