A CD&D Staff Report
InspireMD (Tel Aviv, Israel) reported that it has launched the MGuard Coronary Stent in Italy. MGuard received CE-mark approval in October to treat patients with coronary artery diseases. Distribution of MGuard in Italy will be carried out by InspireMD's Italian distributor, Kardia (Milan).
The MGuard coronary stent presents a combination of a coronary stent merged with an embolic protection device. The embolic protection device is comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent. The protective sleeve is designed for utmost flexibility while retaining strength characteristics of the fiber material.
The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post-procedure.
With the launch in Italy, MGuard was implanted in a procedure broadcast live to the more than 1,500 attendees on the opening day of the JIM conference in Rome. The patient was a 71-year-old male suffering from hypertension, the procedure performed by Dr. Ralf M ller at the Helios Heart Center (Siegburg, Germany).
The company said that the MGuard is designed to provide an embolic shower protection during and post stenting procedure and that in ongoing clinical trials in Germany and Brazil, the stent has a procedural success rate of 100%, with no major adverse cardiac events.
On the second day of JIM, Antonio Colombo, MD, jointly with Jeffrey Moses, MD, treated a 76-year-old male patient with progressive infarct myocardium angina at San Raphael Hospital (Milan). MGuard was delivered in what the company termed "an extremely complex procedure" involving six different lesions and total of seven drug-eluting stents deployed.
"MGuard represents a very clever approach to embolization control," Colombo said, "Its safety profile, coupled with the embolic protection during and post-procedure, position MGuard as an important addition to the arsenal of the interventional cardiologist in treating embolization-prone lesions."