Boston Scientific Corporation has announced that
it has received FDA approval for the REBEL™ Platinum Chromium Coronary Stent
System. This is company's latest generation bare-metal stent for the treatment
of coronary artery disease (CAD). Bare-metal stents continue to play an
important role in the treatment of CAD and represent a significant portion
of the global stent market. The company announced CE Mark for the Rebel
Stent System in February.
The REBEL Stent System expands the Boston
Scientific family of stents featuring its proprietary platinum chromium (PtCr)
alloy and a customized stent architecture design. The REBEL Stent offers
the identical stent platform as the Promus PREMIER™ Drug-Eluting Stent (DES)
but without the Everolimus drug.
"Bare-metal stents are an important part of
our practice, as not every patient can receive a drug-eluting stent. This
new bare-metal stent has the same great visibility and deliverability as the
PREMIER DES but allows me to treat patients who are not candidates for DES
therapy," said John C. Wang, M.D., of Medstar
Union Memorial Hospital, Baltimore, Md. "In
addition, the platinum chromium architecture provides great radial strength
with low recoil, which is particularly important in patients receiving
The REBEL Stent System features unparalleled
visibility, low recoil, exceptional radial strength and fracture resistance,
while improving axial strength and deliverability. Its enhanced
low-profile delivery system also features a shorter, more visible tip, a
dual-layer balloon and a Bi-Segment™ inner lumen catheter designed to
facilitate precise stent delivery across challenging lesions.
"Boston Scientific is committed to
developing the best treatment options for all patients with coronary artery
disease," said Kevin Ballinger, president,
Interventional Cardiology, Boston Scientific. "Launching the Rebel Stent
System in the U.S. is another important step to ensure that we offer physicians
the most differentiated and broadest product portfolio possible."
Of note, Dr. Wang presented data from the OMEGA
clinical trial evaluating the REBEL Stent System in February at the
Cardiovascular Research Technologies conference in Washington,
D.C. OMEGA is a single arm, multi-center trial in the U.S. and Europe and the first reported results showed low event
rates at nine months.
The REBEL Stent System is offered in a matrix of 46
sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm
on a Monorail™ platform. This provides physicians with a range of options
designed to best suit patient needs.