This Day On The Street
Continue to site
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

CORRECTING And REPLACING Medtronic IN.PACT Drug-Eluting Balloon Studies Show Significant Benefit Of Novel Medical Device In Treating Narrowed Arteries

In addition, rates of major adverse cardiac events (MACE) between the two groups were similar at six months:

  • MACE – IN.PACT Falcon DEB 10.0%, Taxus DES 16.3%
  • death – IN.PACT Falcon DEB 1.1%, Taxus DES 1.1%
  • myocardial infarction (MI) – IN.PACT Falcon DEB 1.1%, Taxus DES 5.5%
  • target lesion revascularization (TLR) – IN.PACT Falcon DEB 4.4%, Taxus DES 7.7%
  • target vessel revascularization (TVR) – IN.PACT Falcon DEB 7.8%, Taxus DES 11.0%

Importantly for assessing the results, nearly two-thirds (64.9%) of the vessels treated in the BELLO study with Medtronic’s IN.PACT Falcon DEB were smaller than 2.25 mm in diameter, for which no DES is currently available.

PACIFIER

The PACIFIER (Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis) study enrolled 91 patients across three hospitals in Germany. The one-year results demonstrated a statistically significant advantage in preventing the superficial femoral artery (SFA) from renarrowing when using the Medtronic IN.PACT Pacific drug-eluting balloon versus conventional, uncoated balloons.

On the primary endpoint results of LLL at six months, there was a statistically significant difference (p = 0.0014) and exceedingly low rate (-0.01mm) of LLL associated with the use of Medtronic’s IN.PACT Pacific drug-eluting balloon compared to patients treated with an uncoated balloon (0.65mm). PACIFIER also significantly favored the IN.PACT Pacific drug-eluting balloon on a composite of death, amputation, and the need for target lesion revascularization (TLR) at one year (7.1% versus 34.9%, p=0.002).

“While preliminary drug-eluting balloon data from uncontrolled trials have been promising, the interventional community has eagerly awaited the results from a randomized trial to validate the clinical benefit of Medtronic’s IN.PACT drug-eluting balloons,” commented Michael Werk, M.D., assistant medical director for the Department of Radiology at the Martin Luther Hospital in Berlin and PI and presenter of the PACIFIER trial. “Earlier research has hypothesized that drug-eluting balloons can reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization, and now the one-year results of PACIFIER show, in a randomized forum, to what extent these results are possible.”

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
SYM TRADE IT LAST %CHG

Markets

DOW 17,841.98 -86.22 -0.48%
S&P 500 2,080.15 -9.31 -0.45%
NASDAQ 4,919.6440 -19.6830 -0.40%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs