Aortica Completes First Two Cases Using the AortaFit System.
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- US-based medical technology company Aortica Corp. has completed the first two cases using their AortaFit system to support simplified fenestrated endovascular aneurysm repair (FEVAR), the company said.
Two procedures were performed by Dr. Benjamin Starnes, Chief of Vascular Surgery at the University of Washington, as part of his physician-sponsored IDE study.
The AortaFit System is an investigational surgical planning tool comprised of Aortica's Fenestration Alignment Software and a patient-specific 3D-printed fenestration template.
In both cases, the presence of branch arteries near the aneurysms and angulated patient anatomy limited the available treatment options.
Using only a CT scan, the Aortica software analysed each patient's native aorta and determined how each endograft would influence the vessel geometry once implanted. Using this information, the software precisely determined the appropriate locations of fenestrations (or holes in the graft) to align with the branch arteries.
A 3D printer then generated patient-specific AortaFit templates that Dr. Starnes used in the operating room to guide his modification of each graft. Standard "off-the-shelf" Medtronic and Bolton Medical endografts were used in these first two cases.
By accounting for the branch arteries, the grafts provided a more secure fixation and seal while still allowing for blood to continue to flow to vital organs fed by the branch arteries.
Each year between 150,000 and 180,000 people in the United States are diagnosed with abdominal aortic aneurysms.
An aneurysm is a large bulge in the aorta (the largest artery in the human body). It can gradually expand over time--without any symptoms--until it bursts, causing massive internal bleeding that results in death if not treated at a specialised center immediately.
For years, major open surgery was the only treatment option, which is risky due to its complicated nature and because it carries a 3.0% mortality rate within 30 days of surgery.
In the 1990's, a new technique for controlling aneurysms was developed using a graft inserted through the femoral arteries.
This technique is called endovascular aneurysm repair. EVAR is significantly less invasive than open surgery and is associated with a mortality rate six times lower. Patients recover faster, leave the hospital sooner, and return to activities of normal daily life more quickly.
Consequently, EVAR has become the gold standard for treatment of AAA disease.
Aortica was founded to design, manufacture, and market tools for treatment of patients with AAA disease who have aortic anatomy that limits their treatment options.
While EVAR has become a highly desirable option for treatment of AAA disease, approximately 40% of patients are not candidates for EVAR because their aortic anatomy is structured in a manner that does not allow an endograft to be anchored properly without blocking blood flow to vital organs.
These patients face either open surgery or may be treated sub-optimally with standard EVAR. Aortica is focused on simplifying Fenestrated EVAR (FEVAR), and advancing the science of Personalized Vascular Therapy.
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|Date:||Feb 11, 2016|
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