Medtronic to acquire Avenu Medical and its outpatient procedure for creating dialysis fistulas

Medtronic has moved to acquire Avenu Medical, developers of a minimally invasive method of building the blood vessel access ports used by patients receiving dialysis treatments.

Typically, patients with end-stage renal disease and kidney failure undergo an open surgical procedure to create an arteriovenous fistulae—a connection that bridges an artery and vein in the arm that becomes strong enough to withstand the fluid pressures that come with hemodialysis.

Avenu Medical’s Ellipsys vascular access system instead uses a single, ultrasound-guided catheter that fuses the two blood vessels together from within, creating a channel from inside the arm’s radial artery.

The two companies say the outpatient procedure can be performed quickly within a surgical center or a doctor’s office, and the device has received a CE Mark and was cleared by the FDA in 2018. In addition, the Ellipsys device offers faster healing and maturation of the fistula, allowing patients to access dialysis treatments faster compared to open procedures.

The financial terms of the deal—expected to close next month—were not disclosed.

“Until recently, the only option to create a fistula was through invasive surgery, which is associated with high failure rates," said Avenu co-founder Jeffrey Hull, who also serves as director of the Richmond Vascular Center. 

"The Ellipsys system has shown durable outcomes out to two years and has the ability to shorten procedure times and potentially reduce costs,” Hull said. “Unlike open surgery, sutures are not required after the procedure and the patient leaves with just an adhesive bandage."

RELATED: Medtronic's drug-coated balloon for dialysis fistulas clears study

The tuck-in deal builds upon Medtronic’s advances in the space over the past year, including the November 2019 FDA approval and subsequent commercial launch of its IN.PACT AV drug-coated balloon catheter, designed to reopen and clear collapsed fistulas—as well as the recent publication of its performance in the New England Journal of Medicine. 

"Now with the acquisition of Avenu Medical, we can support procedures across the vascular access care continuum, while continuing to provide innovative endovascular therapies that will ultimately reach even more patients with [end-stage renal disease] around the world,” said Mark Pacyna, vice president and general manager of Medtronic’s peripheral vascular business.