Software that allows clinicians a "surgical dress rehearsal" gets FDA nod

By Laura Lovett
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A new product that allows surgeons to pre-plan endovascular treatment of cerebral aneurysms was recently cleared by the FDA. EndoVantages’ SurgicalPreview is a cloud-based computer modeling platform that lets surgeons upload individual patient’s CT scans and then creates a 3D model of the brain with anatomical measurements. 

A cerebral aneurysm, which is a weak spot in the blood vessel of the brain that balloons out and fills with blood, is treated by using a tube-like device to divert blood flow away from the aneurysm, according to Robert Green, president and CEO of EndoVantage. This procedure is delicate because aneurysms could burst or bleed into the brain and cause hemorrhagic stroke or nerve damage. 

“What we have is a surgical dress rehearsal,” Green said . “The way we do that is we upload the patients data, usually a CT scan, we then take that 2D image and turn it into a 3D image that can be fully manipulated on the computer so the surgeon can turn it and twist it and look at it from all different angles. And then we can actually commence computer modeling of one or more stents different types and sizes into that patients vessel. So when they enter the operating room they know exactly what they are doing.”

The new tool is expected to help doctors chose the precise size of the device for a patient’s artery and how to place it correctly. The tool enables clinicians to view stent strategies, calculate aneurysmal volume and neck size and view stent delivery and placement.

Surgeons can also request a computational models of multiple treatment scenarios for the patient. The company reports that these different scenarios include a variety of devices and deployment strategies. It also includes a library of 3D models of neurological treatment devices approved by the FDA that the clinician can select, so they can try out different surgical implements.

Typically when a clinician goes into surgery they have an idea of what type of stent they want and how to deploy it but sometimes it is trial and error, said Green. 

“Now the surgeon has figured that out in his or her office before the surgery,” Green. 

EndoVantage was founded in late 2013 at Mayo Clinic and Arizona State University. The company aims to first bring products to the endovasular and cerebral areas, but has plans to expand to many different parts of the body. Green also said there are many areas where he could see the product used in the future, including research and development of stents and surgical tools.

“This revolutionizes the way medical devices are developed, dramatically shorting development time, speeding time to market, and reducing cost,” said Green.

The app could also be beneficial to doctors with limited experience performing a particular type of surgery. 

“Endovantage provides surgeons and interventionalists with a practical tool to "do the operation before the operation,” Bernard Bendok, MD, Chair, Department of Neurologic Surgery, Mayo Clinic Arizona said in a statement. “This breakthrough technology promises to revolutionize precision surgery by better matching devices to patient specific anatomy. This important advance promises to substantially improve clinical outcomes and reduce risk of procedures. We are approaching a time when preoperative procedural modeling will be considered the standard of care. The tools which have been pioneered by EndoVantage will accelerate the advent of this next new exciting and higher standard in healthcare.”