The company claims that the lack of suturing allows the super-elastic Perceval valve to achieve optimal effective orifice area, resulting in “excellent hemodynamics.” LivaNova said procedures utilizing the Perceval valve result in shorter intensive care unit stays, reduced ventilation time and less blood transfusions.
“The clinical experience with the Perceval valve has been positive on multiple fronts as measured by reduced cross-clamp time, great hemodynamic performance, low structural valve deterioration and freedom from reoperation up to 5-year follow-up. Persist-AVR is designed to confirm these results compared to standard sutured stented valves. Moreover, the trial will demonstrate how the use of Perceval in aortic valve surgery is linked with significant cost savings, driven primarily by reduced procedural costs and reduced hospital stay,” trial steering committee member Dr. Thierry Folliguet said in a press release.
The Persist-AVR trial is slated to enroll over 1,200 patients with severe symptomatic arotic stenosis or steno-insufficiency in patients who are candidate for surgical replacement of their native aortic valves. In the trial, the company’s Perceval valve wil lbe compared against standard sutured bioprosthesis in patients with aortic valve disease, the comapny said.
“We know that Persist-AVR is a landmark clinical trial, being the first randomized study in 30 years in the field of valvular surgery. Its initiation is a great endeavor in the cardiac surgery communities. More than 60 centers around the world will be recruited pointing out the strong interest generated by Perceval. We look forward to obtaining promising data for the use of Perceval in the daily aortic valve replacement setting,” principal investigator Dr. Theodor Fischlein of Germany’s Paracelsus Medical University Cardiovascular Center said in prepared remarks.
The primary endpoint of the trial is non-inferioirty of major adverse cardiac cerebrovascular events at 1 year, according to VARC-2 criteria. A 2-year enrollment period is planned for the trial with a yearly follow up every year for 5-year, with a primary endpoint expected in 2019.
“As the 1st trial of its kind, the Persist-AVR study is a significant milestone for LivaNova, the healthcare community and patients worldwide. We are proud to support this important trial. We anticipate its results could significantly impact daily practice and establish the Perceval sutureless valve as the prosthesis of choice for future heart valve surgeries,” cardiac surgery biz unit prez Michel Darnaud said in a prepared statement.
Last month, LivaNova announced the 1st U.S. implantation of its Perceval sutureless aortic valve replacement. The implantation was headed by Dr. Douglas Johnson and Dr. Eric Roselli at the Cleveland Clinic in Ohio, with the patient receiving 2 valves during the operation.
In January, the FDA approved LivaNova’s Perceval sutureless replacement heart valve. London-based LivaNova said it planned to begin commercial distribution of the Perceval valve, which is designed to replace the heart’s aortic valve using a self-anchoring frame.