News | March 07, 2011

Pilot Study for ACS Revascularization System Completed

March 7, 2011 – A pilot study testing a system designed to improve acute coronary syndrome (ACS) revascularization has been successfully completed. The study looked at the Picso Impulse System, from Miraco Medical, which is used following primary percutaneous coronary intervention (PCI) to diminish ischemia.

The Prepare Picso pilot study of stable angina patients included 10 patients at the Academic Medical Center, Amsterdam, The Netherlands. The company is planning to initiate the pivotal RAMSES clinical trial of the system.

“For all 10 patients, we needed less than 15 minutes from femoral vein puncture to safely insertion of the Picso catheter into the coronary sinus,” said Jan Piek, M.D., principal investigator of the study. “Thus, Picso is simple to insert at a site that is very familiar to us. Also, the Picso catheter is easy to maneuver and is continuously stable during the PCI procedure. We were especially pleased to observe a notable reduction of ischemia as documented by the surface ECG ST-segment shift in several patients, clearly suggesting that Picso has a potential cardio-protective benefit. In summary, the findings in this pilot study are extremely encouraging as we now look forward to the broader RAMSES clinical study.”

Timely myocardial reperfusion using primary PCI remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Paradoxically, the process of restoring coronary blood flow can in itself exacerbate the myocardial injury. The system offers a new approach to improve microcirculatory flow, reduce myocardial injury and revitalize ischemic myocardium.

The device is CE-marked.

For more information: www.miracormedical.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Overlay Init