Nov 12, 2015 | By Kira
Dr. Ben Starnes, Chief of Vascular surgery at the University of Washington and Chief Medical Officer at Aortica, has pioneered a new treatment for abdominal aortic aneurysms that combines patient-specific CT scans with proprietary software to create life-size 3D printed models of the patient’s aorta. These models can then be used as a template to customize commercially available stent grafts, making life-saving surgery possible for up to 20,000 patients who did not previously qualify. Aortica's proprietary planning tool for vascular surgeons is expected to be available within the next two to three years.
Abdominal aortic aneurysms (AAA) affect up to 180,000 Americans annually. Considered a ‘silent killer’, AAAs are characterized by abnormal bulges in the wall of the aorta (the largest artery in the human body), that often grow undetected. As the aneurism grows, the risk of rupture increases, leading to 15,000 deaths in America every year. If detected in time, abdominal aortic aneurysms’ can be repaired with surgery—typically, an operation known as EVAR (endovascular aortic repair)—however approximately 30-40% of patients diagnoses are not eligible for EVAR due to anatomical abnormalities.
“An aorta is like a tree trunk,” explains Starnes. “The limbs that extend from the three trunk are very important because they feed the kidneys, liver, and stomach with oxygenated blood. When performing an endovascular repair, the surgeon wants to avoid blocking those branches, but this is challenging because every patient’s aortic anatomy is different.”
Aortica President and CEO Tom Douthitt continues: “Current endografts require a minimum of 15 mm of healthy aorta just above the aneurismal segment in order to be anchored properly. Most physicians would say you need even more than that. If an endograft is not sealed properly, then the patient will experience a leak down the outside of the graft, and the underlying aneurism will not be addressed, and could even worsen.”
Currently, customized endografts are available for patients who are not eligible for EVAR surgeries, however they can only be purchased from a company in Australia, often at a high price and with limited options for patient-specific care. The only other option for these patients is to undergo a far riskier invasive open surgery that, for the most part, doctors stopped using in the 1990s.
Aortica’s proposed solution, developed by Starnes, is known as a PMEG—Physician Modified Endovascular Graft. With the PMEG, Starnes can create two to three holes (fenestrations) in the upper portion of the graft based on measurements made from the patient’s CT scan. This allows the graft to be located higher into the healthy segment of the aorta without blocking blood flow.
Starnes uses an ophthalmic Bovie cautery device to create the fenestrations, thus avoiding fabric fraying.
However, in order to ensure that the process can be replicated by any vascular surgeon and tailored to specific patient needs, Starnes and Aortica are developing a method that would use 3D printing to replicate exactly the patient’s aortic anatomy. The 3D printed mold thus acts as a guide, showing surgeons exactly where to make the fenestrations. “[The graft] is going to fit like a glove. Why wouldn’t it? We just used your aorta as a template for that,” said Starnes.
In addition to the 3D modeling technique, Aortica is developing a 'planning tool' to be implemented in hospitals that treat AAA. The company has two pending patents and a licensing agreement with the University of Washington for the software.
With the planning tool, vascular surgeons will be able to electronically upload the patient’s CT scan to the company’s website, where the scan will be entered into Aortica’s proprietary software to account for various nuances and interactions between the patient’s anatomy and the endograft to be implanted. Using this data, the aorta model is 3D printed and mailed to the surgeon overnight, ready to assist with the surgery. “There is no learning curve, and it takes about 45 minutes to modify the implant for a perfect fit,” said Starnes of the planning tool.
According to the company, nearly half of the EVAR procedures performed yearly in the US could benefit from Aortica’s planning template, not to mention the 20,000 patients each year who would not longer have to face complicated open surgery. In addition, the template is complimentary to commercially available grafts.
Dr. Ben Starnes
Last year, Aortica received $7 million in Series A financing to complete an FDA study of their technique. It has since become the only FDA-approved PMEG study in the United States. Moving forward, the 3D printed templates will be used in Starnes’ investigator-initiated investigational device exemption (IDE) study, administered in conjunction with Harborview Medical Center.
As for bringing this technique to the market so that the thousands of patients in need can begin to benefit from it, CE mark is expected as early as 2017, with US approval following one year later. The product will sell for between $5,000 and $10,000 per procedure.
Posted in 3D Printing Application
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