Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

PROMUS Element Stent Demonstrates Excellent Long-Term Safety and Effectiveness in PLATINUM Small Vessel Study

May 18, 2012 By AxoGen, Inc.

NATICK, Mass./PRNewswire/ — Boston
Scientific Corporation announces two-year results from the PLATINUM
Small Vessel study, demonstrating excellent safety and effectiveness outcomes
for the 2.25 mm PROMUS Element™ Everolimus-Eluting Platinum Chromium (PtCr)
Stent System in treating de novo coronary lesions in small coronary
vessels.  Analysis of the data was presented today at the annual EuroPCR
Scientific Program in Paris.

“The PLATINUM Small Vessel data continue to demonstrate
very low revascularization rates, with no myocardial infarction or stent
thrombosis through two years of follow up in patients treated with the 2.25 mm
PROMUS Element Stent,” said Ian Meredith, Professor and Director of
MonashHeart, at Monash Medical Centre in Melbourne, Australia, and co-principal
investigator for the PLATINUM clinical program.  “These long-term
results are impressive, especially considering the small vessel diameters that
were evaluated in this study.”

The PLATINUM Small Vessel study previously met its primary
endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4 percent
for the 2.25 mm PROMUS Element Stent compared to a pre-specified performance
goal of 21.1 percent (p<0.001) based on historical outcomes for the 2.25 mm
TAXUS® Express® Paclitaxel-Eluting Stent.  The TLF rate at two years was
4.7 percent with the 2.25 mm PROMUS Element Stent while the rate of target
lesion revascularization (TLR) was 2.5 percent.  Rates of other major
adverse events remained low in patients treated with study stents at two years,
including cardiac death (2.3 percent), myocardial infarction (0.0 percent) and
Academic Research Consortium (ARC) definite/probable stent thrombosis (0.0
percent).  There were no deaths between 1 and 2 years for patients treated
with the 2.25 mm PROMUS Element Stent.

“The PLATINUM Small Vessel data build on the positive
long-term outcomes from the PLATINUM Workhorse trial, which reported excellent
safety and effectiveness of the PROMUS Element Stent in workhorse lesions and
demonstrated superior efficacy compared to the XIENCE V® (PROMUS®) Stent in a
landmark analysis of revascularization outcomes from year one to year
two,” said Keith D. Dawkins, M.D., global chief medical officer for Boston
Scientific.  “The results demonstrate a highly effective platinum
chromium small vessel stent platform with an excellent safety profile. 
This study of the 2.25 mm PROMUS Element Stent reconfirms our commitment to
providing a complete range of stenting solutions and sizes for physicians and
their patients.”

Boston Scientific received CE Mark approval for the PROMUS
Element Stent System in 2009 and for the PROMUS Element Plus Stent System in
2011.  In the U.S.,
the PROMUS Element Plus Stent System was approved by the Food and Drug
Administration in 2011.  The PROMUS Element Stent, part of the PROMUS
Element Stent System and the PROMUS Element Plus Stent System, employs a
proprietary PtCr alloy designed specifically for coronary stenting, which
enables enhanced visibility, less recoil, excellent conformability and higher
radial strength.  The PROMUS Element Plus Stent System employs an advanced
low-profile delivery system, designed to facilitate precise delivery of the
stent across challenging lesions.

XIENCE is a trademark of the Abbott Laboratories group of
companies.  PROMUS is a private-labeled XIENCE V everolimus-eluting stent
system manufactured by Abbott and distributed by Boston Scientific.

About the PLATINUM Small Vessel Study

The PLATINUM Small Vessel study is a prospective, multicenter, single-arm,
subtrial of the PLATINUM clinical program designed to evaluate the safety and
effectiveness of the PROMUS Element Stent (2.25 mm) for the treatment of de
novo coronary lesions in patients with small vessels (greater than or equal to
2.25 to <2.50 mm reference vessel diameter and less than or equal to 28 mm
lesion length). 

About Boston
Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical
devices that are used in a broad range of interventional medical specialties.
 For more information, please visit: www.bostonscientific.com.  

Related Articles Read More >

Prix Galien USA 2022 nominees
The 24 best medical device innovations of 2022
A portrait of Ellen Roche, MIT School of Engineering associate professor
New implant design prevents scar tissue without drugs, MIT says
UMN artificial blood vessel clinical trial
Minnesota researchers awarded $3.7M grant for artificial, bioengineered blood vessel clinical trial
CeQur Simplicity
CeQur is launching a discreet, convenient ‘wearable insulin pen’

DeviceTalks Weekly.

August 12, 2022
DTW – Medtronic’s Mauri brings years of patient care to top clinical, regulatory, scientific post
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • Subscribe to Print Magazine
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech