Edwards Granted CE Mark For First Transcatheter Tricuspid Therapy
IRVINE, Calif., April 30, 2018 -- 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 received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation. The Cardioband Tricuspid System is the first commercially available transcatheter therapy for the treatment of tricuspid heart valve disease.
"Although open-heart surgical valve repair is practiced today, it has not been performed frequently for those suffering from tricuspid regurgitation, despite evidence of increased mortality in these patients," said Prof. Georg Nickenig, chief, Department of Cardiology, University Hospital, Bonn, Germany. "Now with the European approval of the Cardioband Tricuspid System as the first transcatheter tricuspid therapy, patients can have access to a minimally invasive treatment designed to reduce tricuspid regurgitation and improve their symptoms and quality of life."
The Cardioband Tricuspid System is delivered via a transfemoral approach and is designed to reduce tricuspid regurgitation through annular reduction. It enables precise positioning to a patient's specific anatomy and real-time adjustment with simultaneous confirmation of results. It is the same design and implant technique as is used for the Cardioband Mitral System.
"We are very pleased to be developing the most comprehensive product portfolio to address both mitral and tricuspid valve disease and to demonstrate continued progress on this robust pipeline of innovative transcatheter therapies for patients in need," said Bernard Zovighian, corporate vice president, transcatheter mitral and tricuspid therapies. "The clinical results of the TRI-REPAIR CE Mark study with the Cardioband Tricuspid System demonstrate the promise of this treatment option for those with tricuspid regurgitation. We are committed to building a significant body of clinical evidence, including the collection of real-world data, on this important new therapy for patients who have few or no other treatment options."
Data on the Cardioband Tricuspid System will be presented in May at EuroPCR 2018. The Cardioband System is not approved for commercial sale in the United States.
Edwards acquired the Cardioband System from Valtech Cardio in January 2017, and the receipt of the CE Mark is one of the pre-specified milestones that prompts a distribution of cash and stock totaling approximately $50 million to the former investors of Valtech Cardio.
Prof. Nickenig has received compensation from Edwards for educational and training activities.
About Edwards LifesciencesEdwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.edwards.com and follow us on Twitter @EdwardsLifesci.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, statements by Prof. Nickenig and Mr. Zovighian, as well as statements regarding potential product benefits and releases of clinical data. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, unanticipated outcomes after longer term clinical experience, as well as unexpected regulatory, reimbursement, manufacturing, or quality-related delays or issues. These and other additional factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2017. These filings, along with important safety information about our products, may be found at www.edwards.com.
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