Edwards Lifesciences, Inc. (NYSE:EW) Acquires EMEA Commercialization Rights to World’s First and Only FDA Approved Anti-Clog Device for Chronic Kidney Disease at the European Society of Cardiology Meeting in Munich
Edwards Lifesciences, Inc. (NYSE:EW) announced today that it has acquired commercialization rights to the world’s first and only FDA approved anti-clog device for chronic kidney disease (CKD) in Europe, Middle East and Africa (EMEA).
The terms of the deal were not disclosed. The acquisition was completed on August 23, 2017.
Edwards Lifesciences is a medical device company headquartered in Irvine, California with corporate offices in Irvine, California and a presence in over 100 countries worldwide. With a strong emphasis on research & development, Edwards Lifesciences is dedicated to advancing the treatment of vascular disease through innovative device designs, manufacturing processes and systems for quality assurance.
Edwards Lifesciences has been named one of Fortune magazine’s “100 Best Companies to Work For” for seven years running. To learn more about Edwards Lifesciences visit www.[edwardlifesciences].com.
The European Society of Cardiology (ESC) is the world’s largest cardiology society. ESC was founded in 1950 and has nearly 80,000 members from more than 150 countries worldwide. The ESC mission is to reduce the burden of cardiovascular disease through education, guidelines and educational outreach. The society is governed by a body of elected and appointed representatives chosen by its membership. The ESC’s governing body also includes representatives from all member countries and other regions of Europe.
The EMEA Commercialization Rights to the World’s First and Only FDA Approved Anti-Clog Device for Chronic Kidney Disease at the European Society of Cardiology Meeting in Munich: A blog around those who suffer from chronic kidney disease.
The EMEA Commercialization Rights to the World’s First and Only FDA Approved Anti-Clog Device for Chronic Kidney Disease at the European Society of Cardiology Meeting in Munich: A blog around those who suffer from chronic kidney disease.
The EMEA Commercialization Rights to the World’s First and Only FDA Approved Anti-Clog Device for Chronic Kidney Disease at the European Society of Cardiology Meeting in Munich: A blog around those who suffer from chronic kidney disease.
The EMEA Commercialization Rights to the World’s First and
Edwards Lifesciences Corporation (NYSE:EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has acquired the EMEA commercialization rights to the world’s first and only fully integrated and FDA approved anti-clog technology for chronic kidney disease.
The agreement includes the EMEA commercialization rights to Edwards Lifesciences’ proprietary Anti-Clog® technology, which is designed to prevent clogging of central venous catheters in patients undergoing peritoneal dialysis.
Edwards Lifesciences’ Anti-Clog technology has been demonstrated in two large clinical studies to be effective in preventing blood clots from accumulating and blocking the flow of blood through central venous catheters used during chronic kidney disease treatments. The catheters are implanted surgically into a vein in the neck or chest so that they can be accessed by medical equipment, such as a dialysis machine, without having to remove them.
Patients who experience clogging of the device can suffer serious complications, including damage to organs such as the kidneys or other tissues. In addition, patients may require additional procedures to access their catheter, resulting in prolonged hospital stays and increased costs
Palm Beach Gardens, FL – Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced today that it has acquired the commercialization rights to the HemoSphereTM platform for Europe, Middle East and Africa. The agreement is part of a global licensing deal with Retina Implant AG.
The HemoSphere platform is the world’s first and only FDA approved anti-clog device for chronic kidney disease (CKD). It is a closed irrigation system that flushes blood from the dialysis catheter during dialysis to prevent clogging. The HemoSphere platform reduces catheter occlusions by up to 92% helping to reduce unplanned hospitalizations, while providing patients greater confidence in their daily treatment.
“This is an important addition to our interventional nephrology franchise,” said Michael A. Mussallem, Edwards’ chairman and chief executive officer. “The HemoSphere platform will allow us to bring effective therapies to patients across our geographic footprint.”
Edwards Lifesciences is dedicated to improving patient outcomes through innovative medical solutions that treat structural heart disease and critically ill patients. For more information about Edwards Lifesciences, please visit
BETHESDA, Md., Aug. 02, 2017 (GLOBE NEWSWIRE) — Edwards Lifesciences Corporation (NYSE:EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has entered into an agreement with Atreyu Therapeutics to acquire exclusive commercialization rights in Europe and select other countries outside of the United States to a device that prevents clotting in dialysis patients. The company presented data at EuroPCR 2017 from a large European clinical trial supporting the effectiveness of the device.
“This acquisition is a great opportunity to differentiate Edwards’s critical care product offering and expand our presence internationally in treating dialysis patients,” said Larry L. Wood, Edwards’ chief operating officer for core valve therapies. “We are excited about this new opportunity to help these patients.”
The EMEA commercialization rights will be acquired for approximately $62 million including upfront and potential milestone payments.
Chronic kidney disease (CKD) is a serious public health issue that affects more than 30 million adults in the United States1, and more than 37 million worldwide.2 CKD progresses over time when the kidneys are not functioning properly and can lead to kidney failure (also known as end-stage renal disease, or ESRD).3 It is estimated that one in three adults with diabetes have CKD,4 and approximately 50 percent of people with CKD are not diagnosed until they reach an advanced stage.5
“Chronic kidney disease is a global public health problem that needs more attention,” said Professor Clarence E. Davis, MD, FACP, FASN, director of nephrology at Grady Memorial Hospital in Atlanta and chair of the African American Study of Kidney Disease & Hypertension (AASK) study. “This new device has the potential to reduce the risk of clots forming in patients with chronic kidney disease by providing them with continuous blood flow. If this reduces the rate of CVAs it could be a game changer.”
To be notified when more clinical data on the device will be presented at upcoming meetings please visit www.edwards.com/esrdtherapy.
Edwards Lifesciences is
“I am pleased to report that we are on track to launch the NephroSonic™ device in Europe and the Middle East later this year,” said Michael A. Mussallem, chairman and chief executive officer at Edwards Lifesciences. “We believe that this technology will change the way physicians treat dialysis patients and offer a significant improvement in reducing clots. We are proud of this milestone as it enables us to further advance our commercial presence in EMEA, which is an important region for Edwards.”
“This technology is very exciting because it may help reduce these potentially deadly clots,” said Dr. Hossam Khodeir, cardiovascular surgeon at Prince Sultan Cardiac Center in Riyadh, Saudi Arabia. “The NephroSonic™ device could be particularly useful for patients with difficult access due to small vessels or high-risk anatomy.”
The European market for hemodialysis catheters was estimated at $250 million in 2013, according to GlobalData.
