Nyra Medical has announced enrolment of the first patient in the ENHANCE early feasibility study (EFS) evaluating the investigational Carlen system, its novel transcatheter mitral valve repair (TMVr) technology.
The enrolment represents a milestone in Nyra Medical’s clinical development strategy and follows encouraging first-in-human clinical experience where Carlen restored native mitral valve coaptation while preserving physiologic valve function in treated patients, the company said in a press release. The ENHANCE EFS is designed to evaluate the safety, feasibility, and procedural performance of the Carlen system in patients suffering from symptomatic functional mitral regurgitation (FMR).
The multicentre study includes structural heart programmes in both the USA and Brazil.
“The initiation of our ENHANCE early feasibility study reflects years of engineering innovation, disciplined clinical preparation, and close collaboration with world-renowned physicians,” said Jennifer Mischke, senior vice president of clinical, regulatory & quality at Nyra Medical. “This milestone validates both the strength of our clinical development programme and our commitment to bringing physicians an innovative treatment option designed to expand access to transcatheter mitral valve repair. We are excited to begin generating the clinical evidence that will support future regulatory and commercial milestones.”
Unlike conventional transcatheter edge-to-edge repair (TEER) approaches, the investigational Carlen system is designed to augment the native mitral leaflet without sutures, tethers, or permanent alteration of valve anatomy. The device is intended to restore leaflet coaptation while maintaining physiologic leaflet motion and preserving future treatment options.
“The first enrolment in the ENHANCE study marks an important step forward in evaluating a fundamentally different approach to treating functional mitral regurgitation,” said Alexandre Abizaid (University of São Paulo Hospital, São Paulo, Brazil) whose centre was the first enrolling clinical site in Brazil. “The ability to enhance native leaflet function while maintaining the natural mechanics of the mitral valve represents an exciting area of innovation, and we are pleased to contribute to the clinical evaluation of this technology. I would like to extend my congratulations to Dr Fabio Sandoli de Brito for performing the first procedure and thank the multidisciplinary team whose collaboration and commitment made this achievement possible. Milestones like this are only possible through exceptional teamwork and a shared dedication to advancing patient care.”
“Functional mitral regurgitation remains one of the most challenging conditions we treat because many patients have complex anatomy or underlying ventricular disease that can limit existing transcatheter repair options,” said Gagan Singh (University of California Davis Health, Sacramento, USA). “The Carlen system introduces a differentiated repair strategy that is intended to alleviate the limitations of current transcatheter approaches, addressing an important unmet clinical need and expanding the options available to physicians treating these patients. We are excited to be the first US centre participating in the ENHANCE early feasibility study and look forward to supporting the clinical evidence needed to evaluate this novel therapy.”
The ENHANCE early feasibility study is evaluating the safety and performance of the Carlen system in patients with symptomatic moderate-to-severe or severe FMR. The study is being conducted at leading structural heart centres in the USA and internationally. It is a prospective, multicentre, single-arm study with safety, performance and clinical endpoints following patients through five years.
“This enrolment represents more than the beginning of another clinical study,” said Lori Chmura, CEO of Nyra Medical. “It reflects the steady execution of our long-term strategy to redefine transcatheter mitral valve repair. We have assembled an exceptional team, partnered with leading structural heart physicians, and developed a differentiated technology designed to address a substantial unmet clinical need. We believe ENHANCE EFS positions Nyra for an exciting next phase of growth as we continue building the clinical evidence supporting the Carlen platform.”
In a press release, Nyra Medical recognised the contributions of Edwin Ho (Montefiore Medical Center, New York, USA), Azeem Latib (Montefiore Medical Center, New York, USA), and Susheel Kodali (New York Presbyterian Medical Center, New York, USA), in supporting the first cases, as well as clinical expertise and strategic guidance in shaping the clinical programme that has contributed to the milestone.
