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| HeartWare's Ventricular Assist System--Courtesy of HeartWare International |
HeartWare International ($HTWR) is facing FDA ire for its ventricular assist system, but regulatory pushback hasn't seemed to put a damper on earnings. The company charted double-digit growth during the second quarter, fueled in part by record sales for its signature device in domestic and international markets.
The Framingham, MA-based company's revenue jumped 38% to $70.1 million in Q2, bolstered by sales of its HeartWare Ventricular Assist System (HVAD) for patients with advanced heart failure. HeartWare sold 674 devices globally during the second quarter and generated $36.9 million in revenue for 338 units sold in the U.S.--a 47% increase from the same quarter last year. More than 6,000 patients in 40 countries have been outfitted with the device, and the company plans on continuing to invest in clinical trials and next-generation therapies to diversify its portfolio, CEO Doug Godshall said in a statement.
But it's not all smooth sailing for HeartWare, as the company faces ongoing issues related to its HVAD system. Last year, the FDA slapped the device with a Class I recall due to a potential failure of the locking mechanism for the pump driveline connector--a problem that could result in patient injury or death. In January, an agency inspection of HeartWare's Miami Lakes, FL, facility revealed software and manufacturing flaws tied to the company's ventricular assist system. The FDA issued a formal warning to the company earlier this month, giving HeartWare one month to correct safety issues.
"[O]ur highest internal priority remains addressing and remedying the observations raised by FDA following an inspection at our Miami Lakes, Florida, facility earlier this year," Godshall said in a statement.
The company also plans on expanding its circulatory support portfolio through its recent acquisition of CircuLite. In December 2013, HeartWare agreed to pay as much as $350 million to get its hands on the company's Synergy device for individuals with less severe heart failure, targeting a larger patient population and adding to its current offerings, Godshall said in a statement at the time of the deal. The product is already CE marked, but CircuLite said last year that it would relaunch the device in a phased rollout after upgrading the implant to address unspecified issues.
- read the release
Special Report: Top 10 device and diagnostic FDA approvals of 2012 - HeartWare's Ventricular Assist System