FDA Approves Boston Scientific's Innova Stent System for SFA/PPA Treatment

August 19, 2015—Boston Scientific Corporation announced that the company has received US Food and Drug Administration (FDA) approval for the Innova vascular self-expanding stent system to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA) or proximal popliteal artery (PPA). The company has commenced a full commercial launch of the Innova stent system in the United States. The Innova stent system received European CE Mark approval in May 2012.

According to Boston Scientific, the Innova stent platform consists of a nitinol, self-expanding, bare-metal stent with an advanced delivery system. It is available in diameters of 5 to 8 mm and lengths of 20 to 200 mm. The Innova platform features a hybrid cell architecture with open cells along the stent body and closed cells at each end for uniform and accurate deployment. The Innova stent system was designed with a triaxial delivery system for precise, predictable stent placement and uniform deployment, the company said.

Additionally, the Innova stent platform serves as the foundation for the new Eluvia drug-eluting vascular stent, which is designed specifically for the SFA. The Eluvia stent system is pending European CE Mark approval and is not available for use or sale in the United States, advised the company.

Richard Powell, MD, serves as global principal investigator of the SuperNOVA trial that is evaluating the safety and effectiveness of the Innova stent system. Dr. Powell commented in the company’s press release, “It is gratifying to be able to offer this minimally invasive therapy to improve the quality of life in those patients who suffer from PAD. The SFA and PPA present a challenging environment for stents. The flexibility, radial strength, and fracture resistance of the Innova stent are designed specifically for this anatomy.” Dr. Powell is section chief, Department of Vascular Surgery, at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and professor of Surgery and Radiology at Dartmouth’s Geisel School of Medicine.

Jaafer Golzar, MD, was the first to use the Innova stent system in a clinical procedure after FDA approval. He stated, “The Innova delivery system allowed me to place the stent smoothly and accurately. The first step to achieving an optimal outcome is accurate placement, and then stent properties like radial strength and flexibility come into play.” Dr. Golzar is an interventional cardiologist at Advocate Christ Medical Center in Oak Lawn, Illinois. He is also a clinical assistant professor, University of Illinois at Chicago and director of Limb Salvage & Endovascular Intervention at Advocate Trinity Hospital in Chicago, Illinois.