FDA Clears Clears Catheter Based Hemodialysis Vascular Access Systems

Two hemodialysis devices the Ellipsys Vascular Access System and everlinQ endoAVF System have secured FDA clearances. Details of the devices and data on them different but overall the products use similar technology to address the same medical need centering on how kidney failure patients are prepared for hemodialysis. To perform the blood cleansing process healthcare professionals need a route for the blood to move in and out of the body, access route can be enabled by AV fistula which is a surgical connection between an artery and vein in the arm, once healed it can receive 2 needles to facilitate hemodialysis. Successful AV fistulas have been shown to outperform other access methods against multiple patient and financial outcomes, however a significant proportion of fistulas do not mature to the point of being ready for hemodialysis use.

Avenu Medical and TVA Medical developed these devices to help save time, money, and patient burden in creation of access route points. The devices feature catheters that physicians guide along a blood vessel in the arm to the planned site of AV fistula, at that site the devices release energy to connect an artery to a vein creating a fistula.

In clinical trials upwards of 95% of people treated using the devices had usable AV fistulas within three months, with additional procedures commonly being required such as balloon angioplasty. Ellipsys trials showed 96.1% of patients required another procedure within the first 12 months. EverlinQ trails showed 28.3% with 96.7% of participants requiring additional procedures when the fistula was created.

Now that 510(k) FDA clearance has been secured producing companies can turn their attention towards commercialization, like all device makers they will need to secure payer coverage, and face the challenge of getting the healthcare system to embrace a different approach to creating AV fistulas.