U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent
Created by News on 3/18/2009 12:16:21 PM

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).


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
print
The comment feature is locked by administrator.
Search News
Top Stories

Apr24 Dental Health Products, Inc. (DHPI) Announces Strategic Alliance with the Dental Exchange
Created by Admin on 4/24/2015 9:24:38 AM

 Dental Health Products, Inc. (DHPI) and The Dental Exchange have announced the formation of a ne...
Read More..

Mar12 Dr. Richard Hughes Named an Honored Fellow of the American Academy of Implant Dentistry
Created by udent webmaster on 3/12/2015 11:04:13 AM

The American Academy of Implant Dentistry (AAID) has named Dr. Richard Hughes an Honored Fellow due ...
Read More..

Mar12 Deerfield Delivers Superior Veterinary Dentistry with Elite Drill
Created by udent webmaster on 3/12/2015 10:41:57 AM

One of Springfield’s leading animal hospitals continues its commitment to providing the best in vete...
Read More..

Mar12 Studio B Dental Launches New Website Specifically for Their All on 4 Dental Implant Procedure
Created by udent webmaster on 3/12/2015 10:39:47 AM

The new website launched by the popular Toronto dental clinic offers a simple 2 minute assessment fo...
Read More..

Mar09 Dr. E. Dale Behner Gives Indianapolis, IN Residents Access to a Minimally Invasive Receding Gums Treatment
Created by udent webmaster on 3/9/2015 10:09:50 PM

Dr. E. Dale Behner of Dental Care Today, PC is expanding his practice to offer help to those with re...
Read More..

Mar09 Growing Emphasis on Prevention of Caries Drives the Global Dental Preventive Supplies Market, According to a New Report by Global Industry Analysts, Inc
Created by udent webmaster on 3/9/2015 10:06:00 PM

Dental caries or tooth decay is one of the major issues for public healthcare systems in most countr...
Read More..

Mar07 Dr. John Schiro DDS Opens New Cosmetic Dentistry Practice in Austin, Texas
Created by udent webmaster on 3/7/2015 4:10:59 PM

Dr. John Schiro DDS is now announcing the grand opening of his new cosmetic dentistry practice in A...
Read More..

Mar20 One Third of Americans Still in Need of Affordable Dental Care Options
Created by Melissa Watkins on 3/20/2014 11:46:00 AM

According to Healthcare.gov, the Health and Human Services arm that is in charge of the federal heal...
Read More..

Feb11 DENTALPLANS.COM CREATES ONLINE PROJECT CENTER FOR NATIONAL CHILDREN’S DENTAL HEALTH MONTH
Created by Melissa Watkins on 2/11/2014 12:50:00 PM

 etting children to brush and floss every day isn’t always easy, especially when parents have a mil...
Read More..

Feb10 126.7 MILLION AMERICANS IN NEED OF DENTAL CARE OPTIONS
Created by Melissa Watkins on 2/10/2014 11:13:00 AM

 As the Affordable Care Act (ACA) discussion switches from accessing the federal and state health e...
Read More..

Jan21 DENTALPLANS.COM APPOINTS BOB HARRIS CHIEF EXECUTIVE OFFICER
Created by Melissa Watkins on 1/21/2014 3:39:00 PM

 entalPlans.com, a leading provider of dental savings plans, has named Bob Harris as chief executiv...
Read More..

Oct16 Keep Your Teeth White !
Created by Mint Cosmetics Review on 10/16/2013 11:58:00 PM

Great plastic is a teeth bleaching package which is prescribed by simply the majority of the dental ...
Read More..

Aug01 Gummy Smiles: What Are My Treatment Options?
Created by mapleavenuefamilydentistry on 8/1/2013 6:29:00 AM

When most people smile, you see a row of teeth that look beautiful and full. Unfortunately, this is ...
Read More..

Jul27 Plastic Surgeons Nj – A Smart Gateway To Beautification
Created by Dr. Michael A. Fiorillo, MD on 7/27/2013 12:05:00 AM

Plastic Surgeons Nj are veterans in the field of plastic surgery. These surgeons can completely cha...
Read More..

Jul22 Dental Implants: Evidence of Modern Dentistry
Created by paul589649 on 7/22/2013 4:50:00 AM

You can find out more about -   Dentist West Hartford CT , Dental Implants West Haven CT , De...
Read More..

Oct22 Guidance of Taking Good Care Of Braces
Created by bonniemendes on 10/22/2012 11:50:00 PM

 Guidance of Taking Good Care Of Braces Finding dependable techniques for taking care of braces as ...
Read More..

Aug13 Periodontist Comments On New Study Examining Diabetes Drug That May Be Able To Fight Oral Cancer
Created by Dr. Alex Farnoosh on 8/13/2012 12:24:00 PM

About The Total Smile: The Total Smile was founded by Beverly Hills Periodontist Dr. Alex Farn...
Read More..

Jul17 360imaging releases an improved version 4 of 360DPS dental implant planning software
Created by Manal on 7/17/2012 4:25:00 AM

 360 Imaging – an industry leader in dental implant planning - recently announced the release of  v...
Read More..

Jul11 iCare Financial Launches Strategic Alliance With Concorde Communications To Benefit Growth Of Dental Practices
Created by iCare Credit on 7/11/2012 4:28:00 PM

iCare Financial, a leading provider of patient credit, and Concorde Communications, an acclaimed me...
Read More..

Jun26 Periodontist Discusses Study Linking Osteoporosis Drug Complications To Patients With Certain Genes
Created by Dr. Alex Farnoosh on 6/26/2012 10:14:00 AM

On the heels of an earlier study linking antiresorptive drugs to medication induced osteonecrosis...
Read More..