Navigation Links
IDEV Technologies Announces Completion of SUPERB Clinical Trial Enrollment
Date:6/2/2011

WEBSTER, Texas, June 2, 2011 /PRNewswire/ -- IDEV Technologies, Inc. (IDEV) today announced the completion of enrollment in the SUPERB Trial, an FDA-approved IDE trial evaluating the use of IDEV's SUPERA® stent system for treatment of peripheral artery disease in the superficial femoral artery (SFA).  Enrollment was completed in May, making SUPERB one of the fastest enrolling SFA trials.

The trial is a prospective, single-arm study of 258 patients at 49 U.S. sites, led by national co-investigators Kenneth Rosenfield, M.D., of Massachusetts General Hospital in Boston and Lawrence Garcia, M.D., of Steward's St. Elizabeth's Medical Center of Boston.  The study objective is to demonstrate safety and effectiveness of the SUPERA stent in treating obstructive disease in the SFA.

Dr. Rosenfield summarized, "We are excited to complete enrollment in this important trial, and will now focus our efforts on patient follow-up and analysis.  Given the encouraging data we've seen from Europe for the SUPERA stent, and given the stent's outstanding mechanical properties, we are anxious to finalize our results. It has been a pleasure to work with the great team of researchers, coordinators, and support staff on this trial."

"Endovascular treatment of the SFA in particular has been problematic for the millions of patients suffering from PAD in the United States," added Dr. Garcia.  "The unique radial strength and flexibility of the SUPERA stent's design may provide what has been needed to successfully treat this challenging vessel."

Dennis Donohoe, M.D., is IDEV's Chief Medical Officer and has served as a key liaison to the clinical site investigators throughout the trial.  "Completing enrollment of more than 250 pivotal patients in less than two years is a significant achievement and reflects not only the caliber of our investigator teams but also their confidence in this stent.  I congratulate the team and look forward to our continued collaboration."

"Completing enrollment in the SUPERB trial is a significant milestone, and reflects IDEV's ongoing commitment to clinical research," remarked IDEV's President and Chief Executive Officer Christopher M. Owens.

The SUPERA VERITAS Transhepatic Biliary System currently has 510(k) clearance in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms.  The SUPERB trial results will be used to support IDEV's pre-market approval (PMA) submission for an additional peripheral vascular indication.

About IDEV Technologies, IncorporatedIDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in interventional radiology, vascular surgery and cardiology.  IDEV's worldwide headquarters is located in Webster, Texas and its European headquarters is located in Beuningen, The Netherlands.

The SUPERB Trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) is an FDA-approved IDE trial to evaluate SUPERA in treating patients with obstructive superficial femoral artery (SFA) disease.

The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada and Australia for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).

For more information please visit www.idevmd.com. Contact:

Donna LucchesiVice President Global MarketingIDEV Technologies, Incorporated(281) 525-2000
'/>"/>

SOURCE IDEV Technologies, Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. China Medical Technologies Reports Fourth Fiscal Quarter and Full Fiscal Year Financial Results
2. Luminex and Life Technologies Sign Agreement for Global Distribution of the Award-Winning MAGPIX® Multiplexing Instrument
3. Caliper Owners Group Meeting Showcases Transformative Technologies for Advancing Personalized Medicine
4. Medical Magnetic Resonance Imaging (MRI): Technologies and Global Markets
5. Genetic Technologies Processes First BREVAGen™ Patient Sample
6. MultiCell Technologies is Granted Stem Cell Patent
7. TriLink BioTechnologies, Inc. Awarded European Patent for CleanAmp™ Primers
8. Vicor Technologies CEO David H. Fater to Present Live, Online at RetailInvestorConferences.com
9. Mind Technologies Inc. Developing Revolutionary EEG Brain Computer Interface
10. Patient Safety Technologies Reports First Quarter 2011 Results
11. BioSpecifics Technologies Corp. Provides Update on XIAPEX® Launch Progress in EU
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... Eyevensys, a private biotechnology company ... expression technology that enables the safe, local, sustained production ... wide range of ophthalmic diseases, announces it has received ... Agency (MHRA) to advance its technology into clinical development. ... The EyeCET ...
(Date:4/19/2017)... , April 19, 2017 The Mobile X-Ray ... showcase a healthy CAGR during the forecast period ... in the global digital mobile X-Ray devices market, which is ... in 2017, expanding at a CAGR of 7% over the ... $ opportunity of more than US$ 100 Mn in 2017 ...
(Date:4/19/2017)... The Global Effective Microorganisms (EM) Market ... has covered and analysed the potential of Global Effective Microorganisms ... shares and growth factors. The report identifies and analyses the ... the global market. ... 152 Tables and Figures, 6 Major Company Profiles, spread across ...
Breaking Medicine Technology:
(Date:4/25/2017)... VIRGINIA (PRWEB) , ... April 25, 2017 , ... ... leading the way in unveiling cutting-edge birth defects research related to Zika virus ... by the world’s premier society for this important science. , The ...
(Date:4/25/2017)... (PRWEB) , ... April 25, 2017 , ... Buyers and ... recreational users to dispensaries and head shops –can’t help but be heartened by the ... the tell-tale cannabis odor aptly described as “skunk smell.” At last they can ...
(Date:4/25/2017)... ... April 25, 2017 , ... Somnoware, a leading ... patient care management module. Using this new feature, sleep physicians can now predict ... on continuous positive airway pressure (CPAP), oral, or other forms of sleep apnea ...
(Date:4/25/2017)... ... , ... There is no better place in South Florida to undergo two ... May issue of Consumer Reports focused on heart health. , The magazine gave ... after coronary bypass and aortic valve replacement procedures. , Consumer Reports rated ...
(Date:4/25/2017)... ... April 25, 2017 , ... Amendia, ... continuation of its strategic partnership with and platinum sponsorship of Global Spine Outreach ... safe and effective management of complex spine deformity cases, particularly in children. , ...
Breaking Medicine News(10 mins):