Miracor Medical Systems out of Vienna, Austria has announced that its Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse System has received the European CE mark. Miracor claims the PICSO system is a superior alternative to a coronary stent implantation alone (aka Percutaneous Coronary Intervention or PCI) for treatment of coronary artery disease in some patients. While PCI can successfully restore blood flow through occluded arteries, it is well known that more than half of PCI patients experience suboptimal flow through treated arterial bed immediately following implantation, a phenomenon known as myocardial blush, and over 25% of patients continue to display suboptimal myocardial blood flow many months after a procedure. The PICSO system works by occluding the venous side of the cardiac circulation, via an intermittent block at the coronary sinus, which Miracor claims will result in increased upstream pressure, and therefore greater blood redistribution through the ischemic area. The biggest problem with such a system, in our opinion, is how to access the coronary sinus in a quick and efficient manner, since getting there is often a tricky and often lengthy process even with the best of hands.
From the product page:
During a heart attack one or several arteries are blocked due to a build-up of plaque in the coronary vessel. This will limit the flow to the heart tissue thereby destroying the tissue shown as white in this figure.
The flow can be restored using a stent or another method to open the artery. This restored flow is effective to improve the cardiac function after a heart attack. However, not all of the damaged myocardium is revitalized as mentioned in the description above. In addition, the opening of the artery itself can cause damage to the tissue.
The Miracor PICSO® Impulse Catheter is inserted on the venous side of the heart and intermittently inflated to increase the pressure in the myocardium. This pressure build-up causes a redistribution of flow into the damaged area and it is our hope that it will improve myocardial perfusion and cardiac function after PCI.
PICSO product info video:
Press release: Miracor receives CE-mark for its PICSO® Impulse System…
Product page: The PICSO® technology…