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:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Surface Marker Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/25/2015)... 25, 2015  The American Academy of Pediatrics ... and the March of Dimes cheered today,s signature ... Infants Act of 2015 (S.799), which takes ... born exposed to drugs, such as opioids, and ... all three organizations have worked together leading advocacy ...
(Date:11/25/2015)...  ARKRAY USA , Inc., a ... demonstrating the accuracy of its blood glucose meter systems. ... Diabetes and Cardiovascular Disease in Los Angeles ... ® 01 meter and the Assure ® ... to accurately measure glucose levels in blood is essential ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... There is only one major question facing all law firms ... This question has not been an easy question to answer. Especially when the senior ... younger workforce don’t share the same discipline around working long hours. , In ...
(Date:11/27/2015)... ... , ... A team of Swiss doctors has released a report on mesothelioma ... posted the findings on the website. Click here to read the details now. ... patients who were treated with chemotherapy followed by EPP surgery. Among the 106 patients ...
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion is ... Pro X. With ProSidebar: Fasion, video editors can easily add an informative sidebar ... minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and text ...
(Date:11/27/2015)... ... 27, 2015 , ... The moment you stop improving is ... fulfilling the needs of advisers and clients but going above and beyond to ... customer service. However, there's always room for improvement, which is why the entire ...
(Date:11/27/2015)... ... 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces his ... is one of Joplin's most famous and beautiful concert posters. The concert was held ... Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's stardom ...
Breaking Medicine News(10 mins):