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

Merit Medical Announces Multiple Regulatory Approvals

Stocks in this article: MMSI

SOUTH JORDAN, Utah, July 1, 2013 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received multiple regulatory approvals from various regulatory bodies.

The basixTOUCH™, Merit's most advanced high-pressure inflation device, has received 510(k) clearance from the FDA. The "Touch," which attained the CE mark early in the second quarter of 2013, has had substantial success in the first two months of its European release. The "Touch" eliminates the need to use multiple inflation devices in some advanced interventional cases because of its high pressure range. The Company also received initial acceptance of a number of claims from its U.S. patent application.

"We believe the introduction of the basixTOUCH clearly places Merit in the worldwide leadership position for inflation devices which are used in numerous interventional and peripheral procedures," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "The features of this device can also be applied to other inflation products such as the Blue Diamond™ digital inflation system. This device and its derivatives have the potential, when combined with other devices such as our hemostasis valves, to become the largest single revenue producing product in Merit's history."

Merit also announced that it has been notified by its embolic business partner in Japan, Nippon Kayaku, that it has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for Embosphere® and HepaSphere™ Microspheres as medical devices for the purpose of arterial embolization in patients with hypervascular tumors and arteriovenous malformations.

"We are pleased with the substantial efforts of our partner to bring this highly needed product to the people of Japan," Lampropoulos said. "Initial shipments are scheduled to begin in the third quarter of 2013."

Merit also announced that it has received 510(k) clearance for its Bearing™ nsPVA Embolization Particles. 

1 of 2

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 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

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