Pi-Cardia announced today that CMS approved reimbursement for its ShortCut leaflet modification device for TAVR procedures.
CMS granted a new technology add-on payment (NTAP) for eligible cases using ShortCut. This designation recognizes ShortCut as a breakthrough technology that addresses a critical unmet need in valve-in-valve transcatheter aortic valve replacement (TAVR). It enables treatment for patients at risk of coronary obstruction.
NTAP facilitates Medicare beneficiary access to new technologies that offer substantial clinical improvement over existing technologies. It provides supplemental payments to help offset adoption costs. This also enables CMS to collect cost data to inform future payment rates.
What this means for Pi-Cardia
Beginning on Oct. 1, CMS intends to provide eligible hospitals with up to $9,750 in additional reimbursement per case with ShortCut procedures. This payment adds to the Medicare Severity Diagnosis-Related Group (MS-DRG) amount for TAVR.
The Boston-based company designed ShortCut to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after transcatheter aortic valve replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).
ShortCut enables valve-in-valve TAVR procedures in patients at risk of coronary obstruction. The company says it represents the world’s first dedicated device designed to split the leaflets prior to valve treatment. Pi-Cardia won FDA clearance for the ShortCut device in September 2024. It announced the first commercial cases in March.
“We are thrilled to get CMS NTAP for the ShortCut device,” said Erez Golan, Pi-Cardia CEO. “We started our U.S. limited commercial launch just a few months ago at leading TAVR centers and already see significant utilization and enthusiasm with the device. The NTAP will now allow us to expand our commercial footprint, enabling more hospitals to adopt ShortCut with additional reimbursement support—and ultimately helping more patients at risk of coronary obstruction gain access to this important technology.”
