The technology described herein endeavours to address the symptoms of severe Tricuspid Regurgitation (TR) posed by a dysfunctional native tricuspid valve in the right heart. This is done by restoring unidirectional forward flow of blood within the right heart by percutaneously placing valve stent devices at both vena cava-atrial junctions to prevent backflow of blood out of the right atrium (RA). At present, there are no effective percutaneous treatment modalities available in the market for treating severe TR due to the complexity of the tricuspid valve apparatus. Thus, the percutaneous approach of deploying these valve stent devices at the vena cava-atrial junctions address two major critical unmet needs in the market relating to severe TR treatment. Firstly, the technology described circumvents the challenges of anchoring a valve stent device at the native tricuspid valve site due to the compliant nature of the tricuspid annulus. Secondly, it enables severe TR treatment to be brought to patients (with old-age or other co-morbidities) who are otherwise precluded from conventional surgical intervention (currently the gold standard treatment method) due to the high intraoperative morbidity risk of 22%.
The implants made from tri-leaflet tissue valve housed within a novel self-expanding stent frame coated with an impermeable biocompatible polymer. The proprietary catheter system specifically designed for the percutaneous delivery and deployment of the valve stent device at both vena cava-atrial junctions. Features and Specifications of the technology: Restores unidirectional flow of blood of the right heart and prevents regurgitant blood from the dysfunctional native tricuspid valve from leaving the RAduring systole. In-vitro testing done in a pulsatile flow loop set-up demonstrated that the treatment method was capable of restoring up to 92% of cardiac output (CO). In-vivo post-implantation diagnostics via cardiac angiography has demonstrated device patency and negligible backflow, thereby validating in-vitro data. Device self-alignment and secure anchorage at target site. Minimal to negligible device migration observed in in-vivo pre-clinical severe TR studies at 12-weeks follow-up validated in-vitro anchorage testing results. Self-expanding nature of the device allows it to adapt to the contours of the vena cava at the target site during the deployment process. Biocompatible coating lowersthe risk of thrombosis and foreign body response towards the device post implantation. This potentially allows for a less aggressive anti-coagulant and anti-platelet treatment regime. Ease of delivery and deployment. The compact low-profile delivery system requires a smaller entry site at the femoral venous vasculature. This has an added advantage of better entry wound management and reduced risk of vessel trauma.
The technology described herein can be employed primarily in the cardiovascular sector of the medical devices industry. Specifically, it can be marketed as a minimally invasive treatment modality for patients suffering from severe TR, which are currently precluded from surgical interventions due to high intraoperative morbidity risks. On a broader scale, devices that can be marketed using this technology include (but not limited to) cardiovascular stents, valve stent devices for the percutaneous treatment of valvular heart disease and peripheral vascular stents.
The current state of the art treatment modality for severe TR calls for a surgical intervention to address the dysfunctional tricuspid valve in the patient. Thus, many elderly patients and patients with co-morbidities that significantly increase the operative risk of the procedure are currently being precluded from surgery to treat severe TR. Such patients are instead currently treated with therapeutic drugs to alleviate and address the symptoms of severe TR. By restoring the unidirectional flow of blood within the RA, the severe TR treatment modality using percutaneous valve stent devices as proposed in this technology can serve as a potential alternative treatment approach by mitigating the symptoms associated with severe TR in cases in which the use of therapeutic drugs is no longer effective. With no percutaneous treatment method for tricuspid valve replacement currently available on the market, the proposed technology will allow interventional treatment to be brought to patients that were previously precluded from surgery. This minimally invasive approach would have the advantage of lowering risk and mortality rate as patients would not have to undergo open heart surgery. Therefore, the proposed technology presents itself as a potential alternative therapy for the elderly and/or frail severe TR patient population. Apart from a reduction in operative morbidity and mortality risks, shorter procedure, hospital stay and recovery times can potentially be achieved through the use of the percutaneous severe TR treatment therapy proposed in this technology. This would directly translate into overall medical cost reduction for both the patient and the hospital. When fully developed, the technology may also have the potential to cater to a more diverse severe TR patient population as compared to the current state of the art surgical intervention and/or therapeutic drug treatment methods.