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
See Cramer's multi-million dollar portfolio for FREE and get his new book Get Rich Carefully! Learn More

Boston Scientific Lotusa¿¢ Valve System Meets Primary Performance Endpoint In REPRISE II Trial

San Francisco, Oct. 31, 2013 /PRNewswire/ -- The Boston Scientific Corporation (NYSE: BSX) Lotus™ Valve System met a key performance measure in the treatment of symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement, according to new data released today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco. 

Data presented as a First Report Investigation by Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II Trial, demonstrated that the Lotus Valve System, which was implanted successfully in all 120 patients, met the primary device performance endpoint at 30 days with no severe paravalvular aortic regurgitation (leaking).

The Lotus Valve System is a differentiated second generation transcatheter aortic valve replacement (TAVR) device designed for total control. It is both fully repositionable and retrievable prior to release, with a unique Adaptive Seal™ technology designed to minimize paravalvular aortic regurgitation, a proven predictor of mortality. 1,2,3

"The results from the REPRISE II trial continue to demonstrate the benefits of the Lotus Valve System, particularly the ability to position the valve accurately the first time, while having the advantage of full retrieval if needed," said Meredith. "In all 120 patients, the Lotus Valve System was successfully implanted and positioned appropriately with negligible aortic regurgitation while reporting low 30-day all-cause mortality and major stroke rates in this sick patient population. This is a testament to the advancement in technology that the Lotus Valve System offers."

REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. REPRISE II is being extended to enroll an additional 130 patients at twenty sites in Australia and Europe.

Key findings included:

  • The primary device performance endpoint assessed by an independent core lab was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2 mmHg was significantly (P<0.001) less than the performance goal of 18 mmHg. 
  • The primary safety endpoint, defined as all-cause mortality at 30 days, was 4.2 percent.
  • Independent core lab assessment of paravalvular aortic regurgitation at 30 days indicated no severe regurgitation and one case of moderate regurgitation (1.0 percent).  In 5.2 percent of patients regurgitation was considered trace and in 78.4 percent of patients there was no paravalvular regurgitation at 30 days.
  • No instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
  • The disabling stroke rate for the 120 patients at 30 days was 1.7 percent.

One-year results from REPRISE I, a prospective, single-arm feasibility study on patients with severe symptomatic aortic stenosis conducted in Australia, were presented in May at EuroPCR by Professor Meredith and published online ahead of print by EuroIntervention. The data demonstrated sustained safety and performance of the Lotus Valve out to one year with no new major adjudicated events, as defined by the Valve Academic Research Consortium (VARC), and no moderate or severe paravalvular aortic regurgitation in any patient.

"These new results from the REPRISE clinical trial program, and particularly those from the REPRISE II trial, underscore the unique technology behind the Lotus Valve System," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "These features lead to a predictable implantation procedure and may result in improved clinical outcomes. The Lotus Valve offers a novel TAVR option for patients with severe aortic valve disease considered at high risk for surgical valve replacement."

Stock quotes in this article: BSX 

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.
DOW 16,424.85 +162.29 1.00%
S&P 500 1,862.31 +19.33 1.05%
NASDAQ 4,086.2250 +52.0640 1.29%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto
Advertising Partners

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