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Preemie PCI Device; HeartMate Trial Resuscitated; Repatha Access, Lawsuit

FDA approved the Amplatzer Piccolo Occluder for patent ductus arteriosus in preemies and newborns weighing as little as 2 lbs. The smaller-than-a-pea transcatheter device is the first specifically approved for such infants, Abbott announced.

The agency is giving tafamidis priority review for an indication in treating transthyretin amyloid cardiomyopathy (ATTR-CM), Pfizer announced. A decision is expected in July 2019.

FDA also cleared a design change to the SherpaPak device so that it can be used to transport small and pediatric donor hearts. (MassDevice)

Next-generation percutaneous heart pump HeartMate PHP is getting a do-over in its U.S. pivotal trial after technical issues with the pump. SHIELD II has resumed with a new composite primary endpoint and a two-part design: Enrollment prior to suspension of the trial in 2017 will be considered the feasibility population. (Trends-in-Medicine Quick Takes)

Evolocumab (Repatha) is now available to 80% of Medicare-insured users at the 60% reduced list price announced in October 2018, Amgen said. “Additionally, more patients can now fill a Repatha prescription at a retail pharmacy because a number of large payers are reclassifying Repatha as a non-specialty therapy,” the company press release noted.

In the patent fight over PCSK9 inhibitors, the Supreme Court refused to hear Amgen’s appeal of a 2017 court decision allowing Sanofi and Regeneron to continue selling alirocumab (Praluent). Amgen still has a new patent trial starting in Delaware federal court next month, FiercePharma reports.

Subanalysis of the CANVAS trial of the type 2 diabetes drug canagliflozin (Invokana) suggested a protective effect against hemorrhagic stroke, which was “based on small numbers but warrants further investigation.” (Stroke)

Medtronic and Boston Scientific are standing by their paclitaxel-eluting devices used in blood vessels in the legs, as their internal data does not support the recently published findings of increased mortality, according to executive presentations at the J.P. Morgan Healthcare Conference in San Francisco. (Star Tribune)

An estimated 4.4% of childhood cancer survivors will develop heart failure in the subsequent 40 years. (Journal of the American Heart Association)

Telestroke hospitals didn’t use more thrombolytics but did have modestly fewer complications from it and marginally fewer in-hospital deaths in an observational study in Circulation: Cardiovascular Quality and Outcomes.