As if Abbott Laboratories hasn't had enough to celebrate this year, the company just scored FDA approval for the use of its Heartmate 3 pump as a destination therapy. The approval, which CEO Miles White hinted about earlier in the week, is a big win for Abbott – and an even bigger win for advanced heart failure patients.
The approval means that doctors can now offer the HeartMate 3 system to patients who are not eligible for a transplant. These patients will live with the device for the rest of their lives.
For advanced heart failure patients who can no longer rely on earlier stage treatment options, left ventricular assist devices (LVADs) take the workload off a weakened heart by pumping blood through the body. According to Nir Uriel, MD, director of heart failure, transplant, and mechanical circulatory support at the University of Chicago Medicine, about a quarter of a million people are living with advanced heart failure. Many of these people will need a heart transplant, but only a few thousand will receive one, he said.
"The destination therapy approval for Abbott's HeartMate 3 device now gives these patients new hope that they can receive a heart pump clinically proven to mitigate challenges we've historically confronted with this therapy—stroke and blood clotting—while also offering survival rates on par with transplant," Uriel said.
Abbott acquired the HeartMate 3 system through its $25 billion acquisition of St. Jude Medical, which was finalized in early 2017. The system was originally developed by Thoratec, which St. Jude bought in 2015. The device uses a technology called Full MagLev (fully magnetically-levitated) flow, which is intended to reduce trauma to the blood passing through the pump while improving flow.
The HeartMate 3 system includes the LVAD pump as well as other components that help power and monitor the technology including an external, wearable controller and battery system. The HeartMate 3 system received a CE mark in Europe for both short-term and long-term support in October 2015 and FDA approval for short-term support in August 2017.
White gave investors a heads up about the latest HeartMate 3 news during Abbott's third-quarter earnings call, saying that FDA approval of a new claim for the device was expected "imminently." During the call, White emphasized the company's highly productive pipeline and credited a lot of that strength to the St. Jude acquisition.
The new FDA approval was supported by data from the MOMENTUM 3 trial, which enrolled more than 1,000 patients with New York Heart Association Class IIIB or IV heart failure. Two-year data on the first 366 patients enrolled in the study were presented at the American College of Cardiology's annual meeting in March and simultaneously published in the New England Journal of Medicine. The study showed an unprecedented survival rate of 82.8% at two years, and rates of suspected pump thrombosis (clotting of blood) remained very low at 1.1%. The data also showed the lowest stroke rate (10%) ever published for a continuous-flow LVAD at two years.
No medical device is perfect, however, and just two months after the two-year MOMENTUM 3 data was published, Abbott warned doctors that outflow graft twisting may occur after the LVAD is implanted. The problem can trigger a persistent low-flow alarm that may signal a potential safety risk to patients, such as blood flow or clotting. As of May 2017, there had been 32 reports of outflow graft twisting (an incidence rate of 0.72%), including reports of low blood flow, clotting, and three patient deaths. Twisting of the outflow graft can occur at any point after the LVAD is implanted, Abbott said.