News | July 09, 2012

Miracor Reports First-In-Man Results Using Its PICSO System to Treat AMI

Successful delivery of PICSO treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first three STEMI patients

July 9, 2012 — Miracor Medical Systems GmbH announced that the first three ST segment elevation myocardial infarction (STEMI) patients enrolled in its “Prepare RAMSES” nonrandomized safety and feasibility study of 40 patients have been successfully treated using PICSO (pressure-controlled intermittent coronary sinus occlusion) for 90 minutes following primary PCI (percutaneous coronary intervention, or angioplasty) of the left anterior descendens (LAD) coronary artery.

Principal investigator of the “Prepare RAMSES” study is Dr. Jan Piek at the Academic Medical Center, Amsterdam, Netherlands. This is the first time that PICSO has been used to treat acute heart attack STEMI patients following a coronary angioplasty. In a STEMI, the coronary artery is completely blocked off by the blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to die.

“We are very pleased with the initial outcomes in this population of acute coronary syndrome patients,” said Piek. “While there is a modest learning curve in order for clinicians to become facile with this new technology, we investigators are certain that the PICSO system can be used safely and immediately following PCI in acute coronary syndrome patients.”

“Even after a successful coronary angioplasty, inadequate myocardial reperfusion still occurs in about one in three STEMI patients, and this unacceptable incidence is notoriously linked to adverse outcomes for patients,” said Jon H. Hoem, Miracor CEO. “We are very pleased with these initial results for the ‘Prepare RAMSES’ study, which is expected to demonstrate that PICSO considerably amplifies the redistribution of blood into the blood-starved myocardium of severe heart attack patients, even post-PCI.”

The secondary endpoints of the “Prepare RAMSES” clinical study include enzyme release, 24-hour ECG (electrocardiograph) monitoring, echocardiography and MRI (magnetic resonance image) at discharge and four months follow-up examination.

The Miracor PICSO Impulse System is CE-marked and can be used during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. The technology is currently available for investigational use only in the United States.

For more information: www.miracormedical.com

Related Content

Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init