Project: Optimal Clinical Occlusion Catheter for applying Pressure-controlled intermittent coronary sinus occlusion (PICSO) therapy.

Myocard infarction is treated with pharmacological therapy (lysis) or the gold standard procedure of Percutaneous Coronary Intervention (PCI). 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.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. In addition, the opening of the artery itself can cause damage to the tissue._x000D_Miracor has developed within the last years from its inception a new technology to improve the perfusion of ischemic myocardial tissue. _x000D_PICSO® (pressure-controlled intermittent coronary sinus occlusion)consists of a console and the disposable single use Miracor PICSO® Impulse Catheter. The Miracor PICSO® Impulse Catheter is introduced into the coronary sinus either from the femoral or jugular vein. The placement of the catheter is facilitated using a commercially available coronary sinus guide sheath. The guide sheath is advanced into the right atrium and to the coronary sinus opening. When in position the Impulse Catheter in advanced through the sheath and into the central portion of the coronary sinus. The proper position of the catheter is verified angiographically by the two marker bands on the catheter. After the verification the guide sheath is withdrawn into the right atrium where it reCOs for support.The PICSO® principle is based on the fact that the pressure in the coronary sinus will increase when the vessel is occluded. During the occlusion the pressure will rise from the normal right atrial pressure to a pressure plateau which is different from patient to patient. Using the current PTCA balloon or a coronary stent (PCI) a majority of the coronaries will be opened. The TIMI 3 flow will be achieved in more than 90% of the patients undergoing coronary revascularization according to a study in high risk patients by Stone et al. However, the flow through the reopened artery does not immediately impact the damaged myocardium. The same study found that in only 29% of the patients optimal myocardial flow was achieved measured by myocardial blush. Myocardial blush is directly related to the outcome of patients undergoing coronary revascularization. Another study by Hoffmann et al. found that 49% of the patients undergoing PCI achieved optimal myocardial blush immediately after PCI. This success rate changed to 73% after 7 ½ months. The patients without optimal tissue perfusion constitute a large patient group at charge and at follow-up after PCI. These patients have poorer outcomes with increased risk of heart failure than patients with optimal outcomes.PICSO® aims to improve the myocardial perfusion after PCI by redistributing flow into the damaged tissue immediately following PCI. Miracor medical systems is an Austrian medical device company dedicated to develop and commercialize the PICSO® technology. Miracor was founded by Professor Werner Mohl and the European venture capital firms Earlybird and Delta Ps. _x000D_For more than 15 years Bavaria Medizin Technologie (BMT) specialized in designing, developing and manufacturing different types of catheters. At the same time, BMT is also a contract developer for medical device companies from all over the world. _x000D_After successful use of the Miracor Catheter Technology on animal studies, early human clinical tests have shown that the current catheter design is not optimal. Catheter Push-out during PICSO therapy, kinking of the catheter during pressure buildup are several problems the current design suffers from._x000D_The extra support catheter stiffer tip design is a goal, where the Ps need to improve on the dynamic as well as static behavior of the catheter in humans._x000D_It is mandatory that the catheter gets improved stability and behavior since therapy as well as clinical safety is at stake. Additionally first clinical results show that the PICSO®therapy needs above improvements before a true clinical treatment is feasible. Innovation and research on the catheter will be in material research, tip design and dynamic behavior, coronary sinus pressure buildup resistance as well as balloon size and pressure value – force interaction between the Balloon material and the Coronary Sinus Tissue. With innovative technology, the Ps can research the possibility and mechanical construction of Fiber Optic Pressure sensing technology to decrease the lumens for pressure sensing to an absolute minimum. Here progress towards an outer lumen diameter of +/- 5F, which is currently a preferred size of catheter diameter in cardiology is necessary, because it is less problematic than the bigger diameters. In addition we like to research the possibility to add RFID to the catheter. It will improve the handling and increases the safety of the procedure.

Acronym	COP-CATHETER (Reference Number: 8400)
Duration	01/10/2013 - 30/09/2016
Project Topic	Within the proposed project a catheter for the Pressure-controlled Intermittent Coronary Sinus Occlusion will be developed, which will improve the therapy of patients with myocardial infarction by optimizing the perfusion of the ischemic myocardial tissue after Percutaneous Coronary Intervention.
Network	Eurostars
Call	Eurostars Cut-Off 10

Project partner

Number	Name	Role	Country
2	Bavaria Medizin Technologie GmbH	Partner	Germany
2	Miracor Medical Systems GmbH	Coordinator	Austria