Avenu's percutaneous fistula creation technology is expected to strengthen Medtronic’s portfolio of peripheral vascular access products for ESRD treatment


Medtronic agrees to acquire Avenu Medical. (Credit: Medtronic)

Medtronic has agreed to acquire Avenu Medical, a California-based medical device maker developing fistula creation technology, for an undisclosed amount.

Avenu Medical is engaged in creating minimally invasive (endovascular) arteriovenous (AV) fistulae in end-stage renal disease (ESRD) patients undergoing dialysis.

AV fistula is a connection established between an artery and a vein, created on the patient’s arm using an open surgical procedure to facilitate the dialysis treatment.

Avenu Medical has developed the Ellipsys Vascular Access System, a single-catheter ultrasound-guided device that percutaneously inserts a catheter into the patient’s arm to create a long-lasting AV fistula.

Avenu Medical co-founder Jeffrey Hull said: “AV fistulae are like lifelines to patients undergoing dialysis. Until recently, the only option to create a fistula was through invasive surgery, which is associated with high failure rates.

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

Avenu Medical’s Ellipsys System granted CE Mark in EU and FDA approval in US

Procedure using the Ellipsys system can be performed in the hospital outpatient department, ambulatory surgery center (ASC), or physician’s office.

The Ellipsys Vascular Access System has been granted the CE Mark for commercialisation in the European Union (EU) and was approved by the US Food and Drug Administration.

The system is indicated in both EU and US for the creation of a proximal radial artery to perforating vein anastomosis for percutaneous creation of an AV fistula.

The Avenu Medical transaction is the sixth acquisition that Medtronic has made in 2020.

The transaction is planned to be completed in October 2020, subject to the satisfaction of certain customary closing conditions.

Medtronic peripheral vascular business vice president and general manager Mark Pacyna said: “Within the last year, we’ve seen significant momentum with the launch of the IN.PACT AV drug coated balloon (DCB) in the United States and primary endpoint results of the IN.PACT AV Access study being published 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 ESRD around the world.”

In August, Medtronic has agreed to acquire smart insulin pen maker Companion Medical for an undisclosed sum.