The device is for direct thrombolysis in patients with pulmonary embolism and as is the case with many devices, the evidence-base is challenging and not well understood. We are carrying out a gap analysis which involves  a systematic literature review to identify all the existing evidence, reviewing the evidence and then deciding what is missing and how any missing data might be generated.  We will then use our findings to make an assessment of the potential for the evidence to support European approval and a market access strategy for the product.