HeartWare International, a provider of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, has reported that the data from its international clinical trial and commercial experience of the HeartWare Ventricular Assist System showed a survival rate of 90% at six months and an actuarial survival rate of 86% at 12 months post implant.
The data presented at International Society for Heart and Lung Transplantation (ISHLT) include all 50 patients enrolled in the company’s international clinical trial, as well as the first 50 commercial patients. Survival rates were identical between the commercial and clinical groups, with 45 of 50 patients (90%) alive at the 180-day mark, and the reported adverse events were similar in each group.
HeartWare said that the enrollment in the international clinical trial was completed in December 2008, while the first 50 commercial implants occurred between January and September in 2009. In all, 10 centers including five clinical trial as well as five commercial sites in five countries contributed to the data set. The average age of the 100-patient pool was 50.5 years old, with the youngest being 16 years old.
Duration of support averaged 444 days in the clinical trial population, compared with 203 days in the recently implanted commercial group. The longest duration of support was 1,108 days. Seven patients were transplanted within 180 days in the clinical trial group, compared to four in the commercial group.
Reportedly, in the US, HeartWare is conducting the Advance clinical trial in which 140 patients at 30 US clinical sites received HeartWare HVAD pumps, making it the largest bridge-to-transplant pivotal trial to date. Enrollment in Advance was completed in February 2010, and subsequent to the expected conclusion of patient followup in August 2010, HeartWare anticipates filing a Premarket Approval Application (PMA) by year end.
Doug Godshall, CEO and president of HeartWare, said: “In each of the past three years, we have met and presented at ISHLT, and thanks to longer followup, we have been able to demonstrate more evidence of effectiveness of our HeartWare Ventricular Assist System. We are delighted that in a sicker cohort across a broader spectrum of sites our strong survival data was maintained in the commercial setting.”
Dr Strueber, a principal investigator in the original international trial, said: “14 percent of the implants were conducted by thoracotomy, with 86 percent through a typical sternotomy, thereby reinforcing the versatility of the HeartWare HVAD pump and potential for less invasive procedures in the future.”