November 14, 2024

Healionics’ Stargraft AV Dialysis Access Device Receives FDA Breakthrough Device Designation

November 14, 2024—Healionics Corporation announced that its Stargraft arteriovenous (AV) graft for dialysis access has been granted Breakthrough Device designation by the FDA. The company stated that Stargraft is designed to provide a safe and reliable means of bloodstream access for kidney failure patients needing dialysis.

According to the company, which is headquartered in Seattle, Washington, the Breakthrough Device designation signifies FDA acknowledgment that Stargraft clinical outcomes show evidence of significant advantages over existing alternatives for dialysis access.

The Stargraft device is based on Healionics’ synthetic biomaterial technology and is designed to resist the problems of occlusion and/or infection frequently seen in existing AV vascular grafts, stated Healionics.

Stargraft is an investigational device not yet available for commercial sale, advised the company.

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November 14, 2024

Healionics’ Stargraft AV Dialysis Access Device Receives FDA Breakthrough Device Designation

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