This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Access To Abbott's MitraClip® System Expands In The U.S. With Medicare National Coverage Determination

ABBOTT PARK, Ill., Aug. 12, 2014 /PRNewswire/ -- The Centers for Medicare & Medicaid Services (CMS) recently issued a National Coverage Determination (NCD) that extends coverage for Medicare beneficiaries in the United States to Transcatheter Mitral Valve Repair with Abbott's (NYSE: ABT) MitraClip ® System. The MitraClip System is a first-of-its-kind device that provides new hope for people with severe degenerative mitral regurgitation who are not good candidates for surgery. Treatment with MitraClip can significantly improve symptoms and quality of life by reducing the backward flow of blood through the mitral valve in the heart.

The NCD provides a national framework for Medicare coverage that can help people gain more timely access to the MitraClip treatment if they meet the eligibility requirements, which are based on CMS's analysis of the clinical evidence supporting the device. Multiple trials, published reports, and registries of people treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients.

CMS also approved a New Technology Add-On Payment (NTAP) for the MitraClip System earlier this month, recognizing the substantial clinical benefits of this breakthrough innovation. The NTAP is designed to promote hospital adoption of new technologies that could benefit Medicare beneficiaries by enabling hospitals to obtain supplemental funding.

"We commend the extensive collaborative efforts of the CMS, FDA and medical societies in achieving this significant milestone of establishing a national coverage framework for Transcatheter Mitral Valve Repair," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The National Coverage Determination and the New Technology Add-On Payment are important steps in helping people who need the MitraClip therapy gain timely access to treatment."

Mitral regurgitation is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood in the heart. The condition can raise the risk of irregular heartbeats, stroke, and heart failure, which can be deadly. Mitral regurgitation is common, affecting more than 4 million Americans – nearly one in 10 people aged 75 and above. 1 Open heart mitral valve surgery is the standard of care treatment, but many people are at prohibitive risk for an invasive procedure. Medications for the condition are limited to symptom management and do not stop the progression of the disease.

Abbott's MitraClip System repairs the mitral valve in people with severe degenerative mitral regurgitation without the need for an invasive surgical procedure. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving quality of life. People undergoing the MitraClip treatment typically experience short recovery times and short hospital stays of two to three days. MitraClip was approved by the U.S. Food and Drug Administration (FDA) in October 2013 and received CE Mark in 2008. After FDA approval, CMS initiated an NCD based on a multi-society request from the Society of Thoracic Surgeons (STS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and American Association for Thoracic Surgery (AATS).

About MitraClip

The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR  > 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. More information, including important safety information, can be found at

About Abbott Vascular

Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $94.19 0.00%
FB $118.06 0.00%
GOOG $695.70 0.00%
TSLA $222.56 0.00%
YHOO $37.40 3.90%


Chart of I:DJI
DOW 17,651.26 -99.65 -0.56%
S&P 500 2,051.12 -12.25 -0.59%
NASDAQ 4,725.6390 -37.5850 -0.79%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs