DESappear Trial Commences for Akesys Medical's Prava Scaffold With Elixir Medical's Bioresorbable Technology

October 20, 2016—Akesys Medical announced the successful implantation of the Prava sirolimus-eluting bioresorbable peripheral scaffold system for the treatment of blockages in the superficial femoral artery (SFA).

The procedure marks the commencement of the company’s first clinical trial, the DESappear study. The device was implanted in a patient (66 years of age), with 45 mm of disease in the mid-SFA and an 80% blockage. The procedure was performed by DESappear investigator Andrew Holden, MBChB. Prof. Holden is Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine in Auckland, New Zealand.

In the company’s press release, Prof. Holden commented, “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 to greatly enhance patient outcomes.”

The Prava scaffold’s bioresorbable technology is licensed to Akesys by Elixir Medical Corporation. Akesys has partnered with Elixir to conduct the DESappear study.

According to the company, the DESappear study is a prospective, single-arm, multicenter trial of the Prava scaffold in patients presenting with symptomatic atherosclerosis in the SFA. The trial’s primary safety endpoint is a composite of freedom from perioperative death through 30 days and freedom from major adverse limb events (defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization) through 6-month follow-up. The primary effectiveness endpoint is primary patency defined as freedom from restenosis (> 50% diameter reduction defined by duplex ultrasound) or clinically driven target lesion revascularization through 6 months. Clinical and duplex ultrasound follow-up will be held at 30 days, and 6, 12, 24, and 36 months. Akesys Medical expects to enroll up to 60 patients at 12 sites in Europe and New Zealand.

The principal coordinating investigators for the study are Marc Bosiers, MD, and Dierk Scheinert, MD. Dr. Bosiers is a vascular surgeon at AZ St. Blasius Hospital in Dendermonde, Belgium. Dr. Scheinert is Head of the Department of Interventional Angiology at University Hospital of Leipzig in Leipzig, Germany.

In the company’s announcement, Dr. Bosiers commented, “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. I am excited to be working with Akesys Medical with the goal to bring this vital product to the clinic.”