CE marked back in 2013, Cook Medical has now received U.S. FDA approval for its lower-profile Zenith Alpha™ Thoracic Endovascular Graft.
Zenith Alpha Thoracic is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections), defined as having vascular anatomy suitable for endovascular repair. This includes the presence of nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion with a length of at least 20 mm, and with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
The approval of Zenith Alpha Thoracic was based on two pivotal clinical trials that studied the safety and effectiveness of the device in patients with aortic aneurysm/ulcer or blunt traumatic aortic injury.
Zenith Alpha Thoracic will allow physicians to treat more patients with TEVAR (thoracic endovascular aortic repair) because of its lower-profile introduction system and broad range of sizes. With a 16-20 French delivery system, Zenith Alpha Thoracic was developed to address vascular access issues associated with larger-profile devices and to increase conformability in tortuous anatomy.
The device’s introduction system also boasts an ergonomic design that requires fewer procedural steps than previous designs to deploy the device without sacrificing the precision and control of the Zenith platform.
“Despite all the successes we’ve seen over the past few decades in endovascular aneurysm repair, we continue to be frustrated when we have to put a large sheath through iliac arteries that are smaller than the delivery system,” said paid investigator, Karl Illig, MD, Professor Surgery and director of the division of Vascular Sugary at USF Morsani College of Medicine. “Development, testing, and now approval of the Zenith Alpha Thoracic device is long-awaited in this regard.”
“The approval of Zenith Alpha Thoracic accelerates Cook Medical’s vision to provide physicians with disease-specific treatment options that fit each patient’s unique anatomy and disease state,” said Nicky James, vice president and global business unit leader of Cook Medical’s Aortic Intervention division.
Source: Business Wire