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| HeartWare's Ventricular Assist System |
Safety issues continue to nag implantable heart pump maker HeartWare International ($HTWR). The company has received a warning letter from the FDA that resulted from a January inspection by the agency of its Miami Lakes, FL, operations, management and manufacturing facility.
According to the company, the FDA letter cited four areas for HeartWare to address: procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action; maintaining records related to investigations and validation of computer software used as part of production or quality systems. HeartWare said it will respond to the letter within the required 15 days and it "expects to implement new and enhanced systems and procedures" and to "perform additional actions as may be required to resolve the issues raised in the FDA communication." The FDA letter does not restrict use of HeartWare devices, the company said.
Last December, the FDA issued a Class I recall for the company's Ventricular Assist System due to a potential failure of the locking mechanism for the pump driveline connector. That problem could result in the pump stopping unexpectedly, which could lead to patient injury or death.
Then on May 1, the company also issued a statement noting problems related to the Ventricular Assist System batteries such as earlier-than-expected depletion. The company said it would replace any fully charged battery that lasts less than two hours.
At that time, the company said there had been no patient deaths due to faulty batteries. But it did report three deaths possibly related to power source management--two due to the simultaneous disconnection of both power sources and one with a battery that had exceeded its expected useful life. Another death had initially been reported as a potential power management issue, but was later found to be due to an accidental disconnection of the driveline. These occurred between Jan. 1, 2011, and March 31, 2014.
FDA approved the Ventricular Assist System in November 2012 as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The device also has the European CE mark. During the first quarter of 2014, the Ventricular Assist System resulted in $66.5 million in revenue with 665 units sold. Revenue from the system increased 42% from $23.1 million during the first quarter of 2013.
HeartWare shares gained 11% to $94.43 on the May 1 announcement, but declined 2% to $88.07 in early trading on the June 4 disclosure. The company has a market cap of $1.5 billion.
- here's the press release from the company on the FDA warning letter