Navigation Links
IDEV(R) Technologies Announces First Patient Enrolled in Multi-Center Clinical Trial of SUPERA(R) PERipheral Stent

HOUSTON, Aug. 24 /PRNewswire/ -- IDEV(R) Technologies, Incorporated, (IDEV) an emerging leader in the development and marketing of minimally invasive medical technologies, today announced that the first patient was enrolled in the Company's FDA-approved multi-center clinical trial of its self-expanding SUPERA(R) stent, a novel stent platform designed for the treatment of biliary and peripheral artery disease (PAD) in the superficial femoral artery (SFA). PAD of the lower extremities affects approximately 8 million-12 million people in the U.S. alone, according to the American Heart Association.

The clinical trial, called SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery), is a prospective, single-arm trial of 258 patients at up to 40 U.S. sites. It is led by national co-principal investigators Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, and Lawrence A. Garcia, M.D. Chief, Section Interventional Cardiology and Associate Director of Vascular Medicine at Boston's Caritas St. Elizabeth Medical Center, where the first patient was treated.

The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. The SUPERA Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary system received 510(k) clearance for palliative treatment of biliary strictures produced by malignant neoplasms and the SUPERA Interwoven Self-Expanding Nitinol Stent System received CE Mark approval in Europe for biliary and peripheral vascular indications.

"The SUPERA stent has unique properties that may be demonstrated on patients at facilities throughout the U.S.," Dr. Rosenfield said. "We believe this could prove to offer a significant advance in treating PAD and helping physicians treat the most difficult of blockages in a very large underserved patient population."

Dr. Garcia added, "Ultimately, through this study, the SUPERA stent could become the new benchmark for stenting infra-inguinal femoral arterial obstructive disease."

Peter Soukas, M.D., Director of Vascular Medicine and the Vascular Laboratories at St. Elizabeth's, enrolled and treated the trial's first patient.

"Our patient had a calcified SFA lesion that was treated thanks to the radial strength and flexibility afforded by the unique woven design of the SUPERA stent," Dr. Soukas said. "I am confident the stent will demonstrate the same resistance to strut fracture and primary patency that has been seen in Europe."

IDEV President and Chief Operating Officer Christopher M. Owens called the enrollment of the first patient "a significant milestone for IDEV Technologies and an opportunity to demonstrate the safety and effectiveness of the unique SUPERA design. I'd like to congratulate all the members of our team on our progress to this point."

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:  Christopher M. Owens, President and COO
              John Dame, Vice President of Finance
              IDEV Technologies, Inc.
              (281) 333-1998

SOURCE IDEV Technologies, Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
2. King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program With Bremelanotide for Erectile Dysfunction
3. Rockwell Medical Technologies, Inc. Begins Patient Enrollment for its SFP Dose-Ranging Study
4. Rockwell Medical Technologies, Inc. Begins Dosing Patients for SFP Phase IIb Clinical Study
5. New Clinical Studies Confirm Mauna Kea Technologies Cellvizio(R) GI in Range of Procedures
6. Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure
7. Emisphere Technologies, Inc. Announces 2007 Third Quarter Financial Results
8. Senesco Technologies Initiates Preclinical Studies for Cancer Target
9. ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G(R), a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer
10. Epeius Biotechnologies Applauds the Belated Scholarship of Their Academic Contemporaries in 2007, As Targeted Gene Therapy Comes of Age in Clinical Medicine
11. TCS Healthcare Technologies Releases Three New Clinical Care Programs Within ACUITY
Post Your Comments:
(Date:9/27/2017)... Sept. 27, 2017  Commended for their devotion to personalized ... Ranked as number one in the South Florida Business Journal,s ... Inc. 5000 yearly list, the national specialty pharmacy has found ... Bardisa will soon be honored by SFBJ as the ... Set to receive his award in October, Bardisa ...
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term ... long-term care insurance companies have a waiver for care if the client has a ... when the family pays for care, is often waived, so the benefits from their ...
(Date:10/13/2017)... ... ... Ellevate Network, the leading network for professional women, brought together some of ... their inaugural Summit in New York City in June. The event was livestreamed with ... 3 million. To watch the Mobilize Women video, click here . , ...
(Date:10/13/2017)... ... 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of ... popular and least understood books in the Holy Scriptures, Revelation. The Book of Revelation ... scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
Breaking Medicine News(10 mins):