Dive Brief:

• FDA has granted breakthrough device status to Belgian company Miracor Medical’s treatment for ST-elevated myocardial infarction patients, the company said Thursday.

• The device, the PiCSO Impulse System, is designed to increase blood flow to the affected part of the heart, thereby preventing tissue death and improving patient outcomes.  

• Miracor recently began a 144-patient clinical trial in Europe to compare the effectiveness of its device to conventional percutaneous coronary intervention alone.

Dive Insight:

The concept of pressure-controlled intermittent coronary sinus occlusion, abbreviated to PICSO, has been around since the 1980s. PICSO entails placing a device in the coronary sinus to intermittently obstruct blood flow. Through the interference, PICSO may increase blood flow to parts of the heart affected by the myocardial infarction.

Miracor, which received a CE mark for its PiCSO system in 2010, built on the idea by developing an algorithm to calculate how long to block venous drainage via the coronary sinus.

The breakthrough device designation marks a step forward in Miracor’s efforts to bring the product to the U.S. market. Under the breakthrough program, Miracor stands to benefit from more frequent interactions with FDA and, if it makes it to the filing stage, an expedited regulatory review.

Miracor is still building out the evidence in support of its device. A first-in-human trial published in 2012 showed problems, mainly initial calibration difficulties, prevented the use of its system in one-third of the enrolled patients. 

A subsequent study was stopped “due to slow enrollment and a relatively high rate of unsuccessful PiCSO procedures.” Again, around one-third of patients were unable to undergo the procedure for a variety of reasons. Among the 19 patients who did receive the treatment, infarct size and myocardial recovery were not significantly better than among a historical control group.

Miracor recently started a larger clinical trial that is randomizing patients to either receive its system or standard percutaneous coronary intervention. The trial is designed to show whether using the device in addition to PCI reduces infarct size at five days compared to PCI alone.

If Miracor succeeds in bringing the device to the U.S. it stands to benefit from a recent change to how the breakthrough status influences reimbursement. Under a recently finalized rule, CMS will apply a different set of criteria to its assessment of breakthrough devices used in inpatient settings.