Aortic valve stenosis is a heart condition characterized by the narrowing of the aortic valve opening, which obstructs the flow of blood from the heart’s left ventricle to the aorta and subsequently to the rest of the body. This narrowing is often caused by the build-up of calcium deposits on the valve leaflets, leading to reduced blood flow and increased pressure in the heart.
At least 5% of the global population over 65 y.o. and 10-15% of the population over 75 y.o. suffer from aortic heart disease. Aortic stenosis symptoms may include chest pain, shortness of breath, fatigue, and fainting. Severe cases can lead to complications including heart failure and arrhythmias, requiring medical intervention such as valve replacement or other treatments to manage the condition.
TRANSCATHETER AORTIC VALVE
IMPLANTATION / REPLACEMENT
(TAVI / TAVR)
Interventional treatment of valve diseases
Surgical repair and aortic valve replacement (SAVR) has been the standard therapy for low- and moderate-risk patients with aortic stenosis for several decades. Such a procedure usually requires highly-invasive open heart surgery, with a long recovery and rehabilitation period. In contrast, for high-risk patients (usually older with concomitant diseases), transcatheter aortic valve implantation or replacement (TAVI or TAVR – two terms pertaining to the same topic) is recommended – a percutaneous, minimally invasive procedure, with a very short recovery time.
TAVI
Steady technological advances, procedural technique, patient selection, periprocedural management and operator experience have all contributed to a dynamic growth in the number of TAVI procedures performed globally. TAVI was initially restricted to patients with severe symptomatic aortic stenosis deemed at prohibitive risk for surgical aortic valve replacement. However, one randomized trial at a time, TAVI has shown its efficacy in high-, intermediate- and, recently, low-risk patients with severe degenerative aortic stenosis. Nevertheless, currently available TAVI systems have severe limitations.
Clinical problems to be solved
Current TAVI systems are mostly restricted to older patients (>75 y.o.) due to the degeneration of biological valve leaflets – their durability rarely exceeds 10 years after implantation. TAVI procedures are expensive due to the high prices of the valves available on the market, which are a result of costly and time-consuming manufacturing processes. TAVI implantation is a relatively complex procedure, requiring extensive training and a high skill level of the operating physician (interventional cardiologist or cardiac surgeon). These factors have hindered the expansion of TAVI technology, limiting it mostly to elderly patients.
- Ageing population with rising prevalence of aortic heart valve disease: 17% in population >70 y.o.
- TAVI not available for younger patients <75 y.o.
- Limited durability of currently available TAVI systems
- High price of TAVI systems
- Ineligibility of many patients for SAVR due to high perioperative risk
- Limited availability of biological material; costly and time consuming manufacturing process
- Long waiting time for the procedure, with a significant number of patients dying while on the waiting lists
The InFlow Valve
The InFlow TAVI system offers an answer to urgent clinical needs, through the use of patent-protected technology. Our unique solutions, proven in a preclinical setting, include genetically-modified pericardium for the biological variant of the InFlow valve, polymer-based electro-spun material for the polymeric InFlow valve as well as a self-positioning, easy-to-use delivery system. These advances will allow for the implantation of our InFlow valve in younger patients (due to high durability of our material) and will lead to an increase in TAVI procedure availability to a larger patient population (due to reduced costs and easier implantation of the InFlow valve).