Navigation Links
IDEV Technologies Announces FDA 510(k) Clearance for SUPERA VERITAS™
Date:11/3/2010

WEBSTER, Texas, Nov. 3, 2010 /PRNewswire/ -- IDEV Technologies, Incorporated (IDEV), an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the SUPERA VERITAS Transhepatic Biliary System.

SUPERA VERITAS is the next-generation delivery system for IDEV's unique SUPERA® wire interwoven nitinol stent, currently cleared in the U.S. for palliative treatment of biliary strictures produced by malignant neoplasms.  The SUPERA VERITAS system is also approved for use in the ongoing FDA-approved IDE trial in the U.S. for treatment of peripheral arterial disease of the superficial femoral artery (SFA).  The FDA 510(k) clearance notification was dated October 5, 2010.

"Clearance of the SUPERA VERITAS system represents the culmination of a strong effort to respond to customer needs," explained Christopher M. Owens, President and CEO of IDEV.  "The result is an innovative system that we believe provides us with a significant competitive advantage, and may represent a paradigm shift in how patients are treated."

The new device provides easier deployment of the Supera stent compared to earlier systems, eliminating multiple steps previously required for preparation and delivery.  More importantly, the new system allows operators to place the stent more precisely than before.

"I've been deploying the SUPERA stent now for over a year.  The high radial force of the stent is particularly suited for biliary strictures.  The introduction of the SUPERA VERITAS system is a great complement to an outstanding stent," stated Mark Garcia, MD, Chief of Interventional Radiology at Christiana Care Health System in Wilmington, Delaware.

Gino Sedillo, MD, FACC of Bradenton Cardiology Center in Bradenton, Florida, is an investigator in the SFA trial.  He commented, "I've seen the SUPERA VERITAS system demonstrated, and was able to use it myself during a visit to Park Hospital in Leipzig, Germany.  The delivery steps have not only been greatly simplified, but there is also improved reliability and predictability of stent placement.  I look forward to incorporating the new delivery system into the ongoing prospective trial."

Don Jacobs, MD, a vascular surgeon at St. Louis University Hospital in St. Louis, Missouri, was asked to provide feedback on the new delivery system while in Leipzig, Germany and stated, "I was very impressed with the accuracy of the VERITAS system, and appreciated how it improved the ease of delivery of the SUPERA stent.
It represents a truly significant advance and adds significantly to an outstanding product package."

Commercial availability of the SUPERA VERITAS Transhepatic Biliary System is planned for the first quarter of 2011.

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.  Please visit www.idevmd.com.

The SUPERA stent is currently indicated in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).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. Patient Safety Technologies Appoints New Chief Financial Officer
2. Over 20 New Clinical Studies Presented on Masimo Noninvasive Patient Monitoring Technologies at the American Society of Anesthesiologists Annual Meeting
3. Frost & Sullivan Award Highlights Hybridyne Technologies Outstanding Technology Innovation
4. CareFusion Selects Palomar Pomerado Health as Development Partner for Patient Safety Technologies
5. China Medical Technologies Announces its Subsidiary, GP Medical, Ranked Sixth in Deloitte Technology Fast 50 China 2010 Program
6. IDEV Technologies Launches Additional Products in Europe
7. Althea Technologies Announces the Installation of a High-Speed Prefilled Syringe Line
8. Visonic Technologies Announces the Immediate Availability of its Elpas Door Kit, an All-in-One Starter Kit Packaged With Everything Required to Install a Single-Door Wandering Patient and Resident Protection Solution
9. BioSpecifics Technologies Corp. to Present at BioCentury Newsmakers in the Biotech Industry Conference
10. Medical Device Industry Executive Joins OrthoAccel Technologies, Inc. Board of Directors
11. Netsmart Technologies is First Behavioral Healthcare Software Provider to Pass Final Rule ARRA Certification Tests
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
(Date:6/24/2016)... Calif. , June 24, 2016  American Respiratory Labs (ARL), ... is now able to perform sophisticated lung assessments in patients, homes, ... , Inc. Patients are no longer limited to ... EasyOne PRO ® , ARL patients like Jeanne R. of ... in the comfort of her own home. ...
Breaking Medicine Technology:
(Date:6/26/2016)... Cary, North Carolina (PRWEB) , ... June 26, 2016 , ... ... the release of a new product that was developed to enhance the health of ... harvested for centuries. , The two main herbs in the PawPaws Cat Kidney ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
Breaking Medicine News(10 mins):