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United States. Food and Drug Administration

Endologix Receives FDA Approval for Clinical Trial of Powerlink System

Strategic Insights

— 1 min read

Endologix, Inc., a company specializing in minimally invasive treatments for vascular diseases, has received approval from the U.S. Food and Drug Administration (FDA) to enroll patients in a clinical trial utilizing the Powerlink System to treat abdominal aortic aneurysm (AAA) in patients with large diameter aortic necks. The Powerlink System, if approved for marketing in the United States, would be the only endoluminal stent graft (ELG) for use in AAA patients with aneurysm neck diameters up to 32 mm. The FDA's approval will allow Endologix to study alternative implant strategies to treat a subset of patients who cannot be treated with an FDA-approved ELG. Paul McCormick, Endologix's president and chief executive officer, stated that the company's Powerlink System was designed with multiple main body lengths and diameters to improve its adaptability to variations in patient anatomies.

Key Takeaways:

  • The Powerlink System, if approved, would be the only endoluminal stent graft (ELG) for use in AAA patients with aneurysm neck diameters up to 32 mm.
  • Approximately 5-10% of AAA patients evaluated for minimally invasive treatment are excluded due to a large aortic neck diameter.
  • Three ELG devices, including the Powerlink System, are currently FDA-approved to treat aortic necks up to 26 mm in diameter, and one additional ELG is FDA-approved to treat necks up to 28 mm in diameter.
  • Endologix expects to begin enrollment in both studies in the current quarter.
  • The company's Powerlink System was designed with multiple main body lengths and diameters to improve its adaptability to variations in patient anatomies.
  • The company received approval to initiate a 7-center, 60-patient protocol utilizing a large-diameter infrarenal cuff with its approved Powerlink bifurcated device.

Statistics:

  • 5-10% of AAA patients evaluated for minimally invasive treatment are excluded due to a large aortic neck diameter.
  • The Powerlink System is designed to treat aortic neck diameters up to 32 mm.
  • Three ELG devices, including the Powerlink System, are currently FDA-approved to treat aortic necks up to 26 mm in diameter.
  • One additional ELG is FDA-approved to treat aortic necks up to 28 mm in diameter.
  • 7 centers will participate in the clinical trial utilizing a large-diameter infrarenal cuff with the Powerlink bifurcated device.
  • 60 patients will be enrolled in the clinical trial.

Sources:

  • Science Letter editors, "Endologix Receives FDA Approval for Clinical Trial of Powerlink System," NewsRx.com, 2005.
  • Endologix, Inc., "Powerlink System," Endologix.com.

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