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MARLBOROUGH, Mass. , Sept. 3, 2020 /PRNewswire/ -- Boston Scientific (NYSE: BSX ) announced that the U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the Eluvia™ Drug-Eluting Vascular Stent System as part of the 2021 Inpatient Prospective Payment System (IPPS). The NTAP designation, awarded to new medical devices determined to substantially improve the diagnosis or treatment of Medicare beneficiaries, will be effective on October 1, 2020 and will provide eligible hospitals with incremental reimbursement for the Eluvia stent system for up to three years. The Medicare criteria for an NTAP designation is based on newness of the device, cost and a substantial clinical improvement.
The Eluvia stent system was developed for the treatment of peripheral artery disease (PAD) – the narrowing of the arteries of the legs due to plaque buildup – which affects approximately 8.5 million people in the United States and more than 200 million people worldwide.[i] , [ii] Left untreated, PAD restricts blood flow to the legs and feet and patients often experience pain, swelling and a diminished quality of life. The Eluvia stent re-opens the blocked artery and restores blood flow, while also utilizing a drug-polymer combination to offer a sustained, low-dose release of drug to prevent tissue regrowth within the stented artery.
The NTAP designation will support access to the Eluvia stent for Medicare beneficiaries in the hospital inpatient setting, making it possible for eligible hospitals to receive NTAP payment in addition to the standard Medicare Severity Diagnosis Related Group (MS-DRG) payment.
The FDA approval of the Eluvia stent system in September 2018 was based on findings from the IMPERIAL trial, which exhibited the highest 24-month primary patency reported to date for the treatment of femoropopliteal disease in a U.S. pivotal trial with a drug-coated balloon or drug-eluting stent.[iii] Trial data confirmed a statistically significant lower clinically-driven target lesion revascularization (TLR) rate of 12.7% for patients treated with the Eluvia stent, in contrast to 20.1% observed within the Zilver® PTX® Drug-Eluting Peripheral Stent cohort (p=0.0495), thus reducing the need for repeat procedures at 24 months.[iv]
Additional information on the Eluvia stent system can be found online at www.bostonscientific.com/drugeluting .
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Karin Dalsin Media Relations (763) 494-1914 (office) [email protected]
Susie Lisa , CFA Investor Relations (508) 683-5565 (office) [email protected]
i Centers for Disease Control: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm Accessed July 19, 2019 . ii Shu, J. & Santulli, G. (2018, August). Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis Journal, 275 (1), 379-381. doi: https://doi.org/10.1016/j.atherosclerosis.2018.05.033 . iii Highest-two year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver PTX RCT. iv Gray WA, Two-year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX. LINC, January 2020 .
SOURCE Boston Scientific Corporation