Week in Review: FDA clears perfusion balloon catheter | Doc files lawsuit over salary | Edwards spends $1.2B | Medicare reform

The newly cleared device includes a rapid-exchange catheter and a helical balloon that takes the shape of a hollow cylinder when inflated.

A veteran cardiologist in Boston has filed a new lawsuit that claims she is earning a much lower salary than a less experienced male colleague. She believes this violates the Massachusetts Equal Pay Act.

The new PREVENT CVD risk calculator could result in more than 16 million heart patients who are no longer eligible for preventive therapy. These significant changes “carry the potential for both benefit and harm," researchers wrote in JAMA.

While JenaValve is known for its Trilogy Heart Valve System, a device designed specifically to treat aortic regurgitation, Endotronix specializes in developing heart failure technologies. The news comes after Edwards sold its critical care business for $4.2 billion in June, saying it would double down on its structural heart portfolio. 

The new medical device correction only includes a select number of devices. Abbott said they produce inaccurate readings, putting patient health at risk. 

The Elixir Medical DynamX sirolimus-eluting coronary bioadaptor is designed to improve coronary luminal diameter, help restore hemodynamic modulation and reduce plaque progression in patients with de novo coronary artery lesions.

Nearly 130 healthcare groups are urging Congress to pass legislation that would provide relief to U.S. physicians struggling to keep up with wave after wave of payment reductions.

LVOT obstruction after TMVR remains a significant concern among structural heart cardiologists. Predicting the risk of LVOT obstruction typically requires CT, which comes with certain disadvantages compared to other imaging options.

Compounded semaglutide injectable products are at the heart of these concerns. While the FDA says compounded drugs “can serve an important medical need for patients,” the agency does not approve these new formulations, increasing the risk of complications. 

Reviewing a patient's medical history can help care teams select the optimal post-TAVR oral anticoagulation strategy.