heart pump article, page-7

not a bad point dma, the fact they have an established track record in the market and that they are US based companies would mean they have some sort of "good will" established. In the real world, that "connections" DO count.

However, they still have to satisfy the FDA's minimum requirements, and that will take some doing. eg. I would expect that they would go through the same stage where their patients are not allowed to be discharged immediately after the operation. This is the key hurdle VCR had to go through and caused a substantial delay in completing feasibility trials.