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.

Zoll Medical Corp received the FDA marketing approval for a new model of its LifeVest wearable defibrillator. The LifeVest is worn by patients who are at a risk of sudden cardiac arrest. Zoll said more than 2,000 patients are currently using the product. The company aims to increase its inventory to support further growth.

A Dutch study showed that people who took preventive doses of the statin pills, such as Lescol, before and after their operations to get an artery unclogged or repaired were much less likely to die or have a heart attack afterward. Statins are widely prescribed to reduce cholesterol and prevent heart disease.

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.