Diagnosing heart disease in women has long been a special challenge for doctors because women's symptoms tend to be atypical and far less predictable than heart disease symptoms in men.

It's not every day a company attempts a do-over on a previously-failed clinical program but that's exactly what Medtronic (Dublin, Ireland) appears to be doing with renal denervation for uncontrolled hypertension. The company has initiated a new program, dubbed SPYRAL HTN, that will include two global studies designed to address the confounding factors encountered in its SYMPLICITY HTN-3 trial, including medication, patient population, and procedural variability.

The FDA has approved, for the first time, a transcathter heart valve for valve-in-valve (VIV) procedures in patients whose surgical aortic heart valves have failed. The agency expanded the approved use of Medtronic's (Dublin, Ireland) CoreValve system for VIV procedures in patients in need of a second valve replacement who are at high or extreme risk for complications associated with traditional open-heart surgery.

The FDA has granted pre-market approval (PMA) for the use of Abiomed's (Danvers, Massachusetts) Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention (PCI) procedures. Abiomed said the approval is based on clinical data the company submitted to the FDA to support this PMA as part of the 515 initiative.