HeartWare International Inc.’s implantable pump for heart-transplant candidates, under review for approval by U.S. regulators, met its primary goal in studies, according to a report.
While there are questions about missing data for 80 percent of the patients that tested the HeartWare Ventricular Assist System, the device “seems to have statistically met the primary” goal in studies, Food and Drug Administration staff said in a report today. Regulators still have concerns about stroke rates, according to the FDA staff documents.
The Framingham, Massachusetts-based company awaits a meeting of FDA advisers scheduled for April 25 to discuss the device, which draws blood from the left ventricle. While HeartWare met its patient survival goal to prove the device works, “the data require careful consideration of what clinical conclusions can be drawn,” the FDA staff said. The advisers typically take into account assessments from such staff reports.
“The documents did not contain any major negative surprises,” Larry Biegelsen, a senior analyst with Wells Fargo Securities in New York, wrote in a note to clients.
HeartWare rose 6.8 percent to $71.71 at the close in New York, the biggest single-day increase since Nov. 30.
The U.S. market for left ventricular pumps may pass $750 million in 2015, Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco, said by telephone. If HeartWare’s product also is approved for heart-failure patients who aren’t eligible for a transplant, the company may split the U.S. market with Pleasanton, California-based Thoratec Corp.’s HeartMate II by 2015, he said.
Of 140 patients who used HeartWare’s device in the final-phase trial, 92 percent survived, according to the company. This is compared with 90 percent of 499 patients in a registry for patients who use mechanical circulatory support, such as Thoratec’s HeartMate II, for advanced heart failure.
Heart failure is a progressive disease that strikes one in five Americans older than 40. It occurs when a damaged organ can’t supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments and no cure.
HeartWare was supposed to collect central venous pressure or right atrial pressure of patients using the company’s device and of those in the registry who were considered the control group. The company gathered the data for 51 percent of patients and for the rest replaced the missing value with the treatment group median, the FDA staff said.
Fifteen patients on the HeartWare device experienced strokes about six months into testing, according to the report. This data “suggest a trend toward higher stroke rates” with the pump compared to other devices, the staff wrote.
If the device is approved, the FDA said it expects HeartWare to conduct a post-approval study on the safety and effectiveness of the device by body surface area and quality of life five years after the date of implant.
The HeartWare and Thoratec devices are intended to take over for the failing heart, extending patients’ lives or gaining patients time to find a donor for transplant.
Thoratec dominates the worldwide ventricular assist device market with about 68 percent of the market share, according to data compiled by a Bloomberg analyst, Michael Manns. The company’s HeartMate had $366 million in revenue last year.
HeartMate II is approved for heart-failure patients whether they are eligible for transplantation. Thoratec said in February that a component may be improperly attached to the device and sent a guide to hospitals to ensure the component remained connected. The FDA later classified the issue as a potentially deadly defect.
HeartWare’s device is sold in Europe. It is implanted next to the heart, avoiding the abdominal surgery required by competing devices, the company said. Thoratec’s HeartMate II is placed below the diaphragm in the abdomen.
HeartWare is recruiting patients for a study on the device’s use in patients who aren’t eligible for heart transplant, according to the National Institutes of Health website clinicaltrials.gov.