Corcym has announced positive mid-term data from a sub-analysis of its Perceval Plus sutureless aortic heart valve as part of the MANTRA clinical trial.
The data featured in an oral presentation today at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS, 7–10 October, Barcelona, Spain).
The study is the longest follow-up available for Perceval Plus and the FREE tissue treatment from an international multicentre study, and demonstrated excellent durability, safety and quality of life improvements, the company says in a press release.
Perceval Plus is a sutureless and collapsible aortic surgical valve. The valve features the company’s FREE next generation tissue treatment addressing the two main causes of calcification, phospholipids and aldehydes. Its proprietary LANCELOT advanced manufacturing process includes zero-pressure shaping and laser cutting of the pericardium to optimize valve performance and consistency.
“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,” said lead author Michael Ibrahim (University of Virginia Health University Medical Center, Charlottesville, USA). “These data demonstrate a favourable ha emodynamic profile, characterised by durably low transvalvular gradients and minimal paravalvular regurgitation, along with low rates of reintervention and permanent pacemaker implantation. The high freedom from structural valve deterioration and valve-related reintervention observed during follow-up demonstrates an excellent mid-term durability profile.”
The study is a subanalysis including 708 patients treated with Perceval Plus in routine clinical practice at 45 centres as part of the company’s ongoing MANTRA study, a prospective multicentre international registry. The subanalysis includes many patients reaching seven-year follow-up and is currently enrolling patients.
Results demonstrated 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, and 3.7% permanent pacemaker implantation (PPI) rate at 30 days.
Quality of life improvements were also documented, including 96.3% of patients classified as New York Heart Association (NYHA) class I-II at 30 days (a 32% improvement from baseline), with more than 95% of patients sustaining that status at three-year follow-up, 19% improvement in mean Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores from baseline at 30 days (59.6±23.3 to 72.8±22.1), substantially increasing to 31% improvement from baseline at one year (59.6±23.3 to 85.4±17.6), 11% improvement in mean EQ-5D-5L VAS scores from baseline at 30 days (65.2±20.2 to 72.7±17.3), increasing to 18% improvement from baseline at one year (65.2±20.2 to 79.3±14.8).
Also at EACTS, Corcym is launching two new devices in its Memo portfolio: TriMemo and Memo 4D Curve, both of which recently celebrated FDA clearance and first-in-human procedures in the USA. TriMemo is the first device capable of delivering true three-dimensional physiologic motion to the tricuspid valve, and the first tricuspid device to leverage proprietary Memo technology. Memo 4D Curve is a nitinol-based, semi-rigid mitral annuloplasty device with an open configuration, giving surgeons who prefer an open ring access to the three-dimensional motion preservation capability of the Memo platform.
“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,” said Christian Mazzi, CEO of Corcym. “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.”
