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

News | Cardiovascular Business

December 7, 2022 — Ultromics has announced that its EchoGo Heart Failure, an artificial intelligence (AI) platform for ...

Home December 07, 2022
Home
Feature | Cardiovascular Business

Here is a recap of what DAIC viewers found most interesting during the month of November: 1. Study Finds That Risk of ...

Home December 05, 2022
Home
Feature | Cardiovascular Business | By Merilee Kern, MBA

Numerous indicators make clear that the next five years will usher in extreme transformation for a multitude of ...

Home November 09, 2022
Home
News | Cardiovascular Business

November 1, 2022 — Deepak L. Bhatt, MD, MPH, a top expert in cardiovascular medicine and interventional cardiology, has ...

Home November 01, 2022
Home
Feature | Cardiovascular Business

November 1, 2022 — Johnson & Johnson and Abiomed, a world leader in breakthrough heart, lung and kidney support ...

Home November 01, 2022
Home
Feature | Cardiovascular Business | By Melinda Taschetta-Millane

Here is what you and your colleagues found to be most interesting in the fields of diagnostic and interventional ...

Home November 01, 2022
Home
News | Cardiovascular Business

October 31, 2022 — The Yale School of Medicine announced the passing of Robert W. Berliner Professor Emeritus of ...

Home October 31, 2022
Home
News | Cardiovascular Business

October 24, 2022 — Asher Kimchi, MD, clinical chief of Cardiology, vice-clinical chief of the Department of Medicine ...

Home October 24, 2022
Home
News | Cardiovascular Business

October 20, 2022 — Atlas Healthcare Partners – which specializes in developing and managing ambulatory surgery centers ...

Home October 20, 2022
Home
News | Cardiovascular Business

October 19, 2022 — Mount Sinai Health System’s globally acclaimed cardiologist Valentin Fuster, MD, PhD, has been named ...

Home October 19, 2022
Home
Subscribe Now