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:12/8/2016)... LITTLE FALLS, N.J., Dec. 8, 2016 CANTEL MEDICAL ... net income of $18,800,000, or $0.45 per diluted share, on ... the first quarter ended October 31, 2016. This compares with ... sales of $153,779,000 for the first quarter ended October 31, ... the first quarter ended October 31, 2016 to $21,323,000, or ...
(Date:12/8/2016)... , Dec. 8, 2016   Mederi Therapeutics Inc . has announced regulatory approval ... a non-surgical treatment for chronic gastroesophageal reflux disease (GERD). ... ... broadcast during the Chinese Congress of Digestive Endoscopy, by Professor Jun Liu, Director of ... , , "We are very pleased ...
(Date:12/8/2016)... and SAN DIEGO , Dec. 8, 2016 ... solutions with cutting edge next-generation sequencing and bioinformatics expertise; AITbiotech ... and the Genome Institute of Singapore ... new joint venture between Novogene and AITbiotech – will establish ... Singapore .   The new centre ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... ... STAT courier is pleased to announce that due to customer demand, as ... their presence in Dallas. One of the most exciting parts for STAT is that ... Dallas and Forth Worth market. STAT takes pride in treating their employees with integrity ...
(Date:12/8/2016)... ... December 08, 2016 , ... Dickinson Insurance ... offices headquartered in Little Rock, has initiated a charity drive to provide support ... Foundation to End Senior Hunger, Arkansas ranks first in senior hunger statewide, third ...
(Date:12/8/2016)... ... December 08, 2016 , ... The Compretta Insurance Agency, ... residential clients in and around the Hancock County area, is announcing the launch of ... Food Pantry. , The Hancock County Food Pantry has worked for more than 30 ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... of the most comprehensive mental health systems reform legislation in more than fifty ... President, and the commitment of our elected officials to improving mental health services ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... up with a schizophrenic mother in a unique, personal perspective through animation. ... treating trauma and addictive disorders at her private psychotherapy practice. Sheri’s mother, Pearl, ...
Breaking Medicine News(10 mins):