This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
TheStreet Open House

The AMPLATZER(TM) Cardiac Plug (Photo: St. Jude Medical, Inc.)

Stocks in this article: STJ

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the first patient implant in a new pivotal trial evaluating the company’s AMPLATZER™ Cardiac Plug (ACP) for the prevention of stroke. The AMPLATZER Cardiac Plug Clinical Trial (ACP Trial) is designed to determine if the ACP device is safe and effective in preventing thrombus (blood clots) from migrating out of the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AF) who have a high risk for stroke.

The AMPLATZER(TM) Cardiac Plug (Photo: St. Jude Medical, Inc.)

The AMPLATZER(TM) Cardiac Plug (Photo: St. Jude Medical, Inc.)

The ACP Trial is a prospective, randomized, multi-center clinical study with an adaptive trial design that will enroll no fewer than 400 and no more than 3,000 patients at up to 90 sites in the U.S. and Canada. The trial compares the safety and efficacy of the ACP device to traditional medical treatment using long-term, blood-thinning medication.

Dr. Christian Machado, director of electrophysiology at the Providence Hospital Heart Institute, Southfield, Mich., and investigator in the study, performed the first AMPLATZER Cardiac Plug implant in the pivotal phase of the trial. The procedure was assisted by Dr. Thomas Forbes, a pediatric interventional cardiologist who is also an investigator in the study.

“Patients with untreated atrial fibrillation are four to five times more likely to have a stroke, which greatly increases their risk of disability or death. Dr. Forbes and I consider the ACP Trial an important study as we look for ways to reduce this risk,” said Dr. Machado. “We are excited to contribute research that may help expand treatment options for patients.”

The AMPLATZER device has been the market leader for LAA occlusion since its introduction in 2008. A self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter, the ACP device is designed to completely seal the LAA (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.

According to the American Heart Association, an estimated 2.7 million Americans have AF and the likelihood of developing it increases with age. Defined as a quivering or irregular heartbeat (arrhythmia), AF can lead to blood clots, stroke, heart failure and other heart-related complications. AF is the most common heart rhythm abnormality in people over the age of 65.

During episodes of AF, the heart contracts at rapid and irregular intervals, which can increase the likelihood of clot formation in the LAA. If a clot is released from the LAA, it can enter the blood stream and potentially travel to the brain, resulting in a stroke.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,191.37 -195.84 -1.13%
S&P 500 2,002.16 -27.39 -1.35%
NASDAQ 4,637.9940 -43.5030 -0.93%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs