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FDA permits marketing of first catheter-based systems for vascular access for patients on hemodialysis
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The FDA has granted marketing authorization for the use of the Ellipsys Vascular Access System and the everlinQ endoAVF System to make percutaneous arteriovenous fistulas for patients with CKD who are on hemodialysis.
A catheter is inserted into a blood vessel in the arm and is guided to the site of the planned arteriovenous (AV) fistula. The devices then deliver energy to form a connection between an upper forearm artery and an adjacent vein. The Ellipsys Vascular Access System, which will be marketed by Avenu Medical, uses one catheter. The everlinQ endoAVF System, which will be marketed by TVA Medical Inc., uses two catheters.
For the Ellipsys Vascular Access System, the FDA reviewed data from a non-randomized, multicenter study of 103 patients. The Ellipsys Vascular Access System was used in a procedure to create an AV fistula, of which 92 patients met the criteria for a usable AV fistula within 3 months after the procedure. Overall, 96.1% of patients required an additional procedure in the first 12 months to maintain the fistula.
For the everlinQ endoAVF System, the FDA reviewed data from a non-randomized, multicenter study of 60 patients, in addition to supporting data from three other studies and clinical use of the device outside the United States. The everlinQ endoAVF System was used in a procedure to create an AV fistula in these patients. In the main study, 52 patients met the criteria for a usable AV fistula within 3 months after the procedure. Overall, 96.7% of patients required an additional procedure at the time the fistula was created, while 28.3% of patients required an additional procedure in the first 12 months to maintain the fistula.
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