Demonstrating Value with Robust Clinical Trial Data
Interview with Miracor Medical CEO Olivier Delporte
When Miracor Medical CEO Olivier Delporte joined the company in 2016, he had one stipulation: they needed to conduct randomized clinical trials to demonstrate the value of its flagship product, the PiCSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) Impulse System, a novel treatment for acute myocardial infarction, more commonly known as a heart attack.
PiCSO is intended for use during percutaneous coronary intervention (PCI), a first-in-line procedure to treat heart attacks as a way to reduce infarct size, which Olivier says should lower mortality rates and lead to fewer hospitalizations due to heart failure.
Under Olivier’s guidance, Miracor is focused on building a strong evidence base for PiCSO and is pursuing an expansive randomized clinical trial program to demonstrate value for doctors, patients, and payers — by showing that PiCSO can reduce heart failure that can often occur after a heart attack.
“The standard of care [for heart attacks] today is still stenting. Stenting has helped these patients, but at the cost of heart failure hospitalization,” Olivier says.
The company is conducting clinical studies in Europe and plans to initiate a randomized controlled trial for FDA clearance in 2023.
In this episode of Medsider, Olivier talks about the importance of gathering robust clinical evidence in randomized clinical trials, how the company uses remote video monitoring to guide procedures, and why startups should raise the bar on their financial goals.
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