Medical drug-device company Akesys Medical has reported its conduction the first clinical trial with Elixir Medical, and a successful implant of its PRAVA Sirolimus Eluting Bioresorbable Peripheral Scaffold System for blockage in superficial femoral artery (SFA) within peripheral vascular disease.
The PRAVA scaffold has been designed to maintain the large artery in the thigh open and restore blood flow to the leg, then resorb the blood into the body while leaving no permanent implant behind.
It is based on a developing technology licensed to Akesys by Elixir Medical.
The companies are conducting the prospective, single-arm, multicentre DESappear Study of the PRAVA scaffold in an estimated 60 patients exhibiting symptomatic atherosclerosis within the SFA.
The study is primarily focused on determining the safety in the form of reduced risk of perioperative death and major adverse limb events.
The efficacy endpoint of the study is to achieve freedom from restenosis or clinically driven target lesion revascularisation.
DESappear investigator Dr Andrew Holden said: “The diabetic patient with short distance leg claudication demonstrated 0% residual stenosis following the procedure with the PRAVA scaffold and has recovered well.
“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.”
The PRAVA sirolimus eluting bio-resorbable peripheral scaffold system offers a combination of deliverability with robust vessel support, controlled drug release over six months and scaffold degradation within one year.
The extended drug release enables the scaffold to sustain the initial clinical outcomes over the long term when compared to the shorter-duration, drug-eluting balloons.
These features enable the PRAVA scaffold to combat challenges of the SFA where the application of mechanical force and deformation can create difficulties for permanent metallic implants such stent fracture and irritation of the vessel wall, potentially causing restenosis.