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IDev Technologies, Inc. Announces Positive Two-Year Clinical Outcomes From Long Term Registry of the SUPERA® Stent in Femoropopliteal Artery Disease


10/11/2012 8:09:54 AM

LAS VEGAS and WEBSTER, Texas, Oct. 10, 2012 /PRNewswire/ -- IDEV Technologies, Inc. today announced positive two-year clinical outcomes of the SUPERA® Peripheral Stent System from SUPERA 500, a long-term registry which was presented at the 10th VIVA Conference held in Las Vegas, Nevada by principal investigator, Dierk Scheinert, M.D., Chairman for the Center of Vascular Medicine at Park Hospital and Heart Center in Leipzig, Germany.

"The SUPERA 500 registry reflects a real-world patient population," noted Dr. Scheinert. "The flexibility and durability of the SUPERA stent enabled these impressive long-term patency data across a broad range of disease, including difficult to treat areas historically considered 'no stent zones.' Given these results, SUPERA should now be considered a primary option for femoropopliteal arteries."

A total of 495 patients with 528 lesions were enrolled in the registry which included a very challenging patient population.

  • 51 percent of patients included had diabetes.
  • 53 percent of patients had occlusive femoropopliteal disease.
  • Mean stented segment length was 12.6 cm with approximately 69 percent being Rutherford Becker Class 3 or higher.
  • 13 percent of the patients had experienced tissue loss.
  • 53 percent of the treated lesions were classified as TASC D.

The primary endpoint of the SUPERA 500 Registry, patency at one and two years, respectively, was 84.1 percent and 73.0 percent. Additional patency results include:

Stented Segment Length

(mean)

1 year Patency

(mean)

2 year Patency

(mean)

< 70 mm (4.9 cm)

89.3 percent

77.8 percent

> 70mm and < 150 mm (10.3 cm)

82.2 percent

73.5 percent

> 150 mm (22.3 cm)

81.5 percent

67.9 percent

The SFA and popliteal arteries are exposed to significant mechanical stress with bending and rotation of the knee, and represent a harsh environment for any endovascular device. An ideal stent for use in these areas should offer a great range of motion without interrupting the anatomical function of the arteries.

"The new SUPERA 500 data, coupled with previously reported clinical findings including the SUPERB IDE Pivotal Trial results, establish a broad and highly consistent growing body of clinical evidence for SUPERA demonstrating superior outcomes for SFA-popliteal treatment," stated Christopher M. Owens, President and CEO of IDEV."

About the SUPERA Stent
The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in multiple other countries for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).

About IDEV Technologies, Inc.
IDEV is a developer of endovascular technologies designed to protect and restore anatomical function. The Company is focused on redefining the endovascular treatment paradigm by providing physicians and patients with a new standard of technologies that deliver clinical excellence. For more information, please visit www.idevmd.com.

SOURCE IDEV Technologies, Inc.



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