Stenting has become routine when dealing with clogged arteries, but the process itself can dislodge plaque and cause dangerous embolisms further down the stream. This is because stents typically have large openings when expanded, and the compressed plaque can seep between the trusts of the stent to enter the bloodstream.
InspireMD, a Tel Aviv, Israel firm, has been trialing its MGuard Embolic Protection Stent (EPS) that was developed to help prevent plaque from dislodging and traveling away from the treatment site. In many ways much like many other stents, the unique feature of MGuard is a mesh sleeve that surrounds the outside of the device and keeps the plaque pressed against the arterial wall.
Here’s some details from the latest clinical trial of the MGuard, according to InspireMD:
The MASTER trial [MGuard for Acute ST Elevation Reperfusion] achieved its primary endpoint (p value = 0.008), in complete ST-segment resolution at 60-90 min post-procedure (a strong predictor of mortality). Secondary endpoint clinical outcomes continue to show a lower mortality rate with MGuard EPS compared to control (0.5% vs. 2.8%, P=0.06) at 6 months. These findings corroborate the previously announced 30-day results showing that all-cause mortality with MGuard EPS was lower than bare metal and drug eluting stents used as a control (0% vs. 1.9%, P=0.06). Additional 6-month results are available at http://www.inspiremd.com.
“The initial MASTER trial results published in the Journal of the American College of Cardiology in October 2012demonstrated the acute benefits of the embolic protection stent, as MGuard EPS outperformed drug-eluting and bare metal stents in complete ST-segment resolution,” said Professor Dr. Sigmund Silber , Director of the Heart Center at the Isar Academic Teaching Site of the University of Munich. “The six-month MASTER results highlight the enduring benefits of the MGuard EPS, with a consistent trend in lower mortality.”
In the MASTER trial, a total of 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention were randomized at 50 sites in 9 countries to the MGuard EPS (n = 217) or commercially available bare metal or drug-eluting stents (n = 216).