CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices

Article preview from "The Gray Sheet"-  April 16, 2012

Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.

CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices

Article preview from "The Gray Sheet"-  April 16, 2012

Device companies are getting a first chance to participate in CDRH’s innovation pathway pilot focused on early, hyper-collaboration between sponsors and reviewers under a new stage of the program announced April 9.

FDA has selected three investigational-stage devices for end-stage renal disease as part of its innovation pathway 2.0 program.

Two of the devices are being developed by start-up device firms — a wearable artificial kidney by Blood Purification Technologies and a hemoaccess valve system from CreatiVasc Medical. A third product is still in the hands of an academic institution, an implantable renal assist device in development at the University of California, San Francisco.

CreatiVasc Medical's hemoaccess valve system opens and closes the graft-created connection between the vein and artery in patients on hemodialysis to prevent blood clots.

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