InspireMD Hints At Positive Results From MGuard™ Stent Trial

In short

We’ve covered Israeli coronary stent expert, InspireMD, Inc., before on our pages, recently in May announcing completion of enrollment in its MASTER study into use of the company’s MGuard™ stent in heart attack  patients.

The company  has now announced that the multi-centre randomised trial demonstrated a positive outcome in treating patients suffering heart attacks when compared to commercially-approved bare metal or drug-eluting stents. It’s a nice way of squeezing some extra PR miles out of a clinical study, but it’s not even half the story because the press release contains not a single number to support its claim, in effect asking us to wait for October’s TCT meeting before we get some flesh on the bones.

Background

Approximately 3.2 million stenting procedures are expected to be performed worldwide in 2012, of which 850,000, or about 26 percent, will be for patients having heart attacks. Stents for heart attack patients are expected to represent $1.8 billion of stent sales, or nearly 30 percent of the $5.9 billion global stent market.

The MGuard™ embolic protection stent is a coronary stent integrated with a proprietary micronet technology. The micronet is designed to hold plaque and thrombus in place against the blocked artery’s wall, preventing debris from entering the bloodstream, rather like one of those nets does in a tunnel prone to rockfalls.

MGuard™ combines a coronary stent merged with an embolic protection specifically designed for acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that is integrated with the stent. The company says its design is designed to provide outstanding and lifelong embolic protection, without affecting deliverability.

Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC)

The study

The MASTER (MGuard forAcute ST Elevation Reperfusion) trial enrolled 433 patients in nine countries and was designed to evaluate the MGuard™ embolic protection stent compared to commercially-approved bare metal or drug-eluting stents in heart attack patients undergoing primary percutaneous coronary intervention (PCI).

Detailed results will be presented at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Miami (October 22-26, 2012).

Company comments

“We have reached a key milestone in the history of InspireMD,” said Ofir Paz, the Company’s chief executive officer. “We look forward to presenting detailed results of the MGuard™ MASTER trial at the TCT in October.”

Regulatory status

MGuard™ is CE Mark approved with plans for a U.S. FDA registration trial underway. Patient enrollment is expected to begin by year end.

Source: InspireMD, Inc., PR Newswire