Edwards Lifesciences Receives FDA Approval for PASCAL Precision System for Tricuspid Valve Repair
Edwards Lifesciences Corporation (NYSE: EW), a global developer of patient-focused innovations for structural heart disease, has announced that the U.S. Food and Drug Administration (FDA) has approved its PASCAL Precision system for tricuspid valve repair. The approval expands access to transcatheter treatment for patients with symptomatic severe tricuspid regurgitation (TR), a condition that can significantly affect quality of life and functional capacity.
The PASCAL Precision system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy. Eligible patients must be considered at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team.
The FDA decision represents an important expansion of Edwards Lifesciences’ structural heart portfolio in the United States. With the addition of PASCAL Precision for tricuspid valve repair, the company stated that it is now the only company in the country offering a portfolio of both transcatheter repair and replacement therapies for the mitral and tricuspid valves.
In addition to the tricuspid approval, Edwards announced that the FDA has approved its PASCAL Ace with Capture Clarity system for use in degenerative mitral transcatheter edge-to-edge repair (M-TEER) procedures. The updated system introduces fluoroscopic indicators designed to help clinicians confirm when valve leaflets have been grasped, addressing a technically challenging step during mitral valve repair.
Together, the two regulatory milestones expand the company’s treatment options for patients with mitral and tricuspid valve disease while introducing a new procedural feature intended to support clinicians during mitral interventions.
PASCAL Precision Expands Treatment Options for Tricuspid Regurgitation
Tricuspid regurgitation occurs when the tricuspid valve does not close properly, allowing blood to flow backward through the valve. This can reduce the efficiency of the heart’s pumping function and contribute to symptoms that interfere with daily activities and overall well-being.
Patients with severe tricuspid regurgitation may experience substantial limitations in their functional status and quality of life. Treatment decisions depend on several factors, including the severity of the condition, the patient’s symptoms, response to medical management, overall health, surgical risk and the anatomy of the valve.
For some patients, conventional surgery may not be an appropriate option because of elevated procedural risk or other clinical considerations. Transcatheter edge-to-edge repair provides a less invasive approach in which a device is delivered through a catheter to bring valve leaflets closer together, helping reduce backward blood flow.
The FDA approval of PASCAL Precision introduces another transcatheter repair option for appropriately selected patients with symptomatic severe tricuspid regurgitation. The approved indication specifically addresses patients whose symptoms persist despite optimal medical therapy and who are considered to face intermediate or greater surgical risk.
Patient selection remains central to the treatment pathway. Under the approved indication, a multidisciplinary heart team must determine whether a patient is suitable for T-TEER. This assessment allows clinicians to consider individual clinical circumstances and valve anatomy before deciding whether a transcatheter procedure is appropriate.
The PASCAL Precision system is designed to support tricuspid valve repair in this patient population. Its availability in the United States gives clinicians an additional treatment option as they evaluate approaches to managing severe tricuspid regurgitation.
Edwards Strengthens Its Structural Heart Therapy Portfolio
The approval also strengthens Edwards Lifesciences’ position in the transcatheter mitral and tricuspid valve treatment markets. The company has developed a portfolio spanning repair and replacement approaches, allowing clinicians to consider different types of intervention according to patients’ needs.
Daveen Chopra, corporate vice president of transcatheter mitral and tricuspid therapies at Edwards Lifesciences, highlighted the company’s experience with the PASCAL system in mitral valve disease and the significance of extending its availability to tricuspid patients.
“The PASCAL system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US,” Chopra said.
Chopra added that the introduction of PASCAL for tricuspid repair complements Edwards’ existing transcatheter treatment offerings.
“With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal clinical results,” Chopra said.
The expanded portfolio is intended to give clinicians greater flexibility when determining treatment strategies for patients with structural heart disease. Repair and replacement technologies serve different clinical needs, and the availability of multiple approaches can help heart teams evaluate the most suitable intervention for each patient.
The FDA approval does not mean that every patient with tricuspid regurgitation will be eligible for the PASCAL Precision system. Instead, its use is defined by the approved indication, the patient’s symptoms and surgical risk, and the multidisciplinary heart team’s assessment of suitability for T-TEER.
Device Features Designed for Complex Valve Anatomy
Tricuspid valve interventions can present technical challenges because of differences in valve anatomy and the need to navigate the device into the appropriate position. Clinicians must assess the valve structure, position the repair system and capture the leaflets to achieve the intended treatment effect.
Santiago Garcia, MD, director of The Structural Heart Program at The Christ Hospital Health Network, emphasized the potential value of the PASCAL system’s design in addressing complex anatomies.
“The differentiated features of the PASCAL system provide many benefits in navigating complex and challenging anatomies, and it is exciting to now have this therapy available for our tricuspid patients in the US,” Garcia said.
The comments underscore the importance of device design and procedural usability in transcatheter valve repair. These procedures require clinicians to work with specialized delivery systems and imaging guidance to position the device and achieve effective leaflet capture.
By making PASCAL Precision available for tricuspid repair, Edwards aims to extend the clinical application of its technology beyond its established use in degenerative mitral regurgitation.
The company said the approval will allow clinicians to consider the system for a broader group of patients with tricuspid valve disease. However, individual treatment decisions will continue to depend on clinical assessment, anatomy and the patient’s overall condition.
FDA Approves PASCAL Ace with Capture Clarity for Mitral Repair
Alongside the tricuspid valve approval, Edwards Lifesciences announced FDA approval of the PASCAL Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair procedures.
The new system includes fluoroscopic indicators designed to provide confirmation when valve leaflets have been grasped. According to Edwards, this makes it the first FDA-approved TEER device to incorporate fluoroscopic indicators specifically intended to confirm leaflet capture.
Leaflet grasping is a critical stage of mitral valve repair. The clinician must position the device and securely capture the valve leaflets before completing the repair. Determining whether the leaflets have been successfully grasped can be challenging, particularly when procedural anatomy and device positioning increase complexity.
The Capture Clarity indicators are designed to give clinicians an additional visual cue during this process. By supporting confirmation of leaflet capture under fluoroscopy, the feature is intended to simplify an important procedural step and increase confidence during device placement.
Garcia described the technology as an extension of the PASCAL system’s established design.
“Building on the PASCAL system’s intuitive design, the Capture Clarity indicators provide a novel and easy way of confirming leaflet capture, which is critical and can be challenging. This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome,” Garcia said.
The feature addresses a procedural consideration that can influence the workflow of mitral TEER. Fluoroscopy is commonly used during catheter-based structural heart procedures to provide real-time imaging of devices and their movement within the heart. The addition of indicators designed to confirm leaflet capture gives clinicians another source of visual information during the intervention.
The company expects the feature to support procedural decision-making by helping clinicians assess whether the device has engaged the intended valve leaflets. Its intended role is to make the capture step easier to evaluate, although clinical outcomes remain dependent on a range of patient-, anatomy- and procedure-related factors.
The PASCAL Ace with Capture Clarity approval applies to degenerative mitral TEER procedures. It is separate from the FDA approval of PASCAL Precision for tricuspid valve repair, with each authorization addressing a distinct clinical application.
CLASP IITR Trial Data to Be Presented at TCT
Edwards Lifesciences also announced that one-year data from the CLASP IITR pivotal trial evaluating the PASCAL tricuspid system will be presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT).
TCT is an annual scientific symposium organized by the Cardiovascular Research Foundation and serves as a forum for sharing clinical research and developments in interventional cardiovascular medicine.
The planned presentation will provide an opportunity for clinicians and researchers to review one-year findings from the pivotal trial. Such follow-up data can help characterize treatment performance and patient outcomes over time following a transcatheter intervention.
The announcement did not provide detailed one-year efficacy or safety results from the CLASP IITR trial. Therefore, specific conclusions about the magnitude or durability of clinical benefit cannot be drawn from the approval announcement alone. Further assessment will depend on the data presented and the details of the trial population, endpoints and follow-up.
Clinical evidence is an important component of evaluating transcatheter valve therapies. For patients with severe tricuspid regurgitation, relevant considerations include changes in symptoms, functional capacity and quality of life, along with procedural safety and longer-term outcomes.
The forthcoming presentation will add to the available evidence concerning the PASCAL tricuspid system and may help clinicians better understand its role in treating appropriately selected patients.
Advancing Transcatheter Care for Mitral and Tricuspid Valve Disease
The two FDA approvals highlight Edwards Lifesciences’ continued development of technologies for structural heart disease. PASCAL Precision expands the company’s tricuspid valve repair offering, while PASCAL Ace with Capture Clarity introduces a feature intended to support leaflet-capture confirmation during degenerative mitral TEER.
The tricuspid approval is particularly relevant for patients with symptomatic severe regurgitation who continue to experience limitations despite medical therapy and who are considered at elevated risk for surgery. For these individuals, a catheter-based repair option may offer an alternative to conventional surgical treatment when a multidisciplinary heart team determines that the procedure is appropriate.
Meanwhile, the Capture Clarity system focuses on a specific procedural challenge in mitral valve repair. Its fluoroscopic indicators are designed to help clinicians confirm leaflet grasping, an essential step in achieving the intended repair.
Both developments reflect the broader direction of structural heart care toward specialized, catheter-based therapies and procedural technologies designed to address complex valve anatomy. As these treatments become available, clinical evaluation and careful patient selection remain essential to ensuring that each intervention is used in the population for which it is intended.
With the PASCAL Precision approval, Edwards Lifesciences has expanded its U.S. tricuspid treatment portfolio and strengthened its presence across transcatheter mitral and tricuspid repair and replacement. The upcoming presentation of one-year CLASP IITR pivotal trial data at TCT will provide an additional opportunity to examine the clinical evidence supporting its tricuspid valve repair technology.
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. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra, statements regarding expected product benefits, including the benefits of the novel features of the device, statements regarding increasing confidence for successful results, and other statements that are not historical facts.
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. Investors are cautioned not to unduly rely on such forward-looking statements.