The US Food and Drug Administration (FDA) has granted approval for Boston Scientific‘s new therapy that is designed to treat peripheral artery disease (PAD).
The Innova vascular self-expanding stent system is an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), which eventually leads to PAD.
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Driven by a build-up of plaque in one or more of the arteries, most often in the legs, PAD is a circulatory disorder.
In lower extremities, it can lead to painful ulcers, infections or amputation of the toes or feet.
Dartmouth-Hitchcock Medical Center, Lebanon, Department of Vascular Surgery section chief Richard Powell said: “The SFA and proximal popliteal arteries present a challenging environment for stents.
“The flexibility, radial strength and fracture resistance of the Innova stent are designed specifically for this anatomy.”
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By GlobalDataComprising a Nitinol self-expanding bare metal stent with an advanced delivery system, the Innova stent platform is available in a range of sizes, including diameters from 5mm – 8mm and lengths of 20mm – 200mm.
The system features hybrid cell architecture with open-cells along the stent body and closed cells at each end for uniform and accurate deployment, and serves as the foundation for the new Eluvia drug-eluting vascular stent, which is designed specifically for SFA.
Boston Scientific Peripheral Interventions president Jeff Mirviss said: “This is an important therapy for a disease that can have life-changing consequences, including limb amputation.
“The Innova and the Eluvia stent systems together demonstrate our commitment to improving health outcomes in the treatment of a disease affecting more than 200 million people worldwide.”
The company started a full commercial launch of the Innova stent system in the US.
Image: The Innova vascular self-expanding stent system is designed to treat peripheral artery disease. Photo: courtesy of Boston Scientific Corporation.
