Abbott snagged an FDA clearance for its new system designed to map out the blood vessels feeding the heart and any potential blockages using a combination of artificial intelligence and optical coherence tomography.
Launched in Europe earlier this year, the device uses laser light to scan the insides of an artery from a small catheter, offering a cross-section view of built-up calcium and plaque, while the company’s Ultreon software helps automate the imaging process.
During a procedure, the AI aims to guide physicians step-by-step through measuring the diameter of the blood vessel and gauging the amount of calcification, ultimately to help select the most optimal placement for a stent.
“As cardiologists continue to adopt OCT and move away from traditional imaging methods such as angiography, emerging technologies are pivotal to determine the best course of patient care,” Nick West, chief medical officer of Abbott’s vascular business, said in a statement.
A company study previously showed that the addition of OCT imaging and a standardized, AI-supported workflow led to physicians altering their treatment strategy for blocked coronary arteries in 88% of cases—based on the thickness of calcium deposits, the location of safe stent landing zones and confirmation of proper expansion.
In addition, with a postprocedure scan, physicians were able to treat damage to the artery following the deployment of a stent, which would have otherwise gone unnoticed under traditional angiography in nearly a third of treated lesions.
The Ultreon software—which works with Abbott’s Dragonfly OpStar imaging catheter and PressureWire X guidewire—has received a CE Mark, and began its European rollout this past April. The platform has also since been approved in Japan.
And to introduce more surgeons to the new technology, Abbott launched its first virtual reality training program for OCT late last year, giving cardiologists the opportunity to test-drive the device in a simulated cath lab.
Abbott hopes that its AI will be a differentiating factor as the use of OCT expands in the field, where its Dragonfly OpStar catheter will compete with Terumo’s Lunawave as well as ultrasound-based devices such as Boston Scientific’s OptiCross.
OCT has also been used in eye care, to measure the thickness of a healthy retina and help diagnose glaucoma and macular edema.