Edwards Lifesciences Launches Innovative Transcatheter Valve Repair System – A New Option for Treating Critically Ill Patients with Mitral Valve Regurgitation
Cutting-edge Innovation Has Received International Approvals, Supported by Clinical Research, Offering Increased Survival Rates and Reduced Complications in Patients with Severe Mitral Valve Regurgitation
Bangkok, Thailand: In an era of continuous advancements in medical technology, Edwards Lifesciences (NYSE: EW), a global leader in patient-focused innovations for structural heart disease, has announced a significant breakthrough with the launch of its Transcatheter Mitral Valve Repair System in Thailand. This system provides a new treatment option for patients suffering from mitral regurgitation (MR), which is one of the most common valvular heart diseases, affecting more than 175 million people worldwide in 2023, as reported by the U.S. National Center for Biotechnology Information (NCBI).
The system utilizes a transcatheter edge-to-edge repair (TEER) approach, enabling safe and effective treatment for patients with MR. It features independent grasping, atraumatic clasp and closure, and implant versatility, including the ability to elongate and navigate complex anatomy.
Importantly, this technology has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with degenerative mitral regurgitation (DMR), and CE Mark for the treatment of MR and tricuspid regurgitation (TR). The three-year outcomes from the pivotal CLASP IID trial showcase sustained benefits of this technology in treating DMR in a broad patient population. At three-years, the technology demonstrates favorable survival, significant and sustained MR reduction, and significant and consistent improvements in functional status and quality-of-life.
Michael Blackwell, Senior Director of Transcatheter Mitral and Tricuspid Therapies at Edwards Lifesciences APAC, said, “The availability of this transcatheter mitral valve repair system in Thailand represents a significant achievement in our ongoing efforts to advance treatment options for patients across the globe.”
Parameswaran Nair, Country Leader of Greater India and Southeast Asia at Edwards Lifesciences, stated, “We are proud of our 65-year legacy of leadership in this field and will continue to develop innovations for the ultimate benefit of patients, alongside building robust clinical evidence to drive changes in patient care. We are deeply committed to delivering more innovations that can transform Thai patients’ lives for the better and provide Thai physicians with more new treatment options.”
This innovation provides a significant step towards transforming the treatment of critically ill patients with valve regurgitation. With its safety and efficacy confirmed by study results, patients at high risk now have access to improved treatment options, enabling them to live longer with an enhanced quality of life, marking a significant advancement in medical care.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence, and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
