Cardio

Crux Biomedical has announced FDA clearance for its novel Vena Cava Filter which uniquely features bi-directional retrieval via either the femoral or jugular vein access.

St. Jude Medical, Inc. has reported sales and net earnings for the second quarter ended June 30, 2012. Compared with the equivalent period a year ago net sales of $1.410 billion represented a decrease of 2 percent, declines in Cardiac Rhythm Management sales being somewhat offset by increases in Atrial Fibrillation and Neuromodulation revenues.

Johnson & Johnson has just announced sales of $16.5 billion for the second quarter of 2012, a decrease of 0.7% as compared to the second quarter of 2011, albeit with a significant currency loss painting a gloomier picture than the top line figures suggest.

St. Jude Medical, Inc., has gone public with initial findings from its Riata Lead Evaluation Study. The study’s phase-one results found that externalised conductors occurred in 9.3 percent of the smaller-diameter Riata ST 7F leads in the study, and in 24 percent of the larger-diameter Riata 8F leads.

TriReme Medical, Inc. has announced that it has received FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 3.5mm and in lengths from 4mm to 20mm.

Israeli company BioControl Medical has announced U.S. FDA approval to begin the second phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-centre, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure.

Critical care monitoring expert Sphere Medical Holding plc, and cardiovascular devices company Sorin Group, have jointly announced today that Sorin Group has placed an order with Sphere Medical for cardiopulmonary bypass monitors and microanalyser consumables (CPB) for delivery in Q4 2012.

New Sorin study evaluates sensitivity and positive predictive value of Sleep Apnea Monitoring (SAM) feature in implantable pacemakers.

For a drug-eluting balloon to be effective the drug needs to elute at the right rate, which German company cardionovum believes is fast. Newly commenced in vivo studies will no doubt confirm the assertion.

Initial findings from new study suggest successful delivery of PICSO® catheter and administration of PICSO® treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first-three STEMI patients.

Sorin group is to acquire CalMed, Californian manufacturer of cardiovascular cannulae, in a move which will enhance the Italian company’s offering.

Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter has received FDA 510(k) clearance for central venous pressure monitoring indication.

University of Pittsburgh’s cell-free, biodegradable artery graft results in a regenerated artery in 90 days, leaving behind no trace of synthetic graft materials in the body.

Terumo Cardiovascular Systems has issued guidance regarding what to do in the event of a false air bubble detector alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use.

St.Jude must have issued a corporate sigh of relief when its investigators concluded that the recently reported incidence of Durata ICD lead failure was most likely caused by abrasion from another lead or indeed a calcified structure, rather than the inside-out abrasion which has characterised the company’s Riata family problems.

US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.