Corcym Reports Positive Seven-Year Mid-Term Data for Perceval Plus Sutureless Aortic Valve in MANTRA Clinical Study
Corcym, a global medical device company focused on cardiac surgery, has announced positive mid-term clinical findings from a sub-analysis of its MANTRA clinical study evaluating the Perceval Plus sutureless aortic heart valve. The results were presented in an oral presentation at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) 2026, highlighting the valve’s durability, safety, hemodynamic performance and associated improvements in patients’ quality of life.
The analysis included 708 patients treated with the Perceval Plus valve in routine clinical practice across 45 centers participating in the ongoing international, prospective MANTRA registry. The findings represent the longest follow-up currently reported for the Perceval Plus valve and its FREE tissue treatment within an international multicenter study, with several patients reaching seven years of follow-up.
The results demonstrated high freedom from structural valve deterioration and aortic valve reoperation, alongside a low rate of permanent pacemaker implantation at 30 days. Patients also experienced improvements in functional status and quality-of-life measurements following valve implantation, with benefits sustained over the available follow-up period.
The findings provide additional clinical evidence supporting the continued evaluation of Perceval Plus as a surgical treatment option for patients requiring aortic valve replacement. They also underscore Corcym’s broader strategy of developing technologies intended to support evolving cardiac surgical techniques, including minimally invasive cardiac surgery (MICS), endoscopic procedures and robotic-assisted approaches.
Positive Clinical Findings from the MANTRA Study
The Perceval Plus sub-analysis was conducted as part of Corcym’s ongoing MANTRA study, a prospective, international, multicenter registry designed to collect clinical information on patients receiving the company’s sutureless aortic heart valve in routine clinical practice.
The analysis included 708 patients treated at 45 centers, providing evidence from a broad clinical setting rather than a single institution. The study continues to enroll patients, and the reported analysis includes individuals with follow-up extending to seven years.
According to the findings presented at EACTS 2026, Perceval Plus demonstrated favorable mid-term outcomes across several important measures of valve performance and patient recovery.
Key findings included:
- 99.7% freedom from structural valve deterioration (SVD) from three to seven years.
- 96.6% freedom from aortic valve reoperation from four to seven years.
- 3.7% permanent pacemaker implantation (PPI) rate at 30 days.
- Improvements in functional status, with 96.3% of patients classified as New York Heart Association (NYHA) class I or II at 30 days.
- Improvements in patient-reported quality of life, measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) and the EQ-5D-5L visual analogue scale (VAS).
These outcomes are relevant to the evaluation of surgical heart valves because durability, postoperative complications, hemodynamic performance and patient-reported well-being are important considerations when assessing the clinical value of a valve replacement technology.
Structural valve deterioration refers to changes in the structure or function of a prosthetic heart valve that can impair its performance over time. Freedom from structural valve deterioration is therefore an important measure in determining how well a replacement valve maintains its intended function during follow-up.
Similarly, freedom from valve reoperation provides insight into the proportion of patients who do not require another surgical procedure involving the replaced valve during the specified follow-up period.
The findings reported by Corcym indicate that the Perceval Plus valve maintained a favorable mid-term performance profile in the patients included in the analysis. However, the results represent observational registry data, and the reported freedom-from-event measures should be interpreted according to their respective follow-up intervals rather than as outcomes applying uniformly to every patient over seven years.
Favorable Hemodynamic Performance and Valve Durability
Michael Ibrahim, M.D., Ph.D., of the University of Virginia Health University Medical Center, the lead author of the presentation, emphasized the importance of the extended follow-up period and the findings related to valve performance.
“This large study provides the longest clinical follow-up currently reported for the Perceval Plus valve and its FREE tissue technology, offering valuable insights into their sustained clinical and hemodynamic performance over time,” Dr. Ibrahim said.
He noted that the data demonstrated a favorable hemodynamic profile, characterized by durably low transvalvular gradients and minimal paravalvular regurgitation, alongside low rates of reintervention and permanent pacemaker implantation.
Transvalvular gradients refer to the pressure difference across a heart valve as blood flows through it. Lower gradients generally indicate less resistance to blood flow through the valve, although interpretation depends on factors such as valve size, patient characteristics and the overall clinical setting.
Paravalvular regurgitation occurs when blood leaks around the outside of a prosthetic valve rather than flowing exclusively through it. Minimizing this leakage is an important consideration in valve replacement because significant regurgitation can affect cardiac performance and patient outcomes.
Dr. Ibrahim also highlighted the high freedom from structural valve deterioration and valve-related reintervention observed during follow-up, describing these findings as evidence of an excellent mid-term durability profile.
The extended observation period is particularly relevant because surgical heart valves must maintain appropriate function over time. Mid-term clinical data can help clinicians and researchers understand how a device performs beyond the immediate postoperative period and provide information that complements early safety and procedural outcomes.
Continued follow-up through the MANTRA registry may provide additional information on the longer-term performance of Perceval Plus as more patients reach later assessment milestones.
Perceval Plus: A Sutureless and Collapsible Surgical Aortic Valve
Perceval Plus is a sutureless, collapsible surgical aortic heart valve developed by Corcym. The company describes it as the only valve in its category combining a sutureless design with a collapsible structure.
Conventional surgical aortic valve replacement typically involves securing the replacement valve to the patient’s native annulus using sutures. Sutureless valve technologies are designed to simplify the valve implantation process by reducing the need for conventional suturing during placement.
The Perceval Plus design is intended to support different surgical scenarios, including minimally invasive procedures. Its collapsible configuration may be particularly relevant when surgeons seek to perform valve replacement through smaller incisions or endoscopic approaches.
Minimally invasive cardiac surgery aims to reduce the size of surgical incisions compared with conventional open procedures while enabling surgeons to perform the required intervention. Depending on the patient, anatomy and procedure, these approaches may offer advantages in surgical access and recovery. Robotic-assisted cardiac surgery is another evolving field in which specialized instruments and visualization technologies support complex procedures through limited access points.
Corcym positions Perceval Plus as part of its efforts to support the development of these surgical techniques. The company’s strategy includes combining specialized cardiac devices with technologies and educational resources intended to help surgeons adopt evolving approaches to treatment.
The valve’s design, manufacturing process and tissue treatment are central elements of its development.
FREE Tissue Treatment and LANCELOT Manufacturing Technology
Perceval Plus incorporates Corcym’s FREE next-generation tissue treatment, which is designed to address two factors associated with tissue calcification: phospholipids and aldehydes.
Calcification is an important consideration in the performance of bioprosthetic heart valves. Calcium deposits can accumulate in valve tissue over time and may contribute to structural deterioration, potentially affecting valve function and durability.
Corcym’s FREE tissue treatment is intended to address these factors as part of the company’s approach to developing valve materials designed for sustained performance. The clinical findings from the MANTRA sub-analysis provide information on the valve incorporating this treatment, although the registry analysis does not, by itself, establish the independent contribution of the tissue treatment to the observed outcomes.
The company also uses its proprietary LANCELOT advanced manufacturing process. This process includes zero-pressure shaping and laser cutting of the pericardium, the tissue used in the valve’s construction.
According to Corcym, these manufacturing techniques are designed to optimize valve performance and consistency. Manufacturing precision is important for surgical heart valves because the geometry and characteristics of the tissue components can influence the device’s structural properties and functional performance.
The combination of valve design, tissue processing and manufacturing methods forms part of Corcym’s overall strategy for developing surgical valve technologies.
Improvements in Functional Status and Quality of Life
In addition to valve durability and safety, the MANTRA sub-analysis evaluated changes in patients’ functional status and quality of life after implantation.
The findings indicated that 96.3% of patients were classified as NYHA class I or II at 30 days, representing a 32% improvement from baseline. More than 95% of patients maintained this functional status at three-year follow-up.
The NYHA classification system is commonly used to describe the extent to which heart disease limits physical activity. Class I generally indicates no limitation of ordinary physical activity, while class II indicates mild limitation. Movement toward these categories can reflect improvements in symptoms and functional capacity, although individual patient experiences may vary.
The reported findings suggest that many patients experienced an improvement in functional status following surgery, with the majority maintaining the specified classification through three years of follow-up.
The study also reported improvements in patient-reported quality of life using the KCCQ-12 questionnaire.
The mean KCCQ-12 score increased from 59.6 at baseline to 72.8 at 30 days, representing a reported 19% improvement. At one year, the mean score increased further to 85.4, corresponding to a reported 31% improvement from baseline.
The KCCQ-12 measures health status in patients with cardiovascular disease, including symptoms, physical limitations and the effects of the condition on daily activities and quality of life. Higher scores generally indicate better reported health status.
The analysis also evaluated quality of life using the EQ-5D-5L visual analogue scale, which allows patients to rate their overall health.
The mean EQ-5D-5L VAS score increased from 65.2 at baseline to 72.7 at 30 days, representing an 11% improvement. At one year, the mean score reached 79.3, corresponding to an 18% improvement from baseline.
Taken together, these findings indicate improvements across multiple measures of functional status and patient-reported well-being following Perceval Plus implantation. The results complement the reported valve performance outcomes by providing information on how patients experienced their health after surgery.
The findings are based on the available study data and do not establish that the valve alone caused every observed improvement, as postoperative outcomes can also be influenced by the underlying disease, the surgical procedure and other patient-specific factors.
Additional Perceval Plus Presentations at EACTS 2026
Beyond the oral presentation, Perceval Plus was featured in six electronic posters and a Mini-Access Multi-Procedure at EACTS 2026.
The additional presentations form part of Corcym’s broader scientific program at the meeting, providing opportunities to share information about its cardiac surgery technologies and their clinical applications.
The company has made the complete schedule of Perceval Plus and Corcym presentations available through its EACTS 2026 scientific program.
Participation in professional meetings such as EACTS allows medical device companies to present clinical evidence, discuss emerging surgical approaches and engage with cardiac surgeons and other specialists involved in cardiovascular care.
For Perceval Plus, the seven-year follow-up data add to the body of clinical information being evaluated as part of the ongoing MANTRA registry.
Corcym Introduces Two New Devices in Its Memo Portfolio
Corcym also announced the launch of two devices in its Memo portfolio at EACTS 2026: TriMemo and Memo 4D Curve. Both devices recently received U.S. Food and Drug Administration (FDA) clearance and were associated with first-in-human procedures in the United States, according to the company.
TriMemo is designed for tricuspid valve repair and is described by Corcym as the first device capable of delivering true three-dimensional physiologic motion to the tricuspid valve. The company also identifies it as the first tricuspid device to incorporate its proprietary Memo technology.
The tricuspid valve regulates blood flow between the right atrium and right ventricle. Disorders affecting this valve can interfere with normal blood flow and may contribute to cardiovascular complications. Surgical repair devices are developed to help surgeons address valve abnormalities while preserving or restoring appropriate valve function.
Memo 4D Curve is a nitinol-based, semi-rigid mitral annuloplasty device featuring an open configuration. It is intended to provide surgeons who prefer an open-ring design with access to the three-dimensional motion-preservation capabilities of the Memo platform.
Nitinol is a nickel-titanium alloy used in medical devices because of its distinctive mechanical properties, including flexibility and shape-memory characteristics. In annuloplasty devices, design and material selection are important considerations in supporting the intended repair of the valve’s surrounding structure.
The introduction of TriMemo and Memo 4D Curve expands Corcym’s portfolio of technologies for cardiac valve surgery. Their recent FDA clearances represent regulatory milestones, while first-in-human procedures mark an early stage of clinical use. Further clinical experience will be important in evaluating their performance across relevant patient populations and surgical settings.
Supporting Surgeons Through Training and Technology
Corcym is exhibiting at Booth No. 30 at the International Barcelona Convention Center (CCIB) during EACTS 2026.
Christian Mazzi, Chief Executive Officer of Corcym, emphasized the company’s commitment to supporting cardiac surgeons as the specialty evolves toward increasingly sophisticated surgical approaches.
“Our commitment to the cardiac surgeon is absolute, and as the specialty evolves, we are leading the way in preparing surgeons to uplevel their skills in order to confidently move into MICS and robotic surgery,” Mazzi said.
He also highlighted the role of Perceval Plus in the company’s strategy to support the transition toward minimally invasive and robotic-assisted procedures.
“As the only sutureless, collapsible surgical aortic valve, Perceval Plus is at the core of this transition. We are surrounding our innovative product offerings with new technologies, such as the CRIMSON AI-assisted CT analysis platform for aortic valve replacement planning, and our Corcym Academy, focused on training the Surgeons of the Future, to ensure that cardiac surgery remains at the forefront in improving patient lives,” he added.
CRIMSON is an AI-assisted computed tomography analysis platform intended to support planning for aortic valve replacement. Such planning technologies may help clinicians assess anatomical information relevant to procedural preparation, while Corcym Academy focuses on education and training for surgeons adopting advanced cardiac surgical techniques.
These initiatives reflect the company’s approach of combining devices, planning technologies and professional education to support surgical practice.
Continued Evaluation of Surgical Heart Valve Technologies
The positive mid-term findings from the MANTRA sub-analysis represent an important addition to the clinical evidence available for Perceval Plus and its FREE tissue treatment. The reported durability measures, low 30-day permanent pacemaker implantation rate and improvements in functional status and quality of life provide insight into outcomes among patients treated at 45 centers.
The ongoing nature of the MANTRA registry means additional follow-up may further clarify the valve’s performance over time. Longer-term evidence will remain important for understanding structural valve deterioration, reoperation rates and other clinically relevant outcomes.
Alongside the Perceval Plus findings, Corcym’s introduction of TriMemo and Memo 4D Curve and its continued investment in surgical planning and education demonstrate its broader focus on advancing cardiac surgery technologies.
As minimally invasive and robotic-assisted approaches continue to develop, medical device innovation, clinical evidence and surgeon training will remain important components of efforts to improve procedural options and patient care. Corcym’s activities at EACTS 2026 highlight its work across these areas, with Perceval Plus remaining a central part of its surgical aortic valve portfolio.
About Corcym
Corcym is the only global medical device company dedicated to cardiac surgeons, providing the best solutions to help their patients fight structural heart disease. Founded on five decades of trusted partnerships with cardiac surgeons and a comprehensive portfolio of structural heart solutions, Corcym’s innovative technologies offer surgeons a wide range of repair and replacement options for both open-heart and minimally invasive cardiac surgery techniques. https://www.corcym.com/ .