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

AtriCure Update On DEEP AF Feasibility Trial - Call Transcript

Stocks in this article: ATRC

During the staged hybrid procedure, the minimally invasive surgical ablation is performed first and catheter optimization is scheduled separately. In addition, the investigators discussed recruiting new sites for a pivotal trial and a review of the initial clinical results.

The scheduling and logistics aspects of performing the hybrid procedure in the same session can present certain challenges. Although three of the five investigational sites were advocating to continue with the same-session procedure, all the investigators agreed that during the learning curve period, having the surgeon perform the minimally invasive procedure in their operating room and having the electrophysiologist perform their catheter optimization procedure in their EP lab may reproduce and lessen complications and alleviate the logistical challenges of integrating this procedure into certain new investigational sites.

In terms of safety, a report of the adverse events was presented to the investigators and the results were considered acceptable by the investigators given that the patients are subject to the cumulative risk of a minimally invasive surgical procedure as well as a catheter based procedure and that the treatment options for the study population are limited.

A total of seven primary adverse events, including one stroke occurring on postoperative day 27, resulting in death on day 30, were reported to the investigators and discussed interactively throughout the meeting. No adverse events were attributed to the investigational device. Importantly, the investigators recommended that we continue to discussions with FDA concerning the need for including a severity index into the clinical protocol in order to more accurately assess the risk-benefit profile of this investigational procedure and system.

In the interim, it was recommended that adverse events should be further graded as mild, moderate, or severe. In addition, the independent physician adjudicator presented a report to the DSMB and characterized all of the events as mild or moderate, except for the aforementioned stroke and subsequent death.

3 of 4

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 17,719.00 +33.27 0.19%
S&P 500 2,052.75 +4.03 0.20%
NASDAQ 4,701.8670 +26.1550 0.56%

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