Boston Scientific has initiated the MAJESTIC trial designed to evaluate the safety and effectiveness of Innova peripheral vascular self-expanding DES system in treating superficial femoral artery (SFA) lesions.
The first patient has been implanted with Innova drug-eluting stent (DES) system at Auckland City Hospital, Auckland in New Zealand.
The MAJESTIC trial is expected to enrol 55 patients across 15 centres in Europe, Australia and New Zealand.
The Innova DES stent is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral artery disease (PAD).
It has been specifically designed for use in the SFA and proximal popliteal artery (PPA) and to provide physicians with an effective alternative to treat peripheral artery disease in the challenging vascular environment above the knee.
Diako Flensburg vascular centre deputy chairman Stefan Muller-Hulsbeck said the complex anatomy of the superficial femoral artery above the knee and the dynamic forces created by flexion of the knee results in a challenging environment for implants.
"The deliverability, flexibility and durability in combination with the anti-restenotic characteristics of the Innova DES System make it ideal for use treating lesions in these critical arteries," Dr Muller-Hulsbeck said.
The stent features a unique drug-polymer combination, intended to facilitate optimal release of the drug and prevent restenosis (narrowing) of the vessel.
The Innova DES System comprises a Paclitaxel-coated, Nitinol, self-expanding stent loaded on an advanced, low-profile delivery system.
The stent body provides enhanced flexibility, radial strength and fracture resistance due to its closed-cell design and uniform, open-cell structure.
A tri-axial catheter shaft of the Innova system will offer added support and placement accuracy.
Boston Scientific peripheral interventions president Jeff Mirviss said millions of patients around the world suffer the debilitating effects of peripheral artery disease (PAD), including amputation and an elevated risk for major cardiovascular events.
"The Innova DES System builds upon the Boston Scientific leadership in both peripheral vascular devices and drug-eluting technologies, and we look forward to bringing this meaningful innovation forward to improve outcomes for patients with PAD," Mirviss said.
Currently, the Innova DES is an investigational device worldwide and not available for use or sale.
Peripheral vascular disease (PVD) is a circulatory disorder that results from a build-up of plaque in one or more of the arteries of the legs.
Image:The Innova DES System. Photo: courtesy of Boston Scientific Corporation.