Boston Scientific Launches Drug Eluting Stent Solution to Treat Severe Lesions Below the Knee

Natick, Massachusetts (ots/PRNewswire) -

Innovative Stent Solution to treat patients with Critical Limb
Ischemia

Boston Scientific has launched in European countries the PROMUS
ELEMENT(TM) PLUS BTK (Below The Knee) Everolimus-Eluting Stent System
for the treatment of certain severe peripheral artery lesions. The
Drug Eluting Stent (DES) has CE Mark approval for both Monorail and
Over-The-Wire versions and will be available immediately.

PROMUS ELEMENT(TM) PLUS BTK is indicated for the treatment of
Critical Limb Ischemia (CLI) or severe lower leg claudication in
infrapopliteal lesions. Critical Limb Ischemia is a severe
obstruction of the arteries which markedly reduces blood flow to the
extremities (in most cases feet and legs) and has progressed to the
point of severe pain at rest, non-healing wounds or gangrene. CLI
appears in about 500 to 1,000 new cases per million people every year
in Europe. This highly debilitating disease is usually caused by
obstructive atherosclerotic arterial disease and is associated with a
very high morbidity and mortality risk.

In patients with CLI, restoring and maintaining maximum blood
flow to the legs is critical to helping reduce the risk of limb
amputation. Stand-alone Percutaneous Transluminal Angioplasty (PTA),
the current standard for treatment of Below-The-Knee arterial
disease, is often not enough to keep blood vessels open due to
complications that can re-occlude the vessel. These complications are
often treated with bare metal stents. Several randomized controlled
clinical trials have demonstrated that Drug Eluting Stents have
significantly better clinical outcomes than bare metal stents in CLI
patients. The prognosis of CLI patients treated with bare metal
stents is poor with only 50 percent of patients remaining alive and
free from major amputation one year after the diagnosis is made.

"The drug eluting stent is an important additional tool that I
use to address focal stenosis in the arteries below the knee, and
ultimately reduced amputation rates in CLI and claudicant patients,"
said Martin Kamarád, M.D., of Podlesí Hospital in Trinec, Czech
Republic. "In addition to the benefits of drug delivery I believe the
PROMUS ELEMENT(TM) PLUS BTK Stent offers significant advantages in
terms of properties in the design and higher resistance to
compression and less recoil thanks to its unique Platinum-Chromium
alloy and stent architecture."

The Everolimus drug and polymer used on the PROMUS ELEMENT(TM)
PLUS BTK Stent have been studied in multiple coronary randomized
clinical trials and registries such as the Promus Platinum clinical
program involving more than 1800 patients with two years follow-up.
In addition, the Platinum Chromium alloy, designed specifically for
stenting, enables enhanced visibility and excellent conformability
together with less recoil and higher radial strength.

"Thanks to our vast experience with coronary DES, which was
transferred and adapted to this specific technology to treat
Peripheral Artery Disease (PAD), we can now provide physicians an
approved DES device to address PAD challenges," said Jeff Mirviss,
President, Peripheral Interventions Division at Boston Scientific.
"We are extremely proud to offer this purpose-built device for
patients with PAD."

PROMUS ELEMENT(TM) PLUS BTK is currently available in both
Over-The-Wire and Monorail versions, offering physicians the
flexibility to select their technical preference. It also offers an
advanced low-profile delivery system designed to facilitate precise
stent placement across challenging lesions.

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About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices that are used in a broad range of
interventional medical specialties. For more information, please
visit: http://www.bostonscientific.com.

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Contact:
Simonetta Balbi, PR and Corporate Communication EMEA,
Boston Scientific, +39-3387936422 (mobile), +39-0106060281 (direct),
Balbis@bsci.com ; Steven Campanini, +1-508-652-5740 (office), Media
Relations, Boston Scientific Corporation, steven.campanini@bsci.com ;
Michael Campbell, +1-508-650-8023 (office), Investor Relations,
Boston
Scientific Corporation, investor_relations@bsci.com