Competitors

Other than competing with current Edwards Lifesciences loaders, one other company claims to have a flushable loader

Oscor Logo Oscor is a German based biomedical company that focuses on developing various cardiac surgical tools, specifically lead systems for pacers. And the device that is comparable to the Biostein's design is called the Breezeway II.



The Flushable Loader TM follows design criteria and testing specifically for the Edwards Lifesciences TAVR delivery system. And while both the Oscor Breezeway II and the Biostein's Flushable Loader TM attempt to make flsuhing easier, Biosteins puts emphasis on the ease of use for the technicians by making a shorter sized loader. This ensures the least amount of force is required to actually flush the valve before entering the artery. It is also important to note that the Oscor loader has a seperate attachment to the sheath which requires more time for the technician and adds an unecessary port for air to enter.

Altough both devices may act according to their own criteria, the usability of the Biostein design is quicker and easier to flush. This is due to the addition of the shower head design that is implented, creating a vortex flow profile, something the Oscor loader does not claim to have.

Market Potential

There is a large market for this kind of device, proving the need for constant improvision of current options.

According to the Frankel Cardiovascular Center, up to 300,000 people in the U.S. are diagnosed with aortic stenosis a year. And as a person ages the risk for heart disease increases to roughly 75% probability. Meaning, there is a major need for constant improvemnts in the heart surgery department, namely, the TAVR (transcetheter aortic valve replacement) surgery. Therefore, the market for flushable loaders which makes the procedure a smoother experience for the technicians will grow as the number of people aquiring this procedure continues to grow.

Projected Market Growth

Global TAVR Project Growth

The TAVR market is an expanding field with a projected increase from 3.62 billion USD to 8.47 billion USD from 2022 to 2027 respectively according to Market Data Forecast.

This further shows the need for continuous research and development in an serious surgery that millions of individuals around the world need. In addition, it will be a field of biomedical engineering that will stay funded, opening the door to more innovations in the furture.