Positive New Data on Corcym’s Perceval Plus Sutureless Aortic Heart Valve Encompasses up to 7-Year Follow-up

Corcym, a global medical device company dedicated to cardiac surgery, today announced that positive mid-term data from a sub-analysis of its Perceval Plus sutureless aortic heart valve as part of its MANTRA clinical trial was featured in an oral presentation today at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS). The study is the longest follow-up available for Perceval Plus and the FREE tissue treatment from an international multicenter study, and demonstrated excellent durability, safety and quality of life improvements.

Perceval Plus is the only sutureless and collapsible aortic surgical heart valve. Its unique design performs in any surgical scenario and is optimal for endoscopy and robotics. 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, MD, PhD, at the University of Virginia Health University Medical Center. “These data demonstrate a favorable hemodynamic profile, characterized 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 presented at EACTS is a sub-analysis including 708 patients treated with Perceval Plus in routine clinical practice at 45 centers as part of the company’s ongoing MANTRA study, a prospective multicenter international registry. The sub-analysis includes many patients reaching 7-year follow-up and is currently enrolling patients.

Highlights from the Perceval Plus sub-analysis include:

• 99.7% freedom from structural valve deterioration (SVD) from 3 to 7 years
• 96.6% freedom from aortic valve reoperation from 4 to 7 years
• 3.7% permanent pacemaker implantation (PPI) rate at 30 days

• Quality of life improvements:
  • 96.3% of patients classified as NYHA class I-II at 30 days (a 32% improvement from baseline), with more than 95% of patients sustaining that status at 3 year follow-up
  • 19% improvement in mean 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 1 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 1 year (65.2 20.2 to 79.3 14.8)

In addition to the oral presentation, Perceval Plus is featured in six e-Posters and a Mini-Access Multi-Procedure at EACTS. To view the complete schedule of Perceval Plus and Corcym presentations in the scientific program, click here.

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 U.S. 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.

Corcym is exhibiting at EACTS Booth #30 at the International Barcelona Convention Center (CCIB).

“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, Chief Executive Officer 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.”

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/ .

High-resolution product images and additional materials are available upon request.

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