CardioExchange Archive

May 28th, 2014

FDA Approves Novel Implanted Sensor to Monitor Heart Failure

Larry Husten, PHD

The FDA announced today that it has approved the CardioMEMS HF System. The small implantable device provides daily pulmonary artery (PA) pressure measurements to guide physicians in their treatment of  NYHA Class III heart failure patients who have been hospitalized for heart failure in the previous year. The system consists of three parts: a small permanent sensor implanted […]

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May 21st, 2014

Medtronic and Edwards Lifesciences Resolve Patent Disputes

Larry Husten, PHD

After years of protracted and often bitter litigation in the U.S. and abroad, Edwards Lifesciences and Medtronic today announced a broad resolution to all their patent disputes over transcatheter heart valves. Medtronic will pay more than a billion dollars over the course of the agreement, which lasts until April 2022. Edwards will first receive a one-time payment of $750 million, followed […]

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May 19th, 2014

Hospitalizations for AF Are on the Increase

Larry Husten, PHD

In recent years there has been an explosion of interest in atrial fibrillation (AF). Now a new study published in Circulation finds that hospitalizations for AF are on the increase, and this may have important implications for the delivery and economics of health care in the coming years. Researchers analyzed data  from nearly 4,000,000 hospitalizations in which AF […]

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May 18th, 2014

Statins Disappoint In COPD And ARDS

Larry Husten, PHD

Two NHLBI studies have failed to find any benefit for statin therapy in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). Previous observational studies had raised the possibility that statins, perhaps due to their anti-inflammatory effects, might improve outcomes in people with these serious diseases. But both trials were stopped early by […]

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May 16th, 2014

FDA Turns Back Novel Drug for Acute Heart Failure

Larry Husten, PHD

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. The FDA decision was not unexpected since earlier this […]

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May 15th, 2014

Exercise: Can There Be Too Much of a Good Thing?

Larry Husten, PHD

In recent years researchers have developed a more complicated view of the relationship of health and exercise. Although observational studies have consistently shown that some physical activity is better than none, studies that have drilled deeper into the data suggest that these health benefits may be curtailed in people who exercise very frequently or very […]

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May 14th, 2014

BMJ Articles Critical of Statins Provoke Kerfuffle

Larry Husten, PHD

The authors of two BMJ articles have withdrawn statements about the adverse effects of statins. The papers inaccurately cite an earlier publication and therefore may overstate the incidence of adverse effects. As a result, the two papers have drawn much criticism and set off a kerfuffle involving the editor of BMJ and a highly prominent British trialist who is demanding a […]

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May 13th, 2014

A Second Darapladib Phase 3 Trial Misses Its Endpoint

Larry Husten, PHD

GSK said today that a large phase 3 trial of a once highly promising drug had failed to meet its primary endpoint. Last year the company announced that another phase 3 trial with the same drug had failed. GSK said it would “further analyse the data and better understand the findings” but that, for now at least, […]

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May 13th, 2014

FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa

Larry Husten, PHD

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with […]

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May 9th, 2014

Routine Defibrillation Testing Not Required During ICD Implantation

Larry Husten, PHD

Although commonly performed, routine defibrillation testing has never been shown to be safe or necessary. Now a new study, presented yesterday at the Heart Rhythm Society meeting in San Francisco, offers evidence that although routine testing is generally safe it may increase complications without producing any improvement in outcomes. In the SIMPLE (Shockless Implant Evaluation) trial, sponsored by Boston […]

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