Periodic Reporting for period 2 - V-sling (Transcatheter Ventricular Repair Device for treatment of Heart Failure Patients)
Reporting period: 2023-05-01 to 2024-04-30
Heart failure (HF) represents a major public health concern, affecting around 13M people worldwide. A major risk factor for HF is a myocardial infarction, which causes ventricular remodelling, during which the ventricle enlarges, making the heart even less effective at
pumping blood, and results in displacement of the papillary muscle. Progressive papillary muscle displacement leads to severe Functional Mitral Regurgitation in about 20% of the patients, the only ones currently receiving treatment because of the severity of the condition. The remaining 80% of patients don’t experience severe FMR and are not considered for surgery: they will remain symptomatic or deteriorate despite Guideline-directed medical therapy. As these patients, who are not yet end-stage and indicated for a durable left ventricular assist device or heart transplant, they will continue to suffer, and likely die since there is no are no approved device-based treatments available. Cardiac Success develops the V-sling system, a transcatheter ventricular repair device to improve cardiac function in HF patients. The objectives of the project are to finalize product optimization, complete V&V and pre-clinical testing, and perform the FIH study.
pumping blood, and results in displacement of the papillary muscle. Progressive papillary muscle displacement leads to severe Functional Mitral Regurgitation in about 20% of the patients, the only ones currently receiving treatment because of the severity of the condition. The remaining 80% of patients don’t experience severe FMR and are not considered for surgery: they will remain symptomatic or deteriorate despite Guideline-directed medical therapy. As these patients, who are not yet end-stage and indicated for a durable left ventricular assist device or heart transplant, they will continue to suffer, and likely die since there is no are no approved device-based treatments available. Cardiac Success develops the V-sling system, a transcatheter ventricular repair device to improve cardiac function in HF patients. The objectives of the project are to finalize product optimization, complete V&V and pre-clinical testing, and perform the FIH study.
1. Design Optimization and Finalization: The company has successfully optimized and finalized the design of the Vsling implant and the Vsling catheter delivery system. This indicates that the development process has progressed to a stage where the product design has been refined and is considered ready for further testing and implementation (RP 1).
2. Verification and Validation (V&V) Testing: A comprehensive verification and validation testing plan has been completed. V&V testing is crucial for ensuring that the product meets the required specifications and performs as intended. The completion of this testing plan suggests that the Vsling implant and catheter delivery system have undergone rigorous assessments and have demonstrated satisfactory performance (RP 1).
3. Pre-Clinical Testing: The company has conducted pre-clinical testing, including chronic in-vivo testing, as part of the evaluation process. Pre-clinical testing involves assessing the safety and efficacy of the Vsling device in animal models, providing valuable insights into its long-term effects and functionality. This crucial step has allowed the company to gather important data and ensure the device's performance before advancing to human trials (RP 1).
4. First In Human Clinical Trial: The Vsling device has entered its first in human clinical trial (FIH) in Georgia and Israel, marking a major milestone in its development. FIH trials involve the initial testing of the product on human subjects, primarily focusing on assessing its safety and effectiveness. In this trial, a small number of patients have been treated with the Vsling device, and the interim results are encouraging. The patients have shown improvements in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and in physical performance as measured by the six-minute walk tests. These positive outcomes suggest that the Vsling device has the potential to enhance patients' well-being and physical capabilities.
5. Design and Procedural Optimization: Refinements to the Vsling procedural planning, delivery system, and implant design are underway to enhance device usability and procedure efficiency. All changes are rigorously tested under relevant standards and protocols to ensure the device meets required specifications and performs as intended.
6. Procedure Training: Newly developed in-house simulators, which integrate both fluoroscopy and echo imaging guidance, are being used to provide operators with patient-specific procedure training.
2. Verification and Validation (V&V) Testing: A comprehensive verification and validation testing plan has been completed. V&V testing is crucial for ensuring that the product meets the required specifications and performs as intended. The completion of this testing plan suggests that the Vsling implant and catheter delivery system have undergone rigorous assessments and have demonstrated satisfactory performance (RP 1).
3. Pre-Clinical Testing: The company has conducted pre-clinical testing, including chronic in-vivo testing, as part of the evaluation process. Pre-clinical testing involves assessing the safety and efficacy of the Vsling device in animal models, providing valuable insights into its long-term effects and functionality. This crucial step has allowed the company to gather important data and ensure the device's performance before advancing to human trials (RP 1).
4. First In Human Clinical Trial: The Vsling device has entered its first in human clinical trial (FIH) in Georgia and Israel, marking a major milestone in its development. FIH trials involve the initial testing of the product on human subjects, primarily focusing on assessing its safety and effectiveness. In this trial, a small number of patients have been treated with the Vsling device, and the interim results are encouraging. The patients have shown improvements in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and in physical performance as measured by the six-minute walk tests. These positive outcomes suggest that the Vsling device has the potential to enhance patients' well-being and physical capabilities.
5. Design and Procedural Optimization: Refinements to the Vsling procedural planning, delivery system, and implant design are underway to enhance device usability and procedure efficiency. All changes are rigorously tested under relevant standards and protocols to ensure the device meets required specifications and performs as intended.
6. Procedure Training: Newly developed in-house simulators, which integrate both fluoroscopy and echo imaging guidance, are being used to provide operators with patient-specific procedure training.
The Vsling device, still in the investigational stage, has been implanted in a small number of patients with up to 18 months follow-up . Despite this limited duration of observation, the interim report has provided encouraging results. The company has received highly positive responses from physicians, industry experts, and key opinion leaders. This positive feedback reflects the potential value and effectiveness of the Vsling device in addressing the unmet needs of heart failure patients.
To further evaluate the device and expand its reach, the company is expanding the clinical trial sites to include Israel, Lithuania, Czech Republic and Poland. This expansion indicates the company's commitment to conducting thorough clinical trials in different locations, potentially enhancing the diversity of patient populations and contributing to the generalizability of the results. Active recruitment of heart failure patients for the Vsling FIH study is ongoing, demonstrating the company's dedication to gathering additional data and evidence regarding the device's potential benefits.
Moreover, the Vsling technology has gained recognition in the scientific community. It has been referenced in scientific journals and has been featured at various scientific conferences. This acknowledgment demonstrates the growing interest and acceptance of the Vsling technology within the medical and research communities.
To further evaluate the device and expand its reach, the company is expanding the clinical trial sites to include Israel, Lithuania, Czech Republic and Poland. This expansion indicates the company's commitment to conducting thorough clinical trials in different locations, potentially enhancing the diversity of patient populations and contributing to the generalizability of the results. Active recruitment of heart failure patients for the Vsling FIH study is ongoing, demonstrating the company's dedication to gathering additional data and evidence regarding the device's potential benefits.
Moreover, the Vsling technology has gained recognition in the scientific community. It has been referenced in scientific journals and has been featured at various scientific conferences. This acknowledgment demonstrates the growing interest and acceptance of the Vsling technology within the medical and research communities.