Akesys Medical and Elixir Medical Corporation said today that it implanted its 1st Prava sirolimus eluting bioresorbable peripheral scaffold for the treatment of blockages in the superficial femoral artery.
The scaffold was developed to keep the large artery in the thigh open and restore blood flow to the leg and resorb into the body, making us of the bioresorbable tech licensed to Akesys by Elixir.
Akesys touted its stent as extending drug release over 6 months and sustaining initial clinical outcomes over the long term compared to shorter duration drug-eluting balloons.
Both companies said they partnered to evaluate the Prava scaffold in the DESappear study, a single-arm, multicenter trial slated to enroll 60 patients with symptomatic atherosclerosis in the SFA. Researchers plan to examine the safety and efficacy of the implants, looking out for freedom from restenosis or target lesion revascularization over 6 months. A 36-month follow-up is planned for the trial.
Prinicipal investigator of the trial, Dr. Andrew Holden of Auckland City Hospital, implanted the 1st Prava in a 66 year-old patient with 45mm of disease in the mid-SFA and 80% blockage, according to the Sunnyvale, Calif.-based company.
“Akesys is proud to have developed this important new therapy option for physicians to treat their patients suffering from debilitating peripheral disease,” Akesys Medical and Elixir Medical CEO Motasim Sirhan said in prepared remarks. “We are confident that the Prava scaffold system will meet the challenges of the SFA vasculature and demonstrate long-term, sustained results to become a valuable therapy in the treatment of SFA disease.”
“The DESappear Study is an important milestone in the pursuit of bringing innovative therapies with state-of-the-art bioresorbable technologies to treat a vulnerable population of patients with PAD,” Dr. Marc Bosiers of the AZ St Blasius Hospital in Dendermonde, Belgium, added. “I am excited to be working with Akesys Medical with the goal to bring this vital product to the clinic.”
“The diabetic patient with short distance leg claudication demonstrated zero percent residual stenosis following the procedure with the Prava scaffold and has recovered well,” Dr. Holden said. “The Prava scaffold’s easy deliverability for treatment and its excellent structural support to the vessel without leaving behind a permanent metallic implant has the potential to transform treatment options for physicians like me to greatly enhance patient outcomes.”
