OBJECTIVES Regulatory hurdles for novel medical devices are lower in Europe than in the US. The costs and evidence requirements to achieve CE marking for class III devices are lower than to achieve FDA-approval via a PMA submission. As such, many companies have chosen to enter European markets with innovative cardiac devices before entering the US market.  This study sought to understand the frequency with which that has occurred in the last 10 years, and the correlation between market access timing and cardiac outcomes.  METHODS A review of CE mark and FDA approvals for class III implantable cardiac devices was conducted for the period of 2003-2013.  Devices were identified and cross referenced to determine which products achieved both CE mark and FDA approval.  Those with both, were then compared by the date of approval to determine market access variance in the US versus Germany.  Publically available coverage and reimbursement policies were reviewed in each market in combination with relevant disease prevalence rates over the study period. RESULTS Implantable cardiac devices were routinely available in Germany before the US during the study period.  Early use across Europe, in many cases, created additional evidence that was leveraged during the FDA approval and follow-on reimbursement assessment processes in the US.   While HTAs for devices was relatively rare in Germany, similar rates of reimbursement and access were achieved in both markets.  Rates of cardiovascular associated mortality have dropped dramatically, across both markets though rates initiated their decline earlier in Germany. CONCLUSIONS Germans benefited from earlier access to many innovative implantable cardiac devices during the period of 2003 to 2013, as compared to their American counterparts.  The link between early access, clinical outcomes, and cost needs to be further analyzed in future studies.