The Pivot Mandu is an innovative device featuring a leak-tight adjustable 3D balloon spacer, incorporating inner mesh support, an outer e-PTFE layer, and a compliant balloon in the middle layer with a specialized detachable system. To assess its feasibility, proof of concept was rigorously evaluated through bench testing and survival porcine animal experiments. The results demonstrated successful remote inflation of the balloon system, with the balloon spacer exhibiting sustained patent and functional integrity over an extended observation period of up to 6 months. A noteworthy feature of the newly designed 3D balloon spacer is its capability for easy size adjustment during procedures, enhancing its adaptability and practicality in clinical settings. This three-layered 3D balloon spacer, with its established long-term patency, exhibits highly encouraging outcomes that hold promise in overcoming the current limitations of spacer devices for heart valve diseases. Given the compelling results from preclinical investigations, the translation of the Pivot Mandu into human trials is strongly warranted.

Background: Current treatments for hypertrophic obstructive cardiomyopathy (HOCM), including medication, surgery, and alcohol septal ablation (ASA), have limitations in terms of efficacy and safety. To address these challenges, we developed the trans-coronary intra-septal radiofrequency ablation (TIRA) device. Methods: This first-in-human trial was conducted to assess the efficacy and safety of the TIRA device. Moreover, evaluations were conducted before the procedure and at 3, 6, and 12 months post-procedure using computed tomography, magnetic resonance imaging, echocardiography, and the 6 min walk distance (6MWD) test. Results: Four patients were enrolled, and follow-up imaging at 3, 6, and 12 months showed a reduction in the interventricular septal (IVS) thickness (baseline mean: 22.6 mm; 12-month mean: 18.9 mm) and a decrease in the LVOT pressure gradient at 12 months (resting baseline mean: 84.64 mmHg; resting 12-month mean: 43.56 mmHg; Valsalva baseline mean: 129.96 mmHg; Valsalva 12-month mean: 108.16 mmHg). However, reductions in the IVS thickness on echocardiography and improvements in 6MWD were observed in only two patients. Conclusions: No significant adverse events, such as arrhythmias or vascular injuries, were reported. These findings suggest that the TIRA device may be a safe and effective option for treating HOCM. However, further studies are required to confirm these results.

Tricuspid regurgitation (TR) resulting from valve abnormalities necessitates precise diagnostic tools and interventions. We employed a simulated heart movement device to examine the performance of heart valve functions and analyzed internal pressure changes to provide a quantitative guide for TR treatment. We developed a simulator capable of replicating the flow profile, mimicking natural heart movements, with sensors installed for measuring internal pressure changes. We conducted an ex vivo experiment on a porcine heart to assess tricuspid valve functionality. An endoscope was installed, with a sensor and endoscopic images to detect abnormalities. TR became evident when the heart rate spectrum exceeded an average of 85.2 bpm (standard deviation, 1.3 bpm) and showed an amplitude higher than an average of 12.3 mmHg (standard deviation, 3.2 mmHg). This critical threshold consistently indicated TR onset. The application of the Pivot-TR attenuated this specific spectral area. We confirmed TR disappearance by reducing the intensity of the Tricuspid Regurgitation Generator or employing the Pivot-TR. The Pivot-TR’s ability to attenuate specific spectral areas associated with TR onset and its effectiveness in restoring normal heart functionality has implications for managing and treating TR, particularly that resulting from age-related structural changes in the heart.