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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

IDEV's Pivotal SUPERB Trial Demonstrates SUPERA® Stent Significantly Exceeds VIVA Criteria For One-Year Patency In Femoropopliteal Artery Disease

The SFA and proximal popliteal artery are exposed to significant mechanical stress with bending and rotation of the knee, which represents a harsh environment for any endovascular device. An ideal stent for use in these areas should offer a significant range of motion without interrupting the anatomical function of the arteries.  

"SUPERA is first in a new class of stents engineered with an interwoven wire technology that best mimics vascular anatomy. These results challenge the current dogma of other stent and drug-eluting stent technologies to achieve optimal and durable femoropopliteal arterial patency," noted co-primary investigator Lawrence Garcia, M.D., Chief, Interventional Cardiology and Vascular Interventions at Steward St. Elizabeth's Medical Center.    

"The SUPERA stent design may offer physicians a new option to treat significant disease states in one of the fastest growing markets, which is driven by diabetes, obesity, sedentary lifestyles, an aging population and improved detection," stated Christopher M. Owens, President and CEO of IDEV. "Therapies must have both clinical evidence and an economic benefit approach; SUPERA has significant unmatched advantages in both of these categories. We are extremely pleased with the results from the SUPERB pivotal IDE Trial, which are consistent with other large data sets that are being presented on SUPERA at the VIVA conference."

Data from the SUPERB trial will be utilized for IDEV's premarket approval (PMA) application with the FDA, which the Company anticipates filing in the fourth quarter of 2012. The SUPERB trial data is consistent with and validates the numerous reported single-center registries and retrospective studies and is an exciting piece of the growing wide-body of clinical evidence that IDEV is delivering on SUPERA.

"SUPERB enrollment and follow up rates were well beyond the stated study goal and ensure that results are credible and that the study was performed to the highest current standards," said Laura Mauri of Harvard Clinical Research Institute (HCRI).

About SUPERBThe SUPERB Trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) is an FDA approved IDE trial to evaluate SUPERA in treating patients with obstructive SFA disease.

SUPERB data analysis was performed independently and validated by the Harvard Clinical Research Institute (HCRI).

2 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 16,919.59 +80.85 0.48%
S&P 500 1,981.60 +9.86 0.50%
NASDAQ 4,527.5140 +19.2020 0.43%

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