St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced European CE Mark approval of its AMPLATZER ™ Amulet ™ Left Atrial Appendage Occluder. The Amulet device is used to close the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). According to research, AF leads to an increased risk for stroke. Sealing off the LAA helps prevent the risk of blood clot formation and release, potentially reducing the risk of stroke. The next-generation percutaneous transcatheter device leverages the design and clinical success of the original AMPLATZER™ Cardiac Plug with additional features allowing treatment of a wider range of appendage anatomies. St. Jude Medical will be showcasing the new AMPLATZER Amulet device during the eighteenth annual Boston AF Symposium at booth 319.
AMPLATZER Amulet Left Atrial Appendage Occluder. Courtesy of St. Jude Medical. (Photo: Business Wire)
During AF, chaotic electrical signals in the heart’s upper chambers (atria) beat erratically and out of sync with the two lower chambers, resulting in poor blood flow. The LAA is a tube-shaped appendage connected to the left atrium of the heart that can potentially hold static blood during an episode of AF, increasing the likelihood of clot formation. Research shows that in AF patients, approximately 90 percent of all cardiac blood clots form in the LAA. If a clot forms in the LAA and is then released into the heart, it may enter blood circulation, travel to the brain, block a vessel and cause an ischemic stroke. The current standard of care to treat ischemic stroke in AF patients is blood-thinning medications, which comes with a lifetime of medical management and major, sometimes fatal, bleeding risks.
The enhanced AMPLATZER Amulet design was driven by feedback from physicians who have been implanting the AMPLATZER Cardiac Plug in Europe since 2008. Self-expanding and made of braided Nitinol mesh, consistent with the entire family of AMPLATZER devices, the Amulet occluder works by blocking the LAA at its opening, which minimizes the opportunity for blood clots to form in the LAA or migrate into the bloodstream. This next-generation occlusion device is built with a longer lobe and waist than previous versions to allow for easier placement. The end screw is flush with the disc to create a smooth surface within the left atrium, and the larger disc diameter offers increased orifice coverage. The AMPLATZER Amulet device is offered in eight sizes to accommodate varying anatomies. Additionally, the device is pre-loaded into the delivery catheter, which simplifies device preparation and ultimately streamlines the entire procedure for the physician.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV