News | Peripheral Artery Disease (PAD) | September 04, 2020

CMS Grants Additional Reimbursement for Eluvia Vascular Stent

Medicare granted a New Technology Add-on Payment (NTAP) for the Boston Scientific Eluvia drug-eluting peripheral stent effective Oct. 1, 2020

The U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the Boston Scientific Eluvia Drug-Eluting Vascular Stent System as part of the 2021 Inpatient Prospective Payment System (IPPS). 

September 4, 2020 — The U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the Boston Scientific 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 Oct. 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.[1,2] 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 CMS determination is a very positive development for patients with PAD and supports what we have confirmed through our clinical trials – the Eluvia stent offers clinically superior outcomes compared to other peripheral drug-coated technology available to clinicians and their patients," said Jeff Mirviss, executive vice president and president, peripheral interventions, Boston Scientific. "The decision is particularly important given the level of consideration and evaluation related to the role of paclitaxel in the peripheral vasculature, and we believe this designation reflects the unique attributes of the Eluvia stent, which are clearly differentiated and improve the quality of life for the millions of people suffering from symptoms of PAD."

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.[3] 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.[4] 

For more information: www.bostonscientific.com/drugeluting

 

Related Peripheral Stent Content:

New Peripheral Stent Technology

Boston Scientific Receives FDA Approval for Eluvia Drug-Eluting Vascular Stent

More news on Peripheral Artery Disease (PAD) technologies

 

References:

1. Centers for Disease Control: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm Accessed July 19, 2019.
2.  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.
3. 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. 
4. Gray WA, Two-year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX. LINC, January 2020.

Related Content

Cardinal Health Sells its Cordis Cardiology Business to Hellman & Friedman. Hopes to build the Cordis Accelerator for innovative cardiovascular device development.
News | Cardiovascular Business | March 12, 2021
March 12, 2021 — Cardinal Health today announced that it is selling its...
An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

News | Cardiovascular Business | February 03, 2021
February 3, 2021 — Modern Vascular is a medical group that has 13 outpatient cath lab clinics to treat...
COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States. #DAIC

COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States.

Feature | Cardiovascular Business | December 01, 2020 | Dave Fornell, Editor
December 1, 2020 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC
Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

News | Cardiovascular Business | September 14, 2020
September 14, 2020 — New global research released by Abbott takes a deep dive into the barriers of cardiovascular pat
Philips angiography system in a cath lab at Henry Ford Hospital.
Feature | Cardiovascular Business | July 13, 2020 | Deb Thompson and Christian Comeau
For a cardiovascular service line leader, addressing challenges in an evolving healthcare climate is a constant.
Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

News | Cardiovascular Business | July 08, 2020
July 8, 2020 – Philips Healthcare and Leeds Teaching Hospitals NHS Trust announced a seven-year managed service agree
Medicare will pay for telehealth virtual doctor visits during the duration of the coronavirus COVID-19 outbreak.
News | Cardiovascular Business | March 17, 2020
March 17, 2020 — The Trump Administration today announced expanded Medicare telehealth coverage that will enable bene