Philips (NYSE:PHG) said the FDA granted 510(k) clearance for its 3D planning software for a type of heart valve replacement procedure, part of Philips’ IntelliSpace Portal 6 visualization and analysis platform.
The planning software for transcatheter aortic valve implantations "features a comprehensive measurement package to accommodate virtually all types of TAVI devices," according to a press release.
"As our population ages, minimally invasive TAVI procedures are becoming increasingly popular in the United States, since they provide a non-surgical option for those patients who might have once been considered too high-risk for heart surgery," Philips Healthcare imaging systems CEO Gene Saragnese said in prepared remarks. "Treating cardiac conditions requires intense precision and our TAVI planning application delivers a solution for aortic device placement to help improve patient care."
The TAVI planning application uses computed tomography imaging to generate planes and panel measurements for the placement of TAVI devices, aiming to ensure the correct size implants is used, according to the release.
The TAVI technology received FDA approval in 2011. A minimally-invasive procedure, TAVI became a major breakthrough option for high-risk patients who were deemed non-surgical candidates. This procedure can reduce mortality by 60 percent as compared to conventional surgeries1.
Edwards Lifesciences (NYSE:EW) was 1st to the U.S. market with a TAVI device, its Sapien valve, which the FDA approved in November 2011. Medtronic (NYSE:MDT) followed in January of this year with the CoreValve device it acquired for $700 million plus milestones in 2009.