Pi-Cardia has announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for the ShortCut leaflet splitting device, effective 1 October 2025.
The NTAP designation recognises ShortCut as a breakthrough technology that addresses a critical unmet need in valve-in-valve transcatheter aortic valve implantation (TAVI) by enabling treatment for patients at risk of coronary obstruction.
CMS will provide eligible hospitals with up to US$9,750 in additional reimbursement per case when the ShortCut procedure is performed. This payment is in addition to the Medicare Severity Diagnosis Related Group (MS-DRG) amount for TAVI. To receive the NTAP, hospitals must report ICD-10-PCS code X28F3VA, which specifically identifies leaflet splitting procedures performed with ShortCut.
“We are thrilled to get CMS NTAP for the ShortCut device,” said Erez Golan, Pi-Cardia’s chief executive officer. “We started our US limited commercial launch just a few months ago at leading TAVI centres and already see significant utilisation 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.”
As bioprosthetic valves degenerate over time, many of these patients will eventually require a valve-in-valve procedure. A significant portion of them who are at risk for coronary obstruction may benefit from leaflet splitting with ShortCut.
According to models recently published in the Structural Heart Journal, by 2035 more than 40,000 valve-in-valve procedures will be performed annually in the USA, representing over 15% of all TAVI procedures. Planned future indications in native and bicuspid valves could make leaflet modification necessary in ~30% of TAVI cases, to ensure safety, reduce complications and improve patient outcomes.
The NTAP program is intended to facilitate Medicare beneficiary access to new technologies that offer substantial clinical improvement over existing technologies. It provides hospitals with supplemental payments to help offset adoption costs while enabling CMS to collect cost data that will inform future inpatient payment rates.
