Boston Scientific Corp has received approval from the FDA to market its new WallFlex Biliary RX covered stents. The stents are designed to treat clogged bile ducts in cancer patients. The liver excretes bile, which the body uses to help digest food. The WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006. The new covered version of the stents was also approved by European regulators.

The FDA approves Boehringer Ingelheim’s MICARDIS® (telmisartan) as the first treatment in its class to reduce the risk of heart attack, stroke, or death from cardiovascular causes in patients at high cardiovascular risk who are unable to take ACE inhibitors. This new indication is based on The ONTARGET Trial results which showed that MICARDIS® may prevent one in five serious CV events or death from cardiac causes.

The FDA announced that roughly 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable. Although there have been reports of the memory chips in some of the defibrillators failing during routine self tests, none of them have failed during emergencies and caused patient injuries or deaths.

The FDA has cleared the way for St Jude Medical Inc to launch its new EnSite velocity Cardiac Mapping System. The new system has been designed to help doctors diagnose and guide therapy to treat abnormal heart rhythms. The system, used in minimally invasive electrophysiology procedures, uses catheters with electrodes inserted into a cardiac chamber. The electrodes then relay electrical information from the heart in a 3-D anatomical model.

The Johnson & Johnson subsidiary, Cordis, wins a nod from the FDA for its 2.25mm Cypher drug-eluting stent for treating blockages in small blood vessels. The company said data from the RESEARCH and T-SEARCH studies indicated that patients treated with the small Cypher model had a 65% lower incidence of death or heart attack than patients treated with the 2.25mm Boston Scientific device.

The FDA has sent letters to physicians declaring a Class 1 recall of the Sutureless Connector intrathecal catheter made by Medtronic Inc. The device might be incorrectly labeled as compatible with the IsoMed Pump Model 8472, a drug pump Medtronic discontinued last year as part of what it calls a “planned product phase-out.” The catheter models 8709SC, 8731SC, 8578, and 8596SC are affected by the recall. Even though the catheter appears to fit the pump, the connection is not secure, which can cause drugs or cerebrospinal fluid to leak out, resulting in drug overdose, tissue damage and so-called spinal headaches.

Solvay’s and Abbott’s TriLipix TM (fenofibric acid delayed-release capsules) was approved by the FDA for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TriLipixTM is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels. TriLipix has not been shown to prevent heart disease or heart attack.

The advisory panel for the FDA has backed a new type of heart valve that can be implanted without the open heart surgery required for traditional valves. Medtronic Inc’s Melody heart valve has been recommended for approval for the group of people born with cardiac defects that impede blood flow from the right ventricle to the pulmonary artery. The device can be implanted by threading a tube through a leg vein to the heart.

Panel recommends Melody Transcatheter Pulmonary Valve
The FDA’s Circulatory System Devices Panel has unanimously recommended the approval of Humanitarian Device Exemption of Medtronic’s Melody Transcatheter Pulmonary Valve. The device is designed for patients with congenital heart defects, status post open heart surgery, who developed right ventricular outflow tract (RVOT) obstruction. The Melody Transcatheter Pulmonary Valve is the first transcatheter heart valve to be approved for commercial use anywhere in the world and the first to be reviewed by an FDA panel.

St. Jude Medical Inc has received approval from the US Food and Drug Administration (FDA) for a pair of wireless-ready pacemakers called the Accent RF pacemaker and Anthem RF CRT-P (for cardiac resynchronization therapy pacemakers). These pacemakers can wirelessly communicate with a programmer used by the clinician or a home monitor.