The MGuard Coronary Clinical Trials

The First in Man trial of the MGuard Coronary stent system, showed the following six months results:

Protocol is being amended to obtain long term (> 1y) results.

Long term clinical results expected by May 2009

Ongoing Clinical Trials 
Several other trials are ongoing.

• GUARD Trial is being conducted in Brazil and involves 60 patients with SVG or native coronary lesions.
  Six months angiographic and IVUS follow-up as well as 1 year clinical follow-up is planned..Enrollment is still ongoing. Final results are expected in December 2009
  
  
• MAGICAL Trial is being conducted in Poland and involves 60 patients with STEMI indication.
  There is a six months clinical follow-up and the key endpoints are ST resolution at 60 min. post procedure, TIMI 3 flow and Myocardial Blush grade. Enrollment is still ongoing. Final results are expected in May 2009
  
  
• The iMOS (international MGuard observational study) Registry is being launched in Europe during the first quarter of 2009. This registry will enroll 1000 patients in 50 centers around the world. The iMOS objective is to establish the MGuard performance in a ‘real world' population. Patients will be followed for 1 year. Acute results are expected in October 2009.

 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.