|The pump component of the HeartWare Ventricular Assist Device--Courtesy of HeartWare|
The maker of the HeartWare Ventricular Assist Device (HVAD) has been hit by 6 Class I recalls since April 2014, including 5 so far this year. It's also earned 5 less severe Class 2 recalls since the device was approved in December 2012. The HVAD is a blood pump that serves as a bridge to transplantation for end-stage heart failure patients awaiting a donated organ.
The HVAD has some usability issues--though that isn't too surprising given the inherent challenges of wearing critical components of a blood pump around the waist (such as batteries), walking around with a wire underneath one's shirt that connects to the implanted pump, or being tethered to a power outlet that connects to an electrical socket (when the batteries are not in use).
In June the company ($HTWR) voluntarily sent customers and physicians a letter about the proper use and potential problems associated with the company's only approved device, earning itself a Class 1 recall notice from the FDA.
The letter reminded users to avoid unsafe (even fatal) practices like disconnecting the HVAD pump from both battery and electrical power at the same time, or accidental snagging or pulling of the driveline (the cable attached to the implanted pump that passes through the skin to connect to the controller).
The letter to customers resulted in another recall when HeartWare once again requested that it be shared, specifically with customers who complained about internal controller alarm battery failures.
Other problems and corrective actions that were designated as Class 1 recalls have been mechanical in nature.
In May the company said it would voluntarily replace all defective blood pump controllers. In its recall notice, the FDA said the "alignment guides in the power supply connector ports may wear down over time. This can cause the connection pins to become twisted or bent, and eventually prevent the patient from connecting the device controller to their VAS [Ventricular Assist System]. An interruption in this electrical connection would cause the pump to stop, which could cause serious patient injury or death."
Also in May, HeartWare warned that the device's splice kit, used to repair electrical breaks in the external part of the pump's driveline cable, can fail if exposed to excessive force.
Thoratec ($THOR) is the only other company that makes a comparable device. It just sent out a voluntary medical device correction notice after two additional patients died because they were unable to connect their pump to the backup system controller in a timely manner. And last year the company was hit with four separate Class 1 recalls of its own after four HeartMate II patients died after struggling to switch to backup system controllers when their external battery pack ran low on power.
|HeartWare's Ventricular Assist Device--Courtesy of HeartWare|
HeartWare's recalls and corrective actions are taking a toll on its bottom line. In an SEC filing, HeartWare said it incurred recall-related costs of $1.3 million in Q1 2015.
But the safety scares are unlikely to be a factor in the FDA's decision to accept (or reject) HeartWare's bid for an expanded indication permitting the HVAD to treat end-stage heart failure patients who are ineligible for a heart transplant.
That decision could easily go either way and will be dominated by matters that are more clinical in nature, such as long-term users' surprisingly high stroke rate in a clinical trial (31%), compared to 13% among patients on Thoratec's HeartMate II.
But the HVAD still demonstrated noninferiority to the HeartMate II (which already has the indication) on the broader measure that served as the primary endpoint. That's because the data shows that although HeartMate II patients were less likely to suffer from a stroke than those on the HVAD, their strokes tended to be more severe.
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