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

DEFINITIVE LE Study Confirms That Directional Atherectomy With Covidien's TurboHawk(TM) Device Is An Effective Frontline Therapy When Treating PAD In Diabetic And Non-diabetic Patients (Photo: Business Wire)

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced final 12-month results from its DEFINITIVE LE (Determination of Effectiveness of SilverHawk™ / TurboHawk™ Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels/Lower Extremities) study.

DEFINITIVE LE study confirms that directional atherectomy with Covidien's TurboHawk(TM) device is an ...

DEFINITIVE LE study confirms that directional atherectomy with Covidien's TurboHawk(TM) device is an effective frontline therapy when treating PAD in diabetic and non-diabetic patients (Photo: Business Wire)

DEFINITIVE LE is the largest peripheral atherectomy study conducted to date with independent physician review of the outcomes. The study, which enrolled 800 patients at 47 centers in the U.S. and Europe, demonstrated the long-term effectiveness of directional atherectomy as a frontline therapy for the treatment of peripheral arterial disease (PAD). Directional atherectomy is a minimally invasive treatment that removes plaque from the body and restores blood flow in the native artery.

“For the first time, the DEFINITIVE LE study has provided robust evidence within a large and diverse PAD patient population,” said Lawrence A. Garcia, M.D., Chief of Interventional Cardiology and Vascular Interventions at St. Elizabeth's Medical Center in Boston. “Directional atherectomy, with the SilverHawk and TurboHawk devices, delivers patency results at 12 months post-treatment that are comparable to those reported in stent studies—and with the important advantage of not leaving anything behind in the vessel.”

DEFINITIVE LE 12-Month Efficacy and Safety Results

Clinical outcomes were improved by 30 days and sustained through 12 months of follow-up. Directional atherectomy with the SilverHawk and TurboHawk devices delivered 12-month patency results that were comparable to those reported in stent studies.

Among patients with claudication, primary patency (i.e., the treated artery remained open) was 78% using a peak systolic velocity ratio (PSVR) < 2.4 at 12 months. Notably, this rate did not differ between patients with diabetes (77%) and those without diabetes (78%)—the first such results to be shown in a prospective, powered analysis. Among patients with critical limb ischemia (CLI - a severe form of PAD), 95% were able to avoid a major unplanned amputation of the target limb. The SilverHawk and TurboHawk devices were shown to have a strong safety profile in the study, with low complication rates.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

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.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!
DOW 17,131.97 +100.83 0.59%
S&P 500 1,998.98 +14.85 0.75%
NASDAQ 4,552.7590 +33.8570 0.75%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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