LivaNova announced that the U.S. Food and Drug Administration has announced the approval of their Perceval Sutureless Heart Valve. The approval was issued Jan. 8 and is effective immediately, and LivaNova indicated that it will begin commercial distribution of the device in the United States over the coming quarter.
According to an FDA summary document, the Perceval Sutureless Heart Valve is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The self-expanding stent frame consists of a tissue component made from bovine pericardium and a self-expandable nitinol stent, along with a dedicated delivery system that allows physicians to position and anchor the valve suturelessly.
The Perceval heart valve is supplied unmounted and must be loaded onto an accompanying holder by reducing the valve size using a supplied polycarbonate collapser. The holder is used for sternal approaches and includes a rigid shaft with an end section that houses the valve prosthesis during delivery. A separate holder, approximately 3 cm longer, is also available for minimally invasive procedures. After implantation, the physician uses the a post-dilation catheter to expand the valve in situ.
Perceval’s approval was based upon the results of a pivotal European study performed to assess the device, the CAVALIER (Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark) trial. The prospective, multicenter, nonrandomized clinical study was conducted at 26 investigational sites in Austria, Belgium, England, France, Germany, and the Netherlands.
Patients were treated between Feb. 23, 2010, and Sept. 30, 2013, and the database for the PDA-assessed data collected through Nov. 5, 2014, and included 658 patients.
The differences between the New York Heart Association (NYHA) class at 12 months and the baseline were calculated. In total, 77.5% of patients showed a decrease of NYHA equal to at least one class, whereas 19.7% of patients remained stable over the time. Only 2.8% of patients showed a worsened clinical status.
Reduction in mean gradients and increase in effective orifice area were both observed at 1 year follow-up, according to the FDA report.
At the 1-, 2-, and 3-year follow-up time points, 75.1% or greater of the implanted patients with available data had improved by one to three classes and at the 4-year follow-up time point 72.6% of the patients had improved by one to three classes, according to the report. In addition, at the 1-, 2-, and 3-year follow-up time points, 92.9% or greater of the patients were in NYHA Class I and Class II, and at the 4-year follow-up time point, 86.3% of the patients were in NYHA Class I and Class II.
Although there was a predominance of women in the study population (64.4%), patients of both sexes demonstrated acceptable hemodynamic outcomes and significant improvement in functional status, according to the FDA summary.
Sutureless valves are considered to have a promising future according to a recent international consensus panel recommendationpublished online in the European Journal of Cardio-Thoracic Surgery (2015 Oct 29. doi: 10.1093/ejcts/ezv369). The report assessed various benefits of sutureless and rapid deployment technology, and concluded these devices “may represent a helpful tool in aortic valve replacement for patients requiring a biological valve.” However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves, they concluded.