Hemosphere said that its HeRO Vascular Access Device provides access for hemodialysis similar to a conventional graft. The device can be surgically implanted completely under the skin and its design bypasses central venous damage caused by catheters.
The HeRO Vascular Access Device is made up of two pieces that are surgically implanted under the skin. During surgery, a reinforced tube (called the outflow component) is inserted directly into a large vein in the neck. X-ray is used to direct the tube past any blockages that have caused trouble for other access sites.
Hemosphere claimed that the HeRO has the potential to establish a new standard of vascular access care to reduce long-term catheter use. The device provides a new option that improves a patient’s quality of life by increasing the effectiveness of hemodialysis treatment and reducing a patient’s risk of developing an often-fatal systemic infection.
Before the introduction of HeRO, hemodialysis patients received a tunneled dialysis catheter when the damage to their central venous systems prevented them from supporting a fistula or graft.
Doris Engibous, president and CEO of Hemosphere, said: “Reaching this significant medical milestone demonstrates increasing physician acceptance of the HeRO Vascular Access Device and its positive contribution toward improved quality of life for kidney disease patients. The strong clinical results, and the subsequent increasing adoption of the device, reinforce that HeRO can provide improved vascular access performance and reduce healthcare costs compared to catheters.”
Brad Grimsley, vascular access surgeon at Texas Vascular Associates in Dallas, said: “The HeRO device allows for better and more efficient dialysis, so many of my patients who have been implanted with HeRO say they feel better and have more energy. Because HeRO is implanted under the skin, it has a significantly lower risk of potentially life-threatening infections than a catheter and allows my patients to enjoy daily activities, like showering or swimming, without worrying about exposing their access to germs and bacteria.”