News | Embolic Protection Devices | August 03, 2018

Boston Scientific Closes Claret Medical Acquisition, Announces Positive Reimbursement Decision

CMS grants NTAP designation for the Sentinel Cerebral Protection System

Boston Scientific Closes Claret Medical Acquisition, Announces Positive Reimbursement Decision

August 3, 2018 — Boston Scientific Corp. announced it has recently closed its acquisition of Claret Medical Inc., a privately-held company that developed and commercialized the Sentinel Cerebral Embolic Protection System. The device is U.S. Food and Drug Administration (FDA)-cleared to protect patients against the risk of stroke in transcatheter aortic valve replacement (TAVR) procedures.

Boston Scientific also announced that the U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) designation for the Sentinel system.

The NTAP designation was granted as part of the federal fiscal year 2019 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, 2018.

The Sentinel System – which received CE Mark in 2014 and FDA clearance in 2017 – is the only device commercially available used to protect patients against the risk of stroke during TAVR, a minimally-invasive procedure to replace the aortic valve in patients with severe aortic stenosis. Embolic debris such as calcium or tissue can break loose during the procedure, travel through the bloodstream towards the brain and potentially cause neurological and neurocognitive damage. Recent studies have estimated approximately four percent of patients experience a clinically-apparent stroke within 30 days of a TAVR procedure.1,2,3,4,5,6 The landmark SENTINEL trial, which led to regulatory clearance, demonstrated that the Sentinel System reduced the incidence of strokes by 63 percent within the first 72 hours of the procedure.7  

Boston Scientific announced a definitive agreement to acquire Claret Medical on July 20, 2018 for $220 million in up-front cash with an additional $50 million payment for reaching a reimbursement-based milestone, which has been fulfilled with the recent NTAP designation.

For more information: www.bostonscientific.com

 

References

1. Leon, et al., N Engl J Med. 2010;363:1597-1607.

2. Webb, et al., J Am Coll Cardiol Intv. 2015;8:1797-1806.

3. Smith, et al., N Engl J Med. 2011;364:2187-98.

4. Leon, et al., N Engl J Med 2016;374:1609-20.

5. Popma, et al., J Am Coll Cardiol 2014;63:1972-81.

6. Adams, et al., N Engl J Med 2014;370:1790-98.

7. Kapadia S, et al. JACC. Jan 2017; 69(4): 367-377.

Related Content

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
Recognized as the “Pulitzer Prize of the business press,” the Jesse H. Neal Award finalists are selected for exhibiting journalistic enterprise, service to the industry and editorial craftsmanship
News | Cardiovascular Business | February 19, 2020
February 19, 2020 — Connectiv, a division of The Software and Information Industry Association (SIIA), has announced
 Cath Lab Philips Azurion angiography PCI
News | Cardiovascular Business | December 30, 2019
December 30, 2019 — Most patients do not understand or recall information given to them before heart procedures.