The MGuard Coronary

The First in Man trial showed the following results: TLR rate of 6.6%, MACE 6.6% and Late Loss of 0.38 mm. To date, safety and efficacy of MGuard in man has been established.

Ongoing Clinical Trials 
Several MGuard™ trials are ongoing. Among them: MAGICAL Trial (MGuard™ in SVG and Native Coronaries Trial) is being conducted in Brazil and the GUARD Trial (MGuard™ in Acute Myocardial Infarction Study) in Poland.  Six months angiographic follow-up has started and enrollment is ongoing. First in Man (FIM)was conducted between October 2006 and February 2008. 41 high risk patients were enrolled and all of them have completed their 6 months follow-up period. 100% of patients experienced device success during the procedure.

Preclinical Studies
Coronary porcine studies conducted at MIT- Harvard have established the safety profile of MGuard™.  These trials demonstrated good feasibility and absence of safety issues like device thrombosis, animal morbidity, excessive inflammation and neointimal hyperplasia. Histology and histomorphometric d ata from the MGuard™ stented segments suggest that MGuard™ exhibited low Schwartz injury scores (0.15 ± 0.23), 76% lower than the BMS stented segment. MGuard™ also yielded exceptionally good endothelization (4 ± 0), low adventitial fibrosis (0.27 ± 0.28), acceptable inflammatory response (0.87± 0.45 on a scale of 0-3), absence of fibrin score (0 on a scale of 0-3), and absence of medical necrosis, mineralization, neovascularization or granuloma response. The extent of intimal hyperplasia was very acceptable (average neointima thickness 320 micron ± 6 0)

These studies concluded that MGuard™ can be safely delivered with conventional PCI equipment. Thrombosis, animal morbidity or mortality were not observed with the device. The injury score of MGuard™ was significantly lower than Bare Metal Stents. The extent of inflammation, endothelization, and intimal hyperplasia were similar or better than Bare Metal Stents.

CE Mark: 
MGuard Coronary Stent has CE Mark approval to treat patients with coronary artery diseases and is sold across Europe, South America and Asia.

MGuard is not available for sale in the United States

Selected Case Reports and Videos

Click here to watch interviews with leading interventional cardiologists regarding their experience with MGuard in Acute MI, SVG and  Native Coronaries.

The information provided is only for use in countries with the necessary applicable health authority product registrations.