1,000 patients nationwide have now received the device
from Minnesota-based Hemosphere, Inc.
February 24, 2010 – Eden Prairie, Minn. – One thousand end stage renal disease patients have now benefited from a novel device that provides vital access to their blood for filtering and replacement kidney function and reduces the risk of potentially fatal bacteremia infection.
The HeRO® Vascular Access Device, produced by Hemosphere, Inc., in Eden Prairie, Minn., provides access for hemodialysis similar to a conventional graft. The device is surgically implanted completely under the skin and its innovative design bypasses central venous damage caused by catheters. More than 1,000 patients in over 220 hospitals across the United States have received the device since its commercialization in May 2008.
“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,” said Doris Engibous, President and CEO of Hemosphere, Inc. “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.”
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. Catheters have a number of disadvantages, including high rates of life-threatening infection, inadequate dialysis compared to fistulas and grafts, and are widely known to cause damage to the central veins over time.
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.
“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,” said Dr. Brad Grimsley, vascular access surgeon at Texas Vascular Associates in Dallas, who performed the 1,000th implant. “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.”
How HeRO Works
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. A regular dialysis graft is sewn to an artery, just like a conventional graft. The graft is then joined to the outflow component with a special proprietary connector. Once the system is in place, blood will flow from the artery through the graft and
Internal Use Only: 15-0002, Press Release 1,000th Implant
outflow component into the heart. Unlike a catheter, there is continuous blood flow even when a patient is not receiving dialysis treatment.
“Our customers, including our earliest supporters in the clinical trial, as well as the dialysis care centers and our most recent certified surgical implanters, are the key to our success. Without their belief and support, HeRO would not be the solution for access challenged patients,” said Engibous. “We are committed to collaborating with clinicians and other members of the dialysis care continuum to improve clinical outcomes for patients for years to come.”
About Hemosphere, Inc. Hemosphere, Inc., is leading innovation and collaboration in the global development and commercialization of technologies that revolutionize care and restore quality of life for end-stage renal disease patients with compromised vasculature.
For more information on Hemosphere, Inc and the HeRO® Vascular Access Device, visit the company’s Web site at www.heroaccess.com.
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