The MAJESTIC trial -- designed to evaluate the safety and performance of the first
The Innova DES System is designed to restore blood flow in arteries above the knee, specifically the SFA and proximal popliteal artery (PPA). The stent features a unique drug-polymer combination, intended to facilitate optimal release of the drug and prevent restenosis (narrowing) of the vessel. The first implant was performed by
"The complex anatomy of the superficial femoral artery above the knee and the dynamic forces created by flexion of the knee create a challenging environment for implants like stents, leading to the potential risk of stent fracture and higher rates of restenosis," said Professor
Professor Muller-Hulsbeck serves as principal investigator of the MAJESTIC trial.
The Innova DES System consists of a Paclitaxel-coated, Nitinol, self-expanding stent loaded on an advanced, low-profile delivery system. The innovative stent architecture features a closed-cell design at each end of the stent for more consistent deployment, and an open-cell design along the stent body for improved flexibility and fracture resistance. Deployment accuracy is facilitated by a tri-axial catheter shaft designed to provide added support and placement accuracy.
"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," said
The Innova DES System is an investigational device worldwide and not available for use or sale. To download an image of the Innova DES System click here.
Keywords for this news article include: Surgery, Angiology, Drug Eluting Stent, Biotechnology Companies, Clinical Trials and Studies,
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