Researchers have indicated that an enzyme found in coronary plaques may be responsible for significant number of cardiac patients suffering from heart attacks and stroke, despite the widespread use of cholesterol-lowering drugs. The enzyme makes plaque more vulnerable to rupture and block blood flow. According to new research, the drug darapladib, taken in adjunct to the treatment of statin drugs, may offer a way to fight that risk as it safely and effectively lowers the activity of the Lp-PLA2 enzyme.

Photo by Patrick J. Lynch

 CorMatrix Cardiovascular Inc. has received 510(k) clearance from the FDA for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company’s proprietary ECM Technology(TM). The company’s platform ECM Technology provides a natural bioscaffold that enables a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM, which is currently cleared for the reconstruction and repair of the pericardium, can now be used for suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.

InfraReDx has received FDA clearance for its InfraReDx LipiScan catheter imaging system used to see inside a blood vessel to assess the fat content of plaque that builds up on coronary artery walls. The device uses infrared imaging to determine how much fat and other substances are in the plaque on arterial walls by measuring light reflected back from the walls of an artery into which a catheter with a fiber-optic laser was inserted. The device is cleared for physicians who evaluate patients with coronary heart disease symptoms during a heart test known as cardiac angiography.

Abiomed Inc. has received a positive national coverage determination from the Centers for Medicare & Medicaid Services (CMS) that allows coverage of the AbioCor Total Replacement Heart. The AbioCor implantable replacement heart is designed to extend the lives of patients who would otherwise die of heart failure. AbioCor can potentially offer an improved quality of life as a patient can be mobile and a productive lifestyle.