The FDA accepted HeartWare International Inc.’s (NSDQ:HTWR) application for pre-market approval of its Advance clinical trial, even as positive results from another trial of its heart pump hit the Journal of the American College of Cardiology.
Framingham, Mass.-based HeartWare said the federal watchdog agency will review its PMA application for the Advance bridge-to-transplant trial, according to a federal Securities & Exchange Commission filing.
Results from a separate trial, a 50-patient “initial clinical evaluation” of HeartWare’s left ventricular assist device, showed that 90 percent of patients implanted with the device were alive after six months. The device is designed to keep patients with severe heart disease alive until they either recover or receive a heart transplant.
"Of the 50 patients, 20 (40 percent) received transplants, 4 (8 percent) had the pump explanted after myocardial recovery, and 17 (34 percent) continue support at 2 years. Nine (18 percent) patients died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic stroke (n = 3). The actual survival at 6, 12, and 24 months was 90 percent, 84 percent, and 79 percent, respectively. In the survivors, measures of quality of life showed a significant improvement over baseline values. Significant improvements were found for recognition memory at 3 months after implant (p = 0.006). The most frequent adverse events were infection and bleeding," according to the JACC report. "Patients with end-stage heart failure can be safely and effectively supported by the HeartWare ventricular assist system with improved quality of life and neurocognitive function."
In late February, HeartWare shares slipped on new that a hospital in Milwaukee suspended its participation in a clinical trial after a patient in the study developed a bloot clot that caused the HeartWare VAD to malfunction.
Dr. Salpy Pamboukian, who wrote an editorial accompanying the JACC report, told heartwire that the risk of blood cots and bleeding "are part of the business" of VAD therapy. Now that the HeartWare device and an older VAD made by Thoratec Corp. (NSDQ:THOR) have proven to be largely safe and effective, Pamboukian said, the obstacle to widespread use of the devices is acquainting cardiologists with the devices’ efficacy.
"When they see the patients on the device and see the technology in action and how well the patients do, that’s really a selling point," she told heartwire, adding that her practice often arranges for referring physicians to meet with patients after their VAD implantations "so the referring physician can see the outcome of the referral. That’s been a very powerful mechanism for increasing referrals in the community."