Navigation Links
U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent
Date:3/18/2009

Novel Stent Platform Designed for Radial Strength, Flexibility

HOUSTON, March 18 /PRNewswire/ -- IDEV Technologies Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive technologies, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a multi-center clinical trial of its SUPERA stent, a novel stent platform designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). PAD affects more than 8 million people in the U.S. alone and, by the age of 65, 12-20 percent of the population will develop PAD, according to the American Heart Association.

The SUPERB trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery), a prospective, single-arm trial of 258 subjects at up to 40 U.S. sites, will be led by national co-principal investigators Kenneth Rosenfield, M.D., of Massachusetts General Hospital, Boston, MA and Lawrence Garcia, M.D., of Caritas St. Elizabeth's Medical Center, Boston, MA.

"The approval of this IDE marks a significant step forward toward understanding the potential benefits of the unique properties of the SUPERA stent," Dr. Rosenfeld said. "Members of the physician community have already shown a high level of interest in this novel stent platform and IDEV's commitment to generating prospective clinical data will help us demonstrate the promise of this device."

The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA Interwoven Self-Expanding Nitinol Stent in treating subjects with obstructive SFA disease. SUPERA has demonstrated superior properties in engineering tests compared to nitinol laser cut slotted tube stents resulting in greater than four times the radial strength and 360 percent stronger crush resistance. The unprecedented increase in radial strength is due to the product's novel interwoven design, which adds strength without compromising flexibility. SUPERA also withstood more than 10,000,000 cycles of repeated bending - 120 degree flexion and compression loading fatigue testing, without a fracture.

"We believe SUPERA may prove to be a more durable solution and ultimately the gold standard for the treatment of PAD, a serious condition for millions of Americans and others around the world," said Tom Tully, Chairman and CEO of IDEV Technologies. "We are excited to begin enrolling subjects into the SUPERB trial and look forward to compiling data that will demonstrate the effectiveness of its unique design."

About IDEV Technologies, Incorporated

IDEV Technologies, Incorporated (IDEV) is an innovator and developer of next generation medical devices for use in the interventional radiology, vascular surgery and cardiology device marketplace. IDEV is based in Houston, Texas.

    Contact:  Thomas M. Tully, Chairman and CEO
              Christopher M. Owens, President and COO
              John Dame, Director of Finance
              IDEV Technologies Inc.
              (281) 333-1998


'/>"/>
SOURCE IDEV Technologies, Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
2. Rendell Administration Announces Health Research Grants From Tobacco Settlement Funds
3. ISTA Pharmaceuticals New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
4. ImQuest Submits Investigational New Product Application to the Food and Drug Administration to Initiate HIV Therapeutic Clinical Trials with IQP-0410
5. Oramed Pharmaceuticals Chosen to Present Results of GLP-1 Analog Enteral Administration Study at the Diabetes Technology Societys Eighth Annual Meeting (November 13-15, 2008; Bethesda, Maryland)
6. Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
7. New AAHC Toolkit Available to Optimize Clinical Research Administration
8. New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
9. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
10. Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study
11. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... 23, 2017   Icertis , the leading ... the cloud, today announced an upgrade to the ... to improve clinical trials contract management. Built on ... the solution speeds up clinical trial contracting while ... (CRO). "The pharmaceutical industry is ...
(Date:3/23/2017)... March 23, 2017 A research report ... is expected to reach USD 7.2 billion by the end ... preparation is a procedure in which a sample is preserved ... most analytical procedures since the methods are often allowing repeated ... of the most shared procedures in the lab. In many ...
(Date:3/23/2017)... , March 23, 2017 Ascendis Pharma A/S ... TransCon technology to address significant unmet medical needs in ... a conference call and webcast on Monday, April 3 ... Society in Orlando, Florida , to ... candidates (TransCon Growth Hormone, TransCon PTH and TransCon CNP). ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... ... families and businesses of the Norwalk and Vermillion areas, celebrates the newest ... (N.O.R.A.) is a nonprofit, community-based substance abuse prevention and peer recovery support ...
(Date:3/23/2017)... ... March 23, 2017 , ... Benefits delivery trailblazer, Hodges-Mace, ... and centralized benefits dashboard solving one of the top frustrations in employee benefits ... the first time, employees can access up-to-date information and account balances for all ...
(Date:3/23/2017)... ... March 23, 2017 , ... Hakim Unique Group ... technology company California Healthcom Group (CHG). , The HUG investment is a ... headquarters in California, CHG is a growing, internationally recognized healthcare management, technology, and ...
(Date:3/23/2017)... Scottsdale, AZ (PRWEB) , ... March 23, 2017 , ... ... helping people around the world to manage stress and anxiety. , “Buzzies change ... Serin, neuropsychologist, inventor and co-founder of Buzzies. , Since its launch date in December ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... a new solution that enables organizations to easily reprint customer invoices, bills, statements ... Server’ automates all of the steps needed to retrieve and print the documents ...
Breaking Medicine News(10 mins):