MARLBOROUGH, Mass.,
Aug. 19, 2015 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) has received Food
and Drug Administration (FDA) approval for the Innova™ Vascular
Self-Expanding Stent System, an advanced treatment option for
patients with narrowing or blockages in the superficial femoral
artery (SFA) or proximal popliteal artery (PPA). This can cause
peripheral artery disease (PAD), a circulatory disorder that
results from a build-up of plaque in one or more of the arteries,
most often in the legs. PAD of the lower extremities can lead to
painful ulcers, infections, or amputation of the toes or feet. The
company has commenced a full commercial launch of the Innova Stent
System in the U.S.
"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," said Richard Powell,
M.D., section chief, Department of Vascular Surgery, Dartmouth
Hitchcock Medical Center, Lebanon,
N.H., professor of Surgery and Radiology at the Geisel
School of Medicine, and global principal investigator of the
SuperNOVA trial, evaluating the safety and effectiveness of the
Innova Stent System. "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."
The Innova stent platform consists of a Nitinol self-expanding
bare metal stent with an advanced delivery system, and is available
in a range of sizes, including diameters from 5 mm to 8 mm and
lengths of 20 mm to 200 mm. It features a hybrid cell architecture
with open-cells along the stent body and closed cells at each end
for uniform and accurate deployment. This stent platform serves as
the foundation for the new Eluvia™ Drug-Eluting Vascular Stent,
designed specifically for the SFA. The Innova Stent System was
designed with an intuitive triaxial delivery system for precise,
predictable stent placement and uniform deployment.
"The Innova delivery system allowed me to place the stent
smoothly and accurately," said Jaafer
Golzar, M.D., interventional cardiologist, Advocate Christ
Medical Center, Oak Lawn, Ill.,
and the first to use the Innova Stent System in a clinical
procedure following FDA approval. "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
also a clinical assistant professor, University of Illinois at Chicago and director of
Limb Salvage & Endovascular Intervention, Advocate Trinity
Hospital, Chicago.
"This is an important therapy for a disease that can have
life-changing consequences, including limb amputation," said
Jeff Mirviss, president, Peripheral
Interventions, Boston Scientific. "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."
Get more information about the Innova Stent System. View or
download an image of the Innova Stent System. The Innova Stent
System received CE Mark approval in May 2012. The Eluvia
Stent System is pending CE Mark and is not available for use or
sale in the U.S.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the
world. As a global medical technology leader for more than 35
years, we advance science for life by providing a broad range of
high performance solutions that address unmet patient needs and
reduce the cost of healthcare. For more information, visit
www.bostonscientific.com and connect on Twitter and Facebook.
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CONTACTS
Media: Ryan Davenport
Global Media Relations
Boston Scientific Corporation
763-494-2664 (office)
Ryan.davenport@bsci.com
Investors: Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific Corporation